Compliance During Orthodontic Treatment with Removable Appliances When Using Two Types of Reminders, Assessed by Timer Modules - a Pilot Study

Compliance during orthodontic treatment with removable appliances when using two types of reminders, assessed by timer modules - A pilot study

Erik Frilund Lisa Widegren

Supervisor: Ph.D. Mikael Sonesson, Department of Orthodontics, Faculty of Odontology, Malmö University

Master thesis in Odontology (30 ECTS) Malmö University Dentistry Faculty of Odontology February, 2015 205 06 Malmö

ABSTRACT

INTRODUCTION AND PURPOSE: Earlier studies on compliance and orthodontics have shown that one of the best ways to increase compliance is by supervising the wearing time. Compliance can also be increased by reminding the patient to use the removable appliance. This pilot study aims to investigate if any of two kinds of reminders objectively increase the compliance during orthodontic treatment with removable appliances or not.

MATERIALS AND METHODS: 18 patients between 9-14 years of age were selected from a patient population attending the department of Orthodontics, Faculty of Odontology, Malmö University. They presented different types of malocclusion which made them candidates for treatment with either van Beek-appliances or expansion plate. The patients were randomly placed in one of three groups; alarm, calendar or control group. Wearing time was objectively collected from the TheraMon®-module placed inside the acrylic base of the appliances. After the data collecting-phase was finished the data was tested with Anova and t-test to determine whether there was a significant difference between the groups.

RESULTS: The alarm group had the highest average wear time. The control group had slightly lower average wear time than the alarm group, and the calendar group had the least amount of average wear time. There was a difference in average wear time between van Beek and expansion plate, with van Beek having a lower average wear time than expansion plate. Patients treated with expansion plates were more cooperative than patients treated with van Beek appliances. When data was tested for significance, no statistical significance was found.

CONCLUSION: The study concludes that an alarm type of reminder appears to be better at improving wear time than a calendar or no reminder at all. This indicates that for future studies there might be a reason to develop a reminder for patients, for example an app. The study concludes that patients with expansion plates appear more cooperative than patients using van Beek appliance, so therefore focus should be on improving cooperation for patients using these types of appliances. This study shows that future studies should use one type of appliance, e.g. van Beek. More patients are needed in future studies to achieve statistical significant results.

Key words: Compliance, adherence, expansion plate, van Beek, alarm, calendar, orthodontics.

SAMMANFATTNING

INTRODUKTION OCH SYFTE: Tidigare studier av kooperation och ortodonti har visat att ett av de bästa sätten att öka patienternas kooperation är genom att övervaka användningstiden och påminna patienten om att använda sin apparatur. Den här pilotstudiens syfte var att undersöka om någon utav två olika typer av påminnelser objektivt ökar användningstiden vid behandling med avtagbar apparatur eller inte.

MATERIAL OCH METOD: 18 patienter i åldrarna 9-14 års ålder från en patientpopulation som behandlades vid avdelningen för Ortodonti, Odontologiska Fakulteten på Malmö Högskola, deltog i studien. Patienterna hade olika typer av bettavvikelser som gjorde dem behandlingsbara med antingen van Beek eller expansionsplåt. Patienterna placerades slumpmässigt in i en av tre grupper, alarm, kalender eller kontrollgrupp. Användningstid registrerades objektivt med en TheraMon®-timermodul som placerades inuti den ortodontiska apparaturens akrylbas.

RESULTAT: Alarm-gruppen hade högst genomsnittlig användningstid. Kontrollgruppen hade något lägre användningstid än alarmgrupppen och kalendergruppen hade minst genomsnittlig användningstid. Det var skillnad på de olika behandlingstyperna, då behandlade med expansionsplåt hade bättre genomsnittlig användningstid än patienter behandlade med van Beek. Data testades för statistisk signifikans med Anova och t-test, ingen statistisk signifikans fanns.

KONKLUSION: Den här studiens resultat tyder på att en påminnelse i form av ett alarm verkar vara bättre på att öka patienters kooperation än en kalender eller ingen påminnelse alls. Detta indikerar att det finns ett underlag för att i framtida studier vidare undersöka hur påminnelser via mobiltelefon påverkar compliance, till exempel påminnelse via en app. Patienter som behandlas med expansionsplåtar verkar ha en bättre compliance än patienter behandlade med van Beek- aktivatorer, därför bör framtida fokus läggas på att förbättra kooperationen hos patienter som behandlas med van Beek-aktivatorer. Framtida studier bör endast innefatta en typ av ortodontisk apparatur, till exempel van Beek. Fler patienter krävs i framtida studier för att säkerställa statistiskt signifikanta resultat.

Nyckelord: Compliance, kooperation, expansionsplåt, van Beek, alarm, kalender, avtagbar apparatur, ortodonti

Table of contents

Background ...... 1

1.1 The history of compliance ...... 1

1.2 Interceptive orthodontic treatment ...... 2

1.3 Earlier studies on compliance and orthodontics ...... 3

1.4 Technological advancements and compliance ...... 3

1.5 Aim ...... 4

Materials and methods ...... 4

2.1 Participants, groups and criteria ...... 4

2.2. Randomization ...... 5

2.3 Wearing rules ...... 6

2.4 TheraMon® and iButton® timer modules ...... 6

2.5 Evaluation of treatment ...... 8

2.6 Previous and current use of timer modules and technical considerations ...... 8

2.7 Ethical considerations ...... 9

2.8 Statistical analysis ...... 10

Results ...... 11

3.1 Patient process ...... 11

3.2 Main results, patient demographics and percentage wearing time ...... 12

3.3 Data analysis and description...... 12

3.4 Wearing time during first 65 days ...... 13

3.5 Wearing time during the last 30 days ...... 14

3.6 Comparison of wearing time between the first 65 and the last 30 days ...... 15

3.7 First 65 days of wearing, all groups ...... 15

3.8 Comparison, van Beek and expansion plate ...... 17

3.9 Gender differences ...... 18

3.10 Treatment results and average wear ...... 19

3.11 Comparison EOT and activator ...... 20

3.12 Subjective treatment opinions ...... 20

3.13 Statistical significance ...... 22

Discussion ...... 22

4.1 Main results ...... 22

4.2 Van Beek and expansion plate ...... 24

4.3 Active and passive reminders, wearing habits and gender ...... 25

4.4 Information about the study, of surveillance and potential benefits ...... 26

4.5 TheraMon® and iButton® ...... 27

4.6 Internal and external locus of control, treatment results and individual wearing time ...... 27

4.7 Improvements and subjects for future studies ...... 28

Conclusion ...... 30

References ...... 31

Appendix 1 ...... 34

Appendix 2 ...... 37

Appendix 3 ...... 38

Background

1.1 The history of compliance Getting patients to follow given advice is often a challenge for the dentist. Failure in patient compliance often leads to longer treatment time and more costly, complicated therapies.

