AN ORAL HEALTH WHITE PAPER SERIES | N° 2

INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

This paper reviews the relative efficacy of different methods in preventing and treating and periodontitis based upon the latest evidence from randomized controlled studies, systematic reviews and meta-analyses. AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

TABLE OF CONTENTS

ABSTRACT 2

PLAQUE AND GUM DISEASE 2

GOOD INTERDENTAL CARE IS 3 ESSENTIAL FOR PLAQUE CONTROL

WHICH INTERDENTAL CLEANER 4 IS THE MOST EFFECTIVE? 4 PREVENTION OF 5 TREATMENT OF PERIODONTAL DISEASE

PATIENT PREFERENCE AFFECTS 6 COMPLIANCE WITH TREATMENT

SUMMARY OF KEY RESULTS 7

SUMMARY 8

REFERENCES 9

APPENDIXES 11

© Sunstar Europe Sàrl This white paper was produced by Sunstar Europe in order to summarize the literature on interdental cleaning. AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

ABSTRACT Gingivitis affects up to 90% of the world’ population; periodontitis up to 50% of adults worldwide. Appropriate primary and secondary prevention both depend on daily mechanical plaque removal and are the recommended and most affordable ways to reduce the incidence of these diseases. This review of interdental cleaning approaches is based upon the latest evidence base. The relative efficacy of different interdental cleaning methods is provided in accordance with the latest randomized controlled studies (RCTs), and when available, systematic reviews and meta-analyses. Our review indicates that accumulated data unequivocally demonstrates that interdental cleaning plus is better than tooth brushing alone, for both the prevention and treatment of gum disease. Moreover, Interdental cleaning with brushes and with rubber interdental cleaners is better than interdental cleaning with floss – both in terms of outcomes and patient preference. Compliance with a daily routine at home is one of the greatest issues in dental care. Accordingly, providing patients with care regimens that are easy to use and facilitate compliance are likely to be the most effective and simplest ways to maximize dental hygiene and reduce the incidence of gum disease.

PLAQUE AND GUM become irritated by the harmful bacteria, leading to redness, bleeding on brushing, DISEASE swelling and pain, as well as (Cheung 2010; Pihlstrom 2005). The early and Plaque is a sticky biofilm containing reversible form of gum disease is called bacteria that can accumulate on and gingivitis, which may affect up to 90% between the teeth and below the gumline. of the world’s population (Albandar 2002). With prolonged contact, the If bacteria spreads below the gum line, periodontitis can occur (Pihlstrom 2005) – a severe inflammatory disease where the GUM DISEASE IS VERY COMMON AND CAN ADVERSELY AFFECT inflamed gums pull away from the teeth ORAL HEALTH-RELATED QUALITY OF LIFE AND FUNCTIONING. to form infected pockets, and the body’s immune system is triggered to fight the infection. Over time, the onslaught by ERIODONTITI bacterial toxins and immune factors can is prevalent in up to destroy the integrity of the bones, gums and tissue that support the teeth, leading GUM DISEASE 50% of adults to tooth and bone loss (Pihlstrom 2005). INIVITI worldwide may affect up to Periodontitis is thought to affect around IMPLICATIONS FOR 50% of adults worldwide, and is especially 90% OVERALL HEALTH of the world’s prevalent in older populations (70–90% of population people over the age of 60 years in Europe) (Borgnakke 2013). GUM DISEASE IS ALSO LINKED WITH MANY SYSTEMIC DISEASES Gum disease has a negative impact on a SUCH AS DIABETES AND CARDIOVASCULAR DISEASE. patient’s oral health-related quality of life, especially aspects related to the patient’s

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appearance, and affects their ability to eat • Flossing is commonly recommended, and talk properly if periodontitis results using string floss or floss picks, and can in (Reynolds 2018; Ferreira 2017). be effective at removing interdental Gingivitis has been associated with pain plaque if used properly (Asadoorian 2006). and discomfort, which causes difficulties However, its efficacy is reduced if an when cleaning the teeth (Ferreira 2017). As incorrect technique is used (Drisko 2013; the disease becomes more severe, so does Azcarate-Velázquez 2017). Although the the impact on quality of life (Ferreira 2017). correct technique can be taught, patient Gum disease is also linked with many other compliance with daily flossing is low systemic disorders, including diabetes, because it requires a degree of dexterity cardiovascular disease and pre-term birth and motivation that some patients find (Monsarrat 2016). hard to achieve (Poklepovic 2013). A wide range of low compliance rates, between Gum disease is very common and can 2% and 49%, has been reported for the adversely affect oral health-related quality daily use of floss (Wilder 2016). of life and functioning. Gingivitis may affect up to 90% of the world’ population, while • Interdental brushes (IDBs) with periodontitis is prevalent in up to 50% of cylindrical or conical bristles of varying adults worldwide. sizes can be used to brush between the Gum disease is also linked with many teeth, space permitting (Johnson 2015). systemic diseases such as diabetes and IDBs are thought to be more effective cardiovascular disease. at plaque removal than floss because the bristles are better able to fill the space between the teeth and remove GOOD INTERDENTAL CARE plaque (Johnson 2015). Because IDBs are regarded by patients as being easier IS ESSENTIAL FOR PLAQUE to use than floss, they are much more CONTROL willing to use them (Christou 1998; Imai 2010). However, questions remain regarding their efficacy at reducing gingival Good dental hygiene is important for inflammation and whether they can be gingival health, preventing gum disease and used in orally-healthy people to prevent its associated adverse effects – but relies gum disease (Johnson 2015). on patients effectively cleaning their teeth and gums every day (Jepsen 2017). Manual • Interdental picks are another option disruption of plaque biofilm development used to remove plaque. Newer picks above the gum line remains one of the best have a rubber tip with rubber bristles, forms of treatment (Chandki 2011). designed to stimulate gingival blood There are several options available to flow and remove interdental plaque patients that can be used daily at home (Johnson 2015). These rubber interdental to prevent the build-up of plaque (Johnson picks (RIPs) may be more acceptable 2015). Toothbrushing with a manual or to patients than IDBs because they powered is the most common are easier to use and cause fewer gum method used worldwide (Johnson 2015). abrasions (Hennequin-Hoenderdos 2018). However, although toothbrushing removes biofilm from the buccal, oral, and occlusal • Oral irrigators or air flossers, which surfaces, it does not efficiently into use water or air under pressure, may the interdental areas (Poklepovic 2013; Halappa also remove plaque from teeth and 2015).; moreover, brushing for less than 2 periodontal pockets (Goyal 2012). However, minutes results in removal of only 4% of such devices are generally expensive accumulated plaque (Sheikh-Al-Eslamian 2014). compared to other interdental methods, To help overcome this problem, various and cannot easily be used on the go or interdental cleaning devices have when traveling. been developed and can be used in combination with toothbrushing.

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WHICH INTERDENTAL CLEANER IS THE MOST It is important to note that: EFFECTIVE? • Use of a toothbrush alone or in combination with any interdental product reduces Despite recommendations to use an plaque and inflammation interdental cleaner alongside daily compared with baseline toothbrushing, it has been debated (i.e. before any kind of whether one type of interdental cleaner cleaning takes place) is superior to another (Johnson 2015). Therefore, evidence from randomized controlled trials and from systematic • All interdental devices reviews and meta-analyses was reviewed support the management of for commonly-available interdental gum disease, but to a varying cleaning methods – namely floss, extent (Salzer 2015). interdental brushes (IDBs), and rubber interdental picks (RIPs) (water- and • Some interdental products air-driven options were not considered are more effective than because of their higher cost and more others, and certainly more limited availability). A simple search effective than toothbrushing strategy was devised in PubMed, using alone (Figure 1 and the search term ‘interdental’ and the Appendix). relevant type of trial, in humans. Papers were selected according to whether they compared the efficacy of the techniques PREVENTION OF PERIODONTAL at controlling plaque for prevention of DISEASE gum disease in orally-healthy individuals or treatment of gum disease in patients • Interdental cleaning compared with with gingivitis or periodontitis. toothbrushing alone. In orally-healthy patients, both IDBs and RIPs were more effective than toothbrushing alone, The studies identified included: with significantly greater reductions in interdental plaque with IDBs and • 17 randomized controlled trials: RIPs (Graziani 2018), bleeding from 1 week with IDBs (Bourgeois 2016), and gingival – 3 prevention studies in orally-healthy inflammation with IDBs (Kotsakis 2018). patients (141 (range 39-60) patients, study duration 4 weeks to 3 months) • Interdental brushes compared with floss. IDBs were more effective than – 14 treatment studies in patients floss in orally-healthy patients, resulting with gum disease (1121 (range 9-287) in a significantly greater reduction patients, study duration from a single in interdental plaque from 1 week use to 6 months) (Graziani 2018) and a reduction in gingival inflammation (Kotsakis 2018). • 6 systematic reviews/meta-analyses. • Rubber interdental cleaners compared Details and key results from all studies with floss. New evidence shows that identified are included in the Appendix, RIPs were also more effective than floss including a brief explanation of the trial in orally-healthy patients, leading to designs and efficacy measures that are significantly lower levels ofinterdental used in oral hygiene studies. plaque and inflammation (Graziani 2018).