Orthodontic treatment continues over a significant amount of time, and hence, good patient cooperation is essential for a successful treatment result. This type of cooperation is called compliance. The word compliance means to comply with a wish or command (1). It has been shown that it is possible to increase compliance when letting the patient use a calendar to monitor their own usage of removable orthodontic appliances (2). The times are changing, calendars and alarms can now be used in mobile phones and since the majority of children in

Sweden have access to a smartphone (3), this new technology might be used to further increase patient compliance in orthodontic treatments with removable appliances. The term “compliance” has evolved over time, and has come in multiple iterations as the view on health and the treatment of diseases has developed. From 1930 and up to 1974 came a period called the therapeutic period. In this period, the dentist delivered health to the patient, without any special consideration taken to the patient’s own lifestyle or oral hygiene. Patients were supposed to fully cooperate and only follow the advices the dentist gave, since the dentist was the expert on the patient’s own disease. However, a new definition of health gradually evolved called the new public health. Led by, among others, Lalonde (1974) and McKeown (1979), the definition of health changed foci from a general health care for all patients to an individually designed health care. Now, higher priority was given to how environmental factors were affecting patients, how the patients were living life and on human biology in general. (4)

1.2 Interceptive orthodontic treatment Interceptive orthodontic treatment aims to avoid development of malocclusion in the permanent dentition by treatment in the mixed dentition. The interceptive treatment is often conducted by the use of different kinds of removable appliances like activators with or without headgear, or expansion plates, affecting the growth of the jaw and the eruption of teeth. This type of treatment takes place over an extended period of time which places high demands on patient compliance and affects a big part of the patient’s regular life (5). Therefore it is important for the dentist to detect possible lapses in the compliance of the patients and correct them, before the treatment- window for removable appliance has closed. This usually occurs when the patient’s permanent teeth are fully erupted. If the patient chooses not to use the appliance according to given instructions, the treatment might take longer time, have less than optimal results and be more costly. It may also force the patient to receive further treatment with, for example, a fixed orthodontic appliance. (6) Therefore, it is of importance that the patient is following given directives.

Following directives can however pose somewhat of a problem, since children, when asked if they have used their headgear and/or appliance, usually answers that they have used their appliance according to instructions. This can happen even though the child might not have worn the appliance even remotely close to the prescribed time. The orthodontist is also prone to overestimate the wearing time, even though not quite as much as the patient. This makes it difficult to subjectively acquire a correct measure of the wearing time of the appliance, and thereby detect if the child needs more assistance and motivation to increase his or her compliance with given directives. (7,8)

1.3 Earlier studies on compliance and orthodontics In the past, much of the previous research revolving around compliance has focused on how to determine compliance before orthodontic treatment starts, so that patients with low compliance could receive more support to ensure successful treatment. However, no single reliable, validated method for determining compliance before treatment currently exists. As compliance and cooperation is a multidimensional concept it might therefore be difficult to find single factors that point out potential difficult patients before treatment start. (9-12) Today the focus lies on prevention and handling of non-compliant patients instead of determining who is a potential non- complier before treatment starts. It is possible to try to prevent non-cooperation. With a calendar as help to remind the patient of his/her braces, or a mobile alarm, it might be possible to increase these “non-compliers” compliance without knowing in forehand which patient will comply or not.

Previous studies show that engaging the parent in their respective treatment have had a positive effect on the child’s cooperation (2,9,11,13). With an everyday-reminder, the parents are also reminded of the appliance and should be able to encourage their child in using it according to the recommendations of the dentist.

1.4 Technological advancements and compliance In recent years, technology has made it possible to measure compliance objectively through the use of timer modules. Earlier research, for example by Bos et al (2007) and Tsomos et al (2014), has also shown that these objective measurements are preferable to subjective measurements, since subjective measurements tend to be inaccurate when determining compliance with removable appliances (7,14). There are multiple different modules out in the market today. Some

3 are attached to the appliance’s headgear traction module and begin measuring wearing time when the traction module is placed under tension (8), while others measure changes in temperature. Temperature-measuring models have in earlier studies been applied to the neckstrap of the headgear or molded to the acrylic base of the appliance (7,14). All of these modules are, after they have registered sufficient data, connected to a computer which then extracts the collected data (7,8,14). Because of removable appliances sensitivity to wearing time, it is of high importance that the patient complies with given instructions for a good treatment result. Earlier results has showed a positive correlation between wearing time of removable appliances and using a calendar (2). Nowadays, when children grow up in the digital world, it might be possible that a mobile alarm on the patients or the parents’ mobile phone, triggered on a specific time each day, can help the child to remember using his or her appliance the prescribed time. Similar systems have been used in earlier studies to good effect (15,16).

1.5 Aim The aim of this pilot study was to investigate if any of two kind of reminders increase the compliance during orthodontic treatment with removable appliances or not. Null-hypothesis was that the wearing time of removable orthodontic appliances would not increase with a calendar- or alarm-reminder and there would not be any differences between the groups.

Materials and methods

2.1 Participants, groups and criteria Eighteen patients, 11 boys and 7 girls between 9-14 years old from the Department of

Orthodontics, Faculty of Odontology, Malmö University were recruited to participate in this prospective randomized clinical trial. All patients were going to receive orthodontic treatment with one of two different types of removable appliances;

1) van Beek activator or 2) expansion plate.

To investigate which of the two different methods to increase compliance is the most effective, the participants were divided into three groups; group one received a reminder by the alarm function on their or their parents mobile phone, which sounded once a day at 19.00. Group two was equipped with a personalized conventional calendar (see appendix 3). Group three was a control group. The selection of patients was made consecutively, potential candidates were detected by students and teachers, and then informed about and asked to participate in the study.

The alarm signal was chosen by the patient/parent, while the name of the alarm was “Do not forget your appliance! :)”. In this study, inclusion criteria were healthy subjects prescribed with a removable appliance. The subjects’ parents would have access to a mobile phone with an alarm function. Exclusion criteria were children with physical or psychological disabilities. This was done due to the fact that children with disabilities could have more trouble with planning and decision-making concerning their own treatment, which could have affected the results of this

study.

2.2. Randomization Each patient was placed in a group through a random placement process. The initial goal was to include 30 patients in the study, therefore 10 rows with three columns in each were written down, the first one being the alarm group, the second one a reminder by calendar and the third was the control group. A six sided die was cast for each spot in the test. If it turned up number one or four, the person placed in that spot would go to the first group, if it turned up two or five, the second group, and if the die turned up three or six the person would be placed in the third group. Using this method, a list for the patients were created. When a patient decided to participate, they were placed in one of the three pre-randomized groups according to the earlier

5 created list. In this way, randomization of the patients was achieved. Gender was not part of the randomization process, due to earlier studies having shown that it does not appear to significantly affect compliance (7,12,14,17,18).

2.3 Wearing rules All patients were going to receive orthodontic treatment with one of two different types of removable appliances; 1) van Beek activator or 2) expansion plate. A van Beek activator with headgear is used 12-14 hours per day, mostly night-time, and is used to stimulate mandibular growth. An expansion plate is used for 22-24 hours a day to expand the upper jaw and/or protrude teeth. It is only to be removed when eating or tooth brushing. Van Beek activator is larger and extends extra orally which makes it more visible than the expansion plate which is placed solely intraorally (6).

2.4 TheraMon® and iButton® timer modules To be able to objectively assess difference in compliance when using two different types of reminders, each patients wearing time was registered by a timer module that was molded into the acrylic base of the appliance (TheraMon®, Gschladt Company, Hargelsberg, Austria).

Figure 1.1: TheraMon ® timer module (left) and the module molded to the acrylic base of a van Beek activator

(right).

The data was processed by additional software from TheraMon® (TheraMon Viewer®) by wirelessly transferring the data from the molded TheraMon® timer to a computer, using the

TheraMon® registration stations.

Figure 1.2: The TheraMon® Registration station, attached to a computer, with its attached software running.

After the data was retrieved from the timer module, clinical records were searched to investigate if the objectively registered wearing time had any correlation with changes in horizontal and vertical overjet. In addition, to investigate the correlation between headgear-use and activator use, a timer module, Thermocron iButton® (DS1921G-F5#, Maxim integrated, San Jose, CA,

U.S), also registered the wearing time of the headgear of 4 of the patients with van Beek- activator, to verify if the headgear was used together with the activator.

Figure 2.1: The iButton® timer (left), and the same timer sewn to the headgear (right).

Software to recover the data from the iButton® was produced by Maxim Integrated (1-wire®

Viewer). The timer modules detect changes in temperature, thus recording the time of use of the appliances. (7,14)

Figure 2.2: The BlueDot® receptor for the iButton® (left), and the BlueDot® receptor connected to a computer with its attached software running (right).

2.5 Evaluation of treatment The treatment effect was evaluated by collecting data on changes in sagittal and vertical dimensions from the patient’s journal. To assess any correlation between treatment effects and wearing time of the van Beek patients, collected data from the patients’ journal was compared.

When the study was finished, the participants and their parent were asked three questions:

1. How has the appliance and wearing of appliance worked?

2. How has the reminder worked?

3. If you did not use your appliance, what was the reason for not using it?

This was done to receive a subjective opinion from parent and child about how the reminder and the treatment worked out, as well as to evaluate the placement of the timer modules. It was also done to compare the reminders against each other and maybe find some consensus concerning the differences between alarm and calendar. The use of van Beek and expansion plate appliances was also compared, to find eventual subjective positive and negative opinions of the two.

2.6 Previous and current use of timer modules and technical considerations TheraMon® and iButton® have both been used in earlier studies (7,9,14,19,20). The

TheraMon® devices was in this study used in both expansion plate and van Beek activator

8 treatment, while the iButton® was just used in some treatments with van Beek appliances, since the device had to be fastened to the external headgear of the activator. This extra measurement by the iButton® was made to compare the wearing time between the two modules and to be able to asses if the patient used the headgear together with the activator. It was also done to test their respective hardware and software for potential use in future studies. TheraMon® is first activated by the technician before it is molded to the appliance. Then, when it arrives to the dentist, it is assigned to a patient with a specific number or name and its measuring is initiated. TheraMon® detect changes in surrounding temperature every 15th minute. The timer module data from

TheraMon® is recovered each time a patient is on a scheduled appointment by connecting it wirelessly to a computer, using the TheraMon® reading station (21). iButton® is activated using the 1-Wire driver® software, and its registration was set to once every 20th minute. It was thereafter sewn to the headgear, covered by a cloth patch and cotton to increase patient comfort.

When the data collection was completed, the timer module was removed from the headgear and slotted into a BlueDot® receptor. Then the data was transferred to a computer, once again using the 1-wire® software. (22)

2.7 Ethical considerations An ethical review, reference-number OD 2013/314-59, was submitted 2013-10-24 to the ethics committee of the Faculty of Odontology at Malmö University, and was approved. The patients and their parents were informed of the research plan, the methods that were going to be used and the benefits and possible risks of participation. If they then wanted to participate in the study, the parent had to give their written consent (see appendix 2). It was also important to make the patient aware of who was supervising the project and to acquire his or her informed consent.

Even though a child has a limited autonomy and his or her legal guardian must approve the

9 participation, the child was always given the opportunity to make an informed decision about whether it wanted to participate in the study or not. The child could at any time discontinue its participation, even though its legal guardian has given consent to take part in the research project. To conduct this research, the cost and benefits for society of the study had to be evaluated beforehand, and was is important that the benefit outweighed the eventual risks for the participants (23). Patients and their legal guardians were informed about the study beforehand by reading a statement of intent (see appendix 1), and by being able to ask questions to a contact person responsible for the study. They also received an information blanket, containing all necessary information in accordance with Swedish law. Information about the surveillance of the wearing time of the appliance was also given, as it was deemed unethical to exclude this information from the participants. (23)

2.8 Statistical analysis The program used to analyze data was IBM SPSS Statistics v 22, and Microsoft Excel 2013 was used for diagrams and charts. Mean, standard deviation and average values were calculated and compared between the groups

Results

3.1 Patient process

In total, 18 patients in the age of 9-14 years accepted to participate in the study in the months of

April until October, 2014. During the course of the study, two were removed from the study by their own request. One patient was excluded because of technical failure of the timer module, and one patient had to be excluded because of time restraints. In total, 14 patients were included

Patients awaiting treatment with removable appliances agreeing to participate in study; n=18

Patients removed from study by own request; n=2

Patients in treatment with removable appliance, n=16

Patient removed Patient removed from stuy due to time from stuy due to restraints: technical failure: n=1 (control group) n=1 (alarm group)

Patients in Alarm Patients in Calendar group; n=4 Patients in Control group; n=5 group; n=5

11 in the final result. The process is shown in Flow Chart 1.

Flow chart 1: Patient selection process.

3.2 Main results, patient demographics and percentage wearing time The main results of this study were that group one, the alarm-group, has the highest wearing time percentage of the three groups with 86.3%. Group two, the conventional calendar, has the lowest with 43.6% and group three, the control-group, have its values slightly under the alarm-group with 74.2%.

Table 1. Demographic and clinical characteristics of patients.

TOTAL PATIENTS ALARM CALENDAR CONTROL (N=18)* (N=4) (N=5)** (N=5) Mean or N SD Mean or N SD Mean or N SD Mean or N SD Demographic characteristics Age (years) 11.5 ± 1.20 11.5 ± 1 11.5 ± 0,894 11.5 ± 1.48 9 boys 3 boys 2 boys Gender 4 boys 5 girls 2 girls 3 girls

Type of 8 van Beek 2 van Beek 4 van Beek 2 van Beek appliance 6 exp. plate 2 exp. plate 1 exp. plate 3 exp. plate * Four patients dropped out of the study. ** One patient used both van Beek and expansion-plate.

To be able to compare van Beek and expansion plate, the wearing time in this study is presented in percentage, with 100% being 12 hours worn per day for van Beek and 22 hours worn per day for expansion plate. Since patients at times wore the appliance more than 12 or 22 hours, the maximum wearing time sometimes stretches above 100%.

3.3 Data analysis and description

The data for the first 65 days were analyzed and presented in diagram 4.2. This dataset was chosen because it was the maximum amount of days that was registered for all patients, since the start of treatment differed, from May 2014 to October the same year. Some patients had registered data for over 160 days, while others only had about 68 days. The last 30 days were also compared since previous studies have shown that compliance decreases over time (7,11).

However, this data was not statistically analyzed, since the days registered differed between patients, and therefore the last 30 days for one patient could be after 90 days of treatment, while for another, they could be after only 60 days of treatment. The collected wearing time for all patients in the study is shown in figure 4.1.