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• Interdental brushes compared preferable to floss in cleaning interdental with rubber interdental cleaners. areas where the papilla is missing The efficacy of IDBs and RIPs was (Bergenholtz 1984). comparable in orally-healthy patients; both significantly reducedinterdental • Interdental brushes compared with plaque after a single use and bleeding rubber interdental cleaners. The after 4 weeks compared with baseline, efficacy of IDBs and RIPs was initially with no significant differences between comparable when used to treat gum the cleaners (Abouassi 2014). The benefits of disease, but some differences emerged IDBs and RIPs are evident from 1-2 weeks over time. While there was a significant (Graziani 2018; Bourgeois 2016; Abouassi 2014). decrease in interdental plaque and bleeding with both cleaners compared • Gum disease is often seen in older to baseline, there was a significantly people, but prevention is possible in greater decrease in bleeding, gingival younger people; interdental cleaning inflammation and gingival abrasions at significantly reduces plaque and gingival 4 weeks with RIPs compared with IDBs inflammation in orally-healthy subjects (Hennequin-Hoenderdos 2018). The benefits of younger than 30 years of age (Graziani IDBs and RIPs may be more consistent 2018; Bourgeois 2016). after a few weeks (Jared 2005; Hennequin- Hoenderdos 2018).

TREATMENT OF PERIODONTAL • A meta-review of systematic reviews DISEASE indicated that IDBs reduce both plaque and gingivitis and are the most effective • Interdental brushes compared with method for plaque removal (Salzer 2015). toothbrushing alone. IDBs were more However, only weak evidence exists effective than toothbrushing alone that floss and oral irrigators reduce in patients who already had gum gingivitis, with no concomitant evidence disease, resulting in significantly greater for an effect on plaque (Salzer 2015). Most reductions in interdental plaque (Jared studies failed to demonstrate that floss is 2005; Slot 2008), bleeding at 4 weeks (Jared effective in plaque removal for patients 2005), and gingival inflammation (Kotsakis suffering from periodontitis. (Salzer 2015; 2018; Poklepovic 2013). Sambunjak 2011). However, people who brush and floss regularly have less gum • Interdental brushes compared with inflammation and bleeding compared to floss. IDBs were also more effective toothbrushing alone (Sambunjak 2011). than floss in patients with gum disease, leading to a significantly greater • After analysis of the available studies reduction in interdental plaque (Tu 2008; Jackson 2006; Rosing 2006; Jared 2005; and the outcomes assessed within them, Christou 1998; Imai 2012; Slot 2008), gingival IDBs have been ranked the highest at inflammation (Jackson 2006; Jared 2005; being the ‘best’ interdental device for Kotsakis 2018; Poklepovic 2013), pocket depth reducing gum inflammation, while the (Tu 2008; Jackson 2006; Christou 1998; Slot 2008), probability for toothpicks (using hard bleeding (Tu 2008; Noorlin 2007; Jackson materials) and floss being the ‘best’ aids 2006; Jared 2005; Imai 2012; Slot 2008), and was ranked near to zero (Kotsakis 2018). buccal gingivitis (Yost 2006). Whatever their shape, IDBs are more effective • Interdental cleaning, especially with at removing plaque (Rosing 2006) and IDBs, is advantageous in all patient reducing gingivitis (Yost 2006) than floss. populations, including in patients The greater reduction in pocket depth with ; interdental and reported with cleaning can improve clinical periodontal the use of IDBs compared with floss was outcomes and reduce clinical signs of mostly due to the greater efficiency of disease and inflammation over 3 months, interdental brushing in removing dental with minimal professional intervention (Jackson 2006). plaque, rather than compression of interdental papillae (Tu 2008). IDBs are