TOTAL REGISTERED AMOUNT OF WEARING TIME 14 13 12 11 10 9 8 7

PATIENTS 6 5 4 3 2 1 0 50 100 150 200 NUMBER OF DAYS

Figure 4.1 Total registered wearing time for all patients in study.

3.4 Wearing time during first 65 days During the first 65 days, the alarm and control group has the highest wearing percentage. The difference between the two groups was 12 % with an advantage in wearing percentage in the alarm group. Further down, with less wearing percentage, was the calendar group with 43.6 %.

The distribution of the three groups is shown in Figure 4.2. On the vertical axis is the wear time in percent with 100 % as 12 hours for van Beek-appliances and 22 hours for expansion plate, on

13 the horizontal axis is the number of days of surveillance. The yellow curve shows the average wearing time for the alarm group day by day, hence the fluctuation in correlation to the time axis. The yellow straight dotted line shows the total average (86.3 %) for all the 65 days at once, this means that the average patient in this group uses his/her appliance 86.3% of the recommended usage time.

The blue curve shows the average wearing time for the control group day by day. The blue straight dotted line depicts the total average of 74.2 % of 100 % usage each day, which is slightly under the alarm group. The gray curve, which is below the other groups, shows the average wearing time of the calendar group each day and as an average, the gray dotted line, at 43.6%.

FIRST 65 DAYS Alarm Calendar Control Average alarm 86.3% 120% Average calendar 43.6% Average control 74.2%

100%

80%

60% WEAR % WEAR 40%

20%

0% 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61 63 65 NUMBER OF DAYS Figure 4.2. Comparison between the 3 groups during the first 65 days of treatment.

3.5 Wearing time during the last 30 days When comparing the last 30 days of measurement, the alarm group has the highest rate of compliance with an average wear time of 88 %, followed by the control group with an average wear time of 64, 6 %. The calendar group had an average wear time of 37, 5 %. Wear time day by day and average wear time for 30 days is shown in Figure 4.3.

LAST 30 DAYS Alarm Calendar Control Average alarm 88 % Average calendar 37.5% Average control 64.6% 100%

80%

60%

WEAR % WEAR 40%

20%

0% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 NUMBER OF DAYS Figure 4.3. Comparison between the three groups during the last 30 days of each individual measurement.

3.6 Comparison of wearing time between the first 65 and the last 30 days When comparing wear time between the first 65 days in Figure 4.2 and the last 30 days in Figure

4.3, a greater difference between the alarm group and the control group can be seen in the last 30 days. The calendar group has the lowest amount of wearing time in both diagrams, only overlapping the control group in a few instances.

When looking at the alarm group in the last 30 days of treatment, the patients wear time is consequently around 88 %, compared to the first 65 days of wear when the curve was fluctuating more, the average wear was also 2 % less. A general drop of wear time percentage can be seen in the last 30 days of measuring for the calendar and control group with 6 and 10 % drop respectively.

3.7 First 65 days of wearing, all groups Figure 4.4 depicts the wearing curve of each individual patient from the alarm group day by day.

The red dotted line indicates the average wearing percentage of 86.3 % for all the patients together. In this diagram, it is possible to follow each patient and his or her wearing habits. For

15 example at day 55, “Patient 1” (the purple line), drops down to 0%, which indicates that the patient did not use his/her appliance at all this day. However, in this group overall, the wearing habits are quite constant with frequent wearing.

ALARM GROUP, FIRST 65 DAYS Patient 1 Patient 2 Patient 3 Patient 4 Average; 86,3 %

100%

WEAR % WEAR 50%

0% 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 NUMBER OF DAYS Figure 4.4. Each percentage wear of individual patients during 65 days for the alarm group.

When looking at the calendar group in the first 65 days of treatment, three patients consequently wore their appliance more often than the average of the whole group. Patient 3 had an average wearing time of 2, 8 %, the lowest in the group and in the whole study. Worth noting was that one patient had to switch appliances after 21 days of treatment (Patient 6). All individual and average data for the calendar group is shown in Figure 4.5.

CALENDAR GROUP FIRST 65 DAYS Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 * Average 41,4%

120%

100%

80%

60% WEAR % WEAR 40% 20% 0% 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 NUMBER OF DAYS Figure 4.5. Each percentage wear of individual patients during 65 days for the calendar group.

In Figure 4.6, individual measuring times are presented for the control group. The red dotted line indicates the average wearing time for the whole group at 74.2%. The wearing habits of this group are irregular, which indicates that the usage has not been stable day by day.

CONTROL GROUP FIRST 65 DAYS Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Average; 74,2 % 120% 100%

80%

60% WEAR % WEAR 40% 20% 0% 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 NUMBER OF DAYS Figure 4.6. Each percentage wear of individual patients during 65 days for the control group.

3.8 Comparison, van Beek and expansion plate The results of this study indicates that patients with expansion plate used their appliance more than van Beek users when measuring percentage of total wearing time. The expansion plate had an average wear time of 80.8% and the van Beek-appliance had an average wear time of 57.5%.

In Figure 4.7 the average wear time percentage for expansion plates and van Beek –appliances is shown with wearing percentage on the vertical axis and time on the horizontal axis. The blue curve is the wearing time for expansion plate fluctuating day by day. The dotted blue line is the average wear percentage for expansion plates, 80.8 %. The van Beek-appliance has its wearing time shown by the yellow curve, day by day. The dotted yellow line is the average wear percentage for the van Beek-appliance, 57.5%. There was also a difference in wear time between van Beek and expansion plate, where the van Beek-appliance has the least wear percentage of the two.

COMPARISON AVERAGE WEAR VAN BEEK AND EXPANSION PLATE FOR THE FIRST 65 DAYS Van Beek Expansion plate Average van Beek 57.5% Average expansion plate 80.8% 100%

80%

60%

40% WEAR % WEAR

20%

0% 1 4 7 10 13 16 19 22 25 28 31 34 37 40 43 46 49 52 55 58 61 64 NUMBER OF DAYS Figure 4.7. Comparison of average wear between the two appliances, expansion plate and van Beek.

3.9 Gender differences When comparing usage time between genders the boys had a slightly greater wearing average at

67.1%, see the red curve. Girls, the blue curve, had an average wearing time of 63.8%. The difference between the groups was 3.3%. This can be seen in Figure 4.8.

DIFFERENCES OF GENDER Girls Boys 100% Girls average 63.8% Boys average 67.1%

80%

60%

40% WEAR % WEAR

20%

0% 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57 59 61 63 65 NUMBER OF DAYS

Figure 4.8 Comparison between genders.

3.10 Treatment results and average wear A comparison between the average wear time of the van Beek appliances and the resulting change in occlusion was made. This was done for all the van Beek-appliances, the patient with the greatest average wear time also had the largest change in occlusion, -5, 5 mm overjet, -3 mm overbite. However, patients that had a lot less average wear time, for example patient five and patient six, also had some changes in occlusion, patient six, -1, 5 mm overjet, -1 overbite. The two patients in the alarm group both had high wear percentage, 81,0 % and 95,5 % wear time, the patients in the calendar group varied a bit and had both high, 87,8 % wear time, and low,

1,8% wear time, compliers. This data can be seen in Table 2.

Number of Resulting change in occlusion Average wear days in Group Patient time (% or hours) treatment Overjet Overbite Alarm 1 81.0 % 9.7h 155 - 5 mm - 2,5 mm

Alarm 3 95.5 % 11.4h 117 - 5,5 mm - 2,5

Calendar 5 22.3 % 2,7h 191 - 2,5 mm -3 mm

Calendar 6 12.4 % 1.5h 181 - 1,5 mm - 1 mm

Calendar 7 1.8 % 0.21h 108 - 2 mm 0 mm

Calendar 8 87.8 % 10.5h 82 - 3 mm + 0.5 mm

Calendar 9 78 % 9.3h 188 - 5.5 mm - 1 mm

Control 12 53.4 % 6.4h 187 - 3 mm - 2 mm

Control 13 82.9 % 9.9h 161 - 3.5 mm - 1 mm

Table 2. Wear time and resulting change in occlusion.

3.11 Comparison EOT and activator When comparing the wearing time of the EOT (measured with iButton®) and the wearing time of the appliance (measured with TheraMon®), it is clear that the four patients have worn their

EOT together with their appliance. Still, the two systems differ in hours measured, the greatest difference being 95 hours (patient 3). This comparison between wearing time of appliance and

EOT is shown in Figure 4.9.

Figure 4.9 Comparison EOT wear and appliance wear.

3.12 Subjective treatment opinions After the measurements were concluded, the parent and child were asked three questions about the treatment to give a subjective opinion about the potential use of reminders and the use of removable appliances as a whole.

1. “How did the treatment work?“

2. “How did the reminder work?”

3. “If you did not use the appliance in one instance, why?”

This can be seen in Table 3.

Questions asked to patients “How did the “How did the “If you did not use Group Patient treatment reminder the appliance in one work?” work?” instance, why?” The patient forgot it when Good. A little hard to Alarm 1 Good. travelling to his mother or speak while using it. father who lived separately. Parents reminded their child when the The patient has always used Alarm 2 Good. alarm rang, worked it. good. Alarm 3 Good. Good. Because of pain. Quite good. A little Good. A little irritating Because of fatigue, which irritating at night, hard Alarm 4 if the expansion plate made the patient forget to to talk when using was already in use. use it. expansion plate 2-3 days had been filled in, the rest had been forgotten. They Forgot it, for example when Good, ”Used it (the Calendar 5 failed to bring it with the patient had sleep-overs appliance) every night” them to the final with a friend. appointment with the dentist. Was good initially, after a while it became Because of pain, difficult to Has worked tedious and the breathe and different Calendar 6 sometimes. mother was tired of activities e.g. football, playing nagging about it to her the trumpet. child. So-so. The patient It is not so problematic forgot to record his Because the patient was tired Calendar 7 anymore… [as it was wearing time quite and forgot to use it. early in the treatment]. often. Has worked well, but Forgot to use it a few times Calendar 8 Good. doesn’t want a new when the patient was cozy one. with her mom. Had for a time pain because Has not use the of decubitus caused by the Calendar 9 Good. calendar so much. appliance, which hindered usage. When using the expansion plate every day it was easier to remember than when they Good. Sometimes a changed to using it every Control 10 Not applicable. small lisp. other day (retention phase). No one reminded them to put it on so they forgot it more often. The treatment has Because the patient Control 11 Not applicable. worked well. sometimes forgot about it. Good, but the appliance sometimes Because the patient forgot Control 12 Not applicable. falls out of the mouth about it. during night-time. Had a pyogenic granuloma which has caused pain, Control 13 Has worked well. Not applicable. therefore didn’t use appliance from time to time because of pain. If the patient didn’t use it was Control 14 Good. Not applicable. because he forgot, or was exercising. Table 3: Oral responses by patients and parents concerning their treatment and the use of reminders.

A calendar was sometimes forgotten by the patient and parent or was not used at all and parents might have reminded their child when the alarm rang on their mobile phone. Some reasons for not using the appliance was because of pain or because it was forgotten when the child was sleeping at a friend’s house. The responses and the respective questions are shown in Table 3.

3.13 Statistical significance To verify the results, statistical analysis was conducted on two different sets of data. A p value less or equal to 0,05 was deemed as significant. The average wear time for the first 65 days compared between the three groups (p=0,171) and the comparison between expansion plate and van Beek for the first 65 days (p=0,209) was analyzed using nested Anova and t-test respectively. This method was chosen by the statistician due to the relative few number of participants in each group.

Discussion

4.1 Main results The null hypothesis of this randomized controlled pilot study was that there would be no difference between the three groups involved after 65 days of treatment. The results of this study indicate that a reminder with an alarm that goes off once per day at 7 pm can increase compliance more than a calendar. However, the number of patients in this study were too few to acquire a significant enough power to reject the null hypothesis. To acquire significant results and to make a study with sufficient power, more patients will be required in future studies. The results showed that there was no statistical significant difference between the three groups in the first 65 days of wear. There was also no statistical significant difference between the average wear time of van Beek and expansion plate. Nevertheless, the results from this study shows

22 tendencies towards an improvement in compliance and wearing habits in the alarm group.

There are differences in wearing habits that the authors find interesting between the first 65 days and the last 30 days. The alarm group seems to have a greater stability in wearing with less drops in compliance. This could be because the alarm actively reminded the patient each day. The wearing modus of the control group became much more fluctuating and the average wear was lower in the later stages of measuring. This is usually the normal wearing behavior of patients when treated over extended periods of time. The results of this study appear to be conclusive with earlier studies showing that compliance decreases with time, as with the control and calendar group. (7,11,13) The alarm appears to be specific in the way that the wearing time increased during course of time in the alarm group. In the calendar group, some patients had high compliance and some patients had low compliance, with large individual differences. This could be a result of differences in Locus of Control, the calendar being a passive reminder and if disliked, it was easily ignored.

The results of this pilot study indicates that the alarm type of reminder has worked sufficiently for a larger study to be conducted. When the participants were asked subjectively about the alarm the bigger part of them were positive about it and said that it had worked well. However, for the conventional calendar, the results showed the opposite and most of the patients were more negatively inclined. This could potentially be a result of the calendars design, since it was large and could be seen as a bit cumbersome for the patient to bring with them. Other studies have, when investigating objective compliance with removable appliances, acquired median wearing percentage of 83,3%, 67,5%, 69,2% and 75,0% of optimal wear time. Therefore, even though this study is a pilot study, the results acquired from the control group, which was 74,2%, are

23 conclusive with earlier research. (14,24-26)

4.2 Van Beek and expansion plate One source of error in this study was that, to acquire sufficient patients for a pilot study, patients that were treated with expansion plates as well as van Beek appliance had to be incorporated.

This was due to the number of patients treated with van Beek-appliances at the Department of

Orthodontics, Faculty of Odontology, Malmö University being low, and more patients were deemed necessary to acquire results. Since the two appliances differ in recommended wearing time and usage, including both might have affected the result of this study. This theory is strengthened by the comparison in wearing time between van Beek and expansion plate, where expansion plate had a higher average wear time compared to van Beek over the first 65 days.