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PATIENT PREFERENCE an oral hygiene routine, especially when combined with supportive education and AFFECTS COMPLIANCE homecare regimens. WITH TREATMENT To date, several studies have evaluated the patient acceptance of interdental Management of gum disease relies mainly devices. These have shown that patients on a patient’s ability to clean their own prefer IDBs compared with floss, based teeth effectively (Jepsen 2017). Yet patients on the fact they are easier to use and often do not follow recommendations likely to be used more efficiently than floss from healthcare providers (Wilder 2016; (Christou 1998; Noorlin 2007). For example, in a Poklepovic 2013). Toothbrushing alone is usually study of people with intact but bleeding insufficient(Sheikh-Al-Eslamian 2014; van der Weijden interdental gums, 93% of patients ‘agreed’ 2005), and flossing may be ineffective unless or ‘strongly’ agreed to use IDBs daily, the right technique is used (Drisko 2013; Azcarate- compared with 67% of patients for floss Velázquez 2017). However, flossing can be (Imai 2010). In patients with mild-to-moderate difficult to perform correctly (Poklepovic 2013), periodontitis, 90% thought IDBs were leading to reduced motivation in real life ‘easy’ or ‘very easy’ to use compared with (compared with the controlled environment 60% when using floss(Noorlin 2007). Patients of a trial) and a lack of compliance with daily with mild-to-moderate periodontitis also interdental cleaning (Asadoorian 2006). preferred IDBs to floss in another study, rating them as being easier to use (only The prevention and control of gum 12% of patients experienced a problem disease is a lifelong commitment when using the IDB compared with 58% (Jepsen 2017). of patients when using floss) and more Less-demanding methods of interdental effective at cleaning (Christou 1998). cleaning may increase motivation and thus improve patient outcomes Patient compliance with an oral hygiene (Needleman 2005; Wilder 2016). routine may be further improved by using a RIP rather than an IDB. In orally- healthy patients, patient acceptance Thus, less-demanding methods of and willingness to buy the product was interdental cleaning are necessary greater with RIPs than IDBs because they (Asadoorian 2006), which may increase caused less pain during usage and were motivation and change patient behavior significantly more comfortable to use – and thus improve patient outcomes (Abouassi 2014). A recent study in patients (Needleman 2005; Wilder 2016). Utilizing with gum disease has also confirmed the technology and techniques that help to significantly greater patient acceptance improve a patient’s experience should with RIPs compared with IDBs (Figure2) contribute to improving adherence to (Hennequin-Hoenderdos 2018).

I I I T I I I I I I I I I 2

Figure 2. Patient perceptions regarding the use of a rubber interdental cleaner (RIP) compared with an interdental brush: the RIP scored significantly better than IDB for most questions asked (Hennequin-Hoenderdos 2018).

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SUMMARY OF KEY RESULTS

Interdental plaque is significantly reduced with IDBs INTERDENTAL and RIPs, and both are significantly more effective PLAQUE than toothbrushing alone or floss WHEN USED FOR Bleeding of the gums is significantly reduced with PREVENTION BLEEDING IDBs and RIPs, and IDBs are significantly more IN ORALL effective than toothbrushing alone HEALTH SUECTS: GUM Gum inflammation is significantly lower with IDBs INFLAMMATION compared with toothbrushing alone and floss

Interdental plaque is significantly reduced with IDBs INTERDENTAL and RIPs, and IDBs are significantly more effective PLAQUE than toothbrushing alone or floss

Bleeding of the gums is significantly lower with IDBs and RIPs; IDBs are significantly more effective than BLEEDING toothbrushing alone and floss, while RIPs are WHEN significantly more effective than IDBs after a few weeks USED FOR TREATMENT Gum inflammation is significantly lower with IDBs IN PATIENTS compared with toothbrushing alone and floss, and with GUM RIPs compared with IDBs; buccal gingivitis (i.e. where WITH GUM INFLAMMATION DISEASE: the gums touch the inner lining of the cheeks) is also significantly lower with IDBs compared with floss

GINGIVIAL Gingival abrasions are significantly reduced with RIPs ABRASIONS compared with IDBs

POCKET Periodontal pocket depth is significantly reduced with DEPTH