Also, earlier studies on the subject of compliance have investigated compliance and, specifically, van Beek-appliances (7,14), indicating that these appliances might be more compliance reliant than expansion plates.

The difference in wearing time percentage when comparing expansion plate and van Beek- appliance shows that expansion plate has a higher wear time than van Beek, indicating that the expansion plate is easier for the patient to use. This could be because of the different modalities of the appliances, one is solely used internally and the patient can talk quite freely, although sometimes there is a lisp. The van Beek is larger and has an external part and also hinders the patient’s ability to talk because they have to have their mouth closed during wearing.

In conclusion the van Beek-appliances appears to restrict the patient life more than the expansion plates which probably is the reason for their different average wear time. Worth noting is that in the calendar group, most of the patients were treated with van Beek appliance. In hindsight, each type of the two appliances used in this study should have had their respective randomization.

This would have enabled a more equal distribution of appliances between the three groups. Since the two appliances differ in more ways than the recommended usage time, it should be appropriate to include patients receiving similar treatment in future studies of this subject.

4.3 Active and passive reminders, wearing habits and gender One difference between the two reminders is that the calendar is an “active” reminder and the alarm is a “passive” reminder. In the calendar-group the patient or parent must actively fill in the calendar every day, which in one case resulted in extra load and a feeling of guilt for the parent when the treatment did not reach the expected result. This could also potentially result in an aversion of going to the dentist, because of the feelings of guilt and shame if the patient had used its appliance over too little time. The mobile alarm works as a passive reminder to the patient.

The parent or patient does not have to work or apply themselves, the reminder is given to them and there is no extra load above the wearing of the appliance. Previous research shows that individuals today have a greater preference for procrastination than in the past. This could be an effect of today’s society, since there are more desirable activities competing for attention today than in the past, for example playing games or internet messaging which is readily available (27).

Therefore, a “chore” as manually filling in a calendar might pose too much work for the patient and parent, and the calendar might therefore often be discarded or simply filled in afterwards just before the visit to the dentist. This can lead to preference for the more user friendly mobile alarm, a concept which can be developed to perhaps a mobile app which is solely designed for children with fast rewards, incorporated in a child's everyday life in a digital world. This could be a more promising way of reminding children today. For many kids, traditional education now seems too slow in this digital age (28). Therefore the conventional calendar might be more likely to fail in helping kids because of its “old” medium (29). In this study, gender did not appear to

25 have affected the compliance of the patients in any significant way. This is in line with other studies that have investigated the subject (7,9,11,12,30).

4.4 Information about the study, of surveillance and potential benefits Before the experiment began the participants were informed that their wearing time was going to be registered, even though this has shown to have a potential impact on compliance. This was done due to ethical reasons. They were, however, not informed about the appliance registration of the thermal variations in its surroundings. Hence the patients would not “cheat” and try to enhance their wearing time by, for example, laying their appliance on a radiator. Still, this information could have affected the wearing time in this experiment, as surveillance in previous research have been shown to be one of the largest factors improving compliance. (9,11,31)

The subject of surveillance is an ambivalent question. It might be good for the patient and parent to see wearing time in a concrete way in form of a diagram since wearing time can normally be an abstract expression and hard to grasp. It is often overvalued by both the treating dentist and parent/patient (7). In another view it could be intrusive in the patients’ private life. Pros and cons with surveillance must be valued individually. In some cases with poor compliance in conjunction with a timer module, the dentist has the option to make an intervention with the patient and also decide if the treatment should be dismissed entirely. This could save unnecessary treatment time with a removable appliance and result in saved resources for society, since the patients unsuccessful treatment with removable appliance could be stopped in time and later replaced with a bonded orthodontic appliance instead.

Taking part in this study could have brought benefits to the participants, one of them being that parents may have got more involved in the child's treatment. Earlier studies have showed that when parents are participating and supporting the child during treatment the compliance of the

26 child increases (2,13,32).

4.5 TheraMon® and iButton® In this study, two different systems were used to measure compliance in an objective way,

TheraMon® and iButton®. However, iButton was only used to see if the patient used headgear together with the activator. The measurements retrieved from the different systems were largely the same, though some differences in registered wearing time were noticed. These differences were probably a result of the placement of the timer module, inside the appliance (TheraMon®) and outside on the neck strap (iButton®). The two systems also had different measuring intervals, 15 minutes for Theramon® and 20 minutes for iButton®. The iButton® fastened to the headgear did in one instance result in discomfort during wear, and the patient felt relieved when it was removed from the headgear. This discomfort might have resulted in a decrease of wearing time, thus affecting the total hours worn of the appliance. All in all, it seems that the patients use their headgear together with their activators which is good, as activators without headgear have a tendency to fall out of the mouth during sleep.

Worth noting is the potential environmental effect of appliances with timer modules, since they consist of a battery and different metallic parts, they have to be properly taken care of after use.

There are no registered cases of allergic reactions to the modules used in this study, however, the risk is always present and should be considered, even though it is very low but still greater than zero. Theramon® is fully RoHS-compliant and does not emit any radiation during use, while the iButton® is fully RoHS-compliant with an exception for contained lead (33).

4.6 Internal and external locus of control, treatment results and individual wearing time After discussion about how the treatment has gone with the participants it seems that most patients with good compliance had an own sense of responsibility over the treatment and

27 reminder, while the patients with poorer compliance had pushed the responsibility for the treatment over to his/her parent. One example of a patient with good cooperation had a special rule for filling in the calendar that she was very decisive about, and she would absolutely not let her mother fill it in for her because it would then be done in the wrong way. Another compliant patient´s parent said that his child handled everything about the appliance and reminder himself without the help of anyone else in the family. Many of the parents of non-cooperative patients appeared to have taken over almost all responsibility for the child. This indicates that if the patient have a more intern locus of control the compliance increases and the opposite might happen to patients with a more external locus of control. This has been seen in other studies (34).

When comparing wearing time to resulting changes in occlusion, it is difficult to see any patterns or common nominators between treatment result, change in occlusion and wearing percentage, due to too few patients in this study. One thing that is clear is that all patients who had a change in horizontal overjet above 5 mm had a wearing percentage around or above 80 %. However, it seems that some patients have received quite a big change in overjet even though they had a low average wearing time. This could be because they initially might not have worn the appliances at all because of pain or bad fit, and then later, started to wear them a lot more (pat 5). Some changes in overjet and overbite might also be attributed to normal growth (pat 6 and 7), since the patients average wearing time was below 13% of the prescribed time. Differences in wearing time and change in occlusion can be attributed to many things, like age, grade of malocclusion, et cetera (6).

4.7 Improvements and subjects for future studies A source of error was that the information given to the patients concerning reminders was also performed by different people, something that affected the quality of the study and similarity of

28 information given to patients. Every dental student responsible for informing patients and their parents about the reminders and the study had been given the same prior instructions. Still, the use of multiple people as information givers did in a few instances result in confusion for the patients and, in one case, a partly erroneous implementation or an initial removal of reminders by the patient and parent. This was corrected, nevertheless, this should be avoided in future studies.

TheraMon® did in some instances pose a challenge to dental technician in this study, since it has to be molded to the acrylic base, and could sometimes make the acryl bulky. This was primarily a problem when used with an expansion plate, since these appliances have less of an acrylic bulk than van Beek appliances, and more wires that had to be taken into consideration. The time taken to install the timer module by the dental technician into the appliance was not deemed to affect the production time of the appliance in a significant way. However, if the technician also had to activate the device digitally, there might be an extra cost for the time spent that has to be taken into consideration for future, larger use of timer modules.

For future research, the wearing time of removable appliances correlating to the changes in occlusion should be evaluated to see if the recommended wearing time is appropriate, or should be lessened or increased. Also, mobile phones and portable devices like data pads could be incorporated and used for reminding patients to use their appliances in future studies. In the clinical situation, this could be a cost-effective way to increase the wearing time of the appliance and thereby shorten the time taken for successful treatment. Eventually, this would reduce the cost for both the individual and for society as a whole. The alarm function could also be beneficial for other areas within the dental profession. Compliance registration systems like

TheraMon® could be used to objectively register wearing habits in future studies.

Conclusion

 This study indicates that a mobile alarm can improve patient compliance over time in treatment with a van Beek-appliance or expansion plate. A calendar did not seem to improve compliance. However, the results must be interpreted with caution because of too few enrolled patients.

 The greatest part of the participants in the alarm group was positively inclined about the reminder. In the calendar group it was the opposite. This is conceivably favorable for the future use of electrical reminders.

 With the information that was concluded in this study it is possible to see the benefits of an app with rewards that is similar to a game, which could improve compliance for children with removable appliances.

 This study indicates that using an expansion plate was easier than wearing the van Beek- appliance. This suggests that more resources on enhancing compliance should be directed towards treatments with van Beek-activators. To investigate compliance with removable appliances in the future, only one type of appliance, van Beek, should be included to reduce the source of error.

 Even though this is a pilot study, the average wearing time acquired from the control group is conclusive with earlier research on the same subject.

 Compliance registration systems like TheraMon® could be used to objectively register wearing habits in future studies.

Acknowledgements: The authors would like to thank Dental technician Jan-Erik Persson, Dr. Björn Ludwig and Dr. Anniemieke Bos for their advice concerning compliance-monitoring. We would also like to thank TheraMon® and Ing. Gerhard Gschladt for supplying materials for this study and Per-Erik Isberg for the statistical analysis.

References

(1) - Oxford Dictionaries. - "compliance". Available at: http://www.oxforddictionaries.com/definition/english/compliance. Accessed 02/04, 2015.

(2) Cureton SL, Regennitter FJ, Yancey JM. The role of the headgear calendar in headgear compliance. Am J Orthod Dentofacial Orthop 1993;104:387-394.

(3) Findahl O. Svenskarna och Internet. 2012 Avaliable at http://www.soi2014.se/. Accessed 27/04, 2015

(4) Surgeon General. Oral health in America: a report of the Surgeon General. 2000; Available at: http://www.nidcr.nih.gov/DataStatistics/SurgeonGeneral/sgr/chap10.htm. Accessed 02/09, 2015.

(5) World Health Organization. Adherence to Long-term Therapies : Evidence for Action. 2003.

(6) Bishara SE. Textbook of orthodontics. London: Saunders; 2001.

(7) Bos A, Kleverlaan CJ, Hoogstraten J, Prahl-Andersen B, Kuitert R. Comparing subjective and objective measures of headgear compliance. Am J Orthod Dentofacial Orthop 2007;132:801- 805.

(8) Cole WA. Accuracy of patient reporting as an indication of headgear compliance. Am J Orthod Dentofacial Orthop 2002;121:419-423.

(9) Bos A, Hoogstraten J, Prahl-Andersen B. The theory of reasoned action and patient compliance during orthodontic treatment. Community Dent Oral Epidemiol 2005;33:419-426.

(10) Clemmer EJ, Hayes EW. Patient cooperation in wearing orthodontic headgear. Am J Orthod 1979;75:517-524.

(11) Bartsch A, Witt E, Sahm G, Schneider S. Correlates of objective patient compliance with removable appliance wear. Am J Orthod Dentofacial Orthop 1993;104:378-386.

(12) Sergl HG, Zentner A. Predicting patient compliance in orthodontic treatment. Semin Orthod 2000;6:231-236.

(13) Albino J, Lawrence S, Lopes C, Nash L, Tedesco L. Cooperation of adolescents in orthodontic treatment. J Behav Med 1991;14:53-70.

(14) Tsomos G, Ludwig B, Grossen J, Pazera P, Gkantidis N. Objective assessment of patient compliance with removable orthodontic appliances: A cross-sectional cohort study. Angle Orthod 2014;84:56-61.

(15) Roth JP, Kula Jr TJ, Glaros A, Kula K. Effect of a computer-generated telephone reminder system on appointment attendance. Semin Orthod 2004;10:190-193.

(16) Dr J. Foley, M. O’Neill. Use of Mobile Telephone Short Message Service (SMS) as a Reminder: the Effect on Patient Attendance. Eu Arch Paed Dent Volume 2009;10:15-18.

(17) Richter DD, Nanda RS, Sinha PK, Smith DW, Currier GF. Effect of behavior modification on patient compliance in orthodontics. Angle Orthod 1998;68:123-32.

(18) Bos A, Hoogstraten J, Prahl-Andersen B. Towards a comprehensive model for the study of compliance in orthodontics. Eu J Orthod 2005;27:296-301.

(19) Ackerman MB, McRae MS, Longley WH. Microsensor technology to help monitor removable appliance wear. Am J Orthod Dentofacial Orthop 2014;135:549-551.

(20) Schott TC, Schrey S, Walter J, Glasl BA, Ludwig B. Questionnaire study of electronic wear-time tracking as experienced by patients and parents during treatment with removable orthodontic appliances. J Orofacial Orthop 2013;74:217-225.

(21) Handelsagentur Gschladt. TheraMon® microsensor. Available at: http://www.english.theramon.com/the-product/transponder/index.html. Accessed 03/17, 2014.

(22) Maxim Integrated. Thermochron iButton Device, DS1921G. Available at: http://datasheets.maximintegrated.com/en/ds/DS1921G.pdf. Accessed 09/16, 2013.

(23) Regeringskansliet / Lagrummet. Lag (2003:460) om etikprövning av forskning som avser människor. Available at: http://www.riksdagen.se/sv/Dokument- Lagar/Lagar/Svenskforfattningssamling/Lag-2003460-om-etikprovning_sfs-2003-460/. Accessed 08/11, 2014.

(24) Schäfer K, Ludwig B, Meyer-Gutknecht H, Schott TC. Quantifying patient adherence during active orthodontic treatment with removable appliances using microelectronic wear-time documentation. Eu J Orthod 2015;7:73-80.

(25) Pauls A, Nienkemper M, Panayotidis A, Wilmes B, Drescher D. Effects of wear time recording on the patient's compliance. Angle Orthod 2014;83:1002-1008.

(26) Kawala B, Antoszewska J, Sarul M, Kozanecka A. Application of microsensors to measure real wear time of removable orthodontic appliances. J Stomat 2013;66:321–330.

(27) Steel P. The nature of procrastination: A meta-analytic and theoretical review of quintessential self-regulatory failure. Psychol Bull 2007;133:65-94.

(28) Levine LE, Waite BM. Television viewing and attentional abilities in fourth and fifth grade children. J Applied Develop Psych 2000;21:667-679.

(29) United Nations. Young people in a globalising world. 2003; Available at: http://www.un.org/esa/socdev/unyin/documents/ch11.pdf. Accessed 02/03, 2015.

(30) Ağar U, Doruk C, Biçakçi AA, Büküşoğlu N. The role of psycho-social factors in headgear compliance. Eu J Orthod 2005;27:263-267.

(31) Doruk C, Agar U, Babacan H. The role of the headgear timer in extraoral co-operation. Eu J Orthod 2004;26:289-291.

(32) Cucalon A, Smith RJ. Relationship between compliance by adolescent orthodontic patients and performance on psychological tests. Angle Orthod 1990;60:107-114.

(33) Lead-free/ROHS products and content data. 2015; Available at: http://www.maximintegrated.com/en/emmi/content_lookup.cfm?Ac=S&PN=DS1921G- F5%23&Pkg=IB%235CP&Pbf=0&ID=1057097. Accessed 02/11, 2015.

(34) Eppright M, Shroff B, Best AM, Barcoma E, Lindauer SJ. Influence of active reminders on oral hygiene compliance in orthodontic patients. Angle Orthod 2014;84:208-213.

Appendix 1

Information om forskningsstudien

“Jämförelse av kooperation – om olika påminnelser har betydelse för behandling med avtagbar tandställning - en pilotstudie”

Förfrågan om medverkan

Ditt barn som härmed tillfrågas att delta i studien skall få tandregleringsbehandling vid avdelningen för barn- och ungdomstandvård, Tandvårdshögskolan, Malmö.

Bakgrund och syfte

Ert barn kommer att behandlas med en avtagbar tandställning. För ett lyckat resultat krävs att Ert barn använder sin tandställning enligt givna rekommendationer. För att underlätta användandet av tandställningen vill vi i den här studien prova två olika sätt att påminna Ert barn om att använda tandställningen. Följande påminnelser kommer att utvärderas i studien;

Mobiltelefonens alarmfunktion

Kalender

För att kunna utvärdera vilken metod som är bäst behövs även en kontrollgrupp. Denna grupp får ingen påminnelse, vilket är gängse rutin idag.

Hur går studien till?

Ert barn kommer att slumpvis delas in i en av 3 ovan nämnda grupper:

Påminnelse via telefon.

Via kalender.

Ingen påminnelse alls.

Påminnelsen genom telefon kommer att ställas in av oss som genomför studien i samarbete med dig som förälder. Det kommer att komma ett larm samt en text på telefonen, exempelvis ”Kom ihåg din tandställning !”. Påminnelsen kommer att ske en gång per dag, kvällstid klockan 19.00.

Kalendern kommer att ges ut vid första tillfället och hjälpa Ert barn att bli påmind om att använda sin tandställning. Kalendern fylls i av er och Ert barn när tandställningen används, likt en egen dagbok.

Gruppen utan påminnelse kommer att genomgå behandling som vanligt. Denna grupp kommer att fungera som en kontrollgrupp.

Vi har möjlighet att utvärdera användningstiden av Ert barns tandställning och den här informationen, som kommer samlas in anonymt, ligger till grund för undersökningen.

Besökstiden hos tandläkaren kommer ej att påverkas.

Vilka är riskerna?

Studien innebär ingen risk för behandlingens utfall eller Ert barns hälsa.

Finns det några fördelar?

Studiens syfte är att hjälpa Ert barn att komma ihåg tandställningen och på så sätt minska behandlingstiden.

Hantering av data och sekretess

Uppgifter om behandling och uppföljning journalförs på sedvanligt sätt. De personuppgifter som ingår i studien är avidentifierade. Inga enskilda personer kan spåras. Ansvarig för deltagarens personuppgifter är Malmö högskola. För journaldata och kliniska data gäller personuppgiftslagen (PUL) och insamlad information hanteras enligt gällande sekretessbestämmelser.

Ansvarig är Mikael Ottoson, tel. 040-665 70 57.

Hur får jag information om studiens resultat?

Resultaten kommer att redovisas i en vetenskaplig uppsats. De som deltagit i studien och deras vårdnadshavare är alltid välkomna att ta kontakt med någon av de studieansvariga.

Försäkring och ersättning?

Gängse försäkringar för patienter på tandvårdshögskolan i Malmö gäller.

Det är frivilligt om man vill vara med

Medverkan är helt frivillig. Ert barn kan när som helst hoppa av studien utan att motivera varför och Ert barn kommer inte att kunna identifieras i något register. Ert barn blir kallad till sin tandläkare som vanligt oavsett om Ert barn är med i studien eller inte.

Studieansvariga personer

Övertandläkare, Odont. Dr. Mikael Sonesson

[email protected] Tel: 040-6658447

Tandläkarstudent, Lisa Widegren

[email protected] Tel: 0708468482

Tandläkarstudent, Erik Frilund

[email protected] Tel: 0762898732

Vänliga hälsningar

Mikael Sonesson Lisa Widegren Erik Frilund

Övertandläkare Tandläkarstudent Tandläkarstudent

Appendix 2

Formulär för informerat samtycke Projekt:” Jämförelse av kooperation – om olika påminnelser har betydelse för behandling - en pilotstudie”

Jag har blivit muntligt och skriftligt informerad om mitt barns medverkan i ovanstående projekt och haft möjlighet att ställa kompletterande frågor samt fått dessa frågor besvarade.

Jag är införstådd i att medverkan är frivillig och jag och mitt barn kan avbryta medverkan i studien när vi vill utan att behöva uppge anledning utan att det påverkar min behandling eller framtida omhändertagande.

Deltagarens namn

………………………………………………………………………………………………………………

Underskrift av vårdnadshavare

1………………………………………………………….

2………………………………………………………….

Telefonnummer

……………………………………………………………………………………………………………......

Mailadress

………………………………………………………………………………………………………………

Ort ……………………………………………………… Datum …………......

Underskrift av den som inhämtar samtycke

…………………………………………………………………

PUL-ansvarig: Malmö högskola

Forskningshuvudman: Malmö högskola

Önskar ni mer information angående personuppgiftslagen (PUL), ring kontorstid till Mikael Ottoson 040-665 70 57.

Appendix 3 Sätt gärna upp mig på kylskåpet, eller på badrumsspegeln!

……………….. tandställningsdagbok.

VECKA: ….. VECKA: …..

Dag: MÅNDAG TISDAG ONSDAG TORSDAG FREDAG LÖRDAG SÖNDAG Dag: MÅNDAG TISDAG ONSDAG TORSDAG FREDAG LÖRDAG SÖNDAG Datum: Datum:

08.00 08.00 09.00 09.00 10.00 10.00 11.00 11.00 12.00 12.00 13.00 13.00 14.00 14.00 15.00 15.00 16.00 16.00 17.00 17.00 18.00 18.00 19.00 19.00 20.00 20.00 21.00 21.00

22.00 22.00 23.00 23.00 24.00 24.00 01.00 01.00 02.00 02.00 03.00 03.00 04.00 04.00 05.00 05.00 06.00 06.00 07.00 07.00

Kommentar: Kommentar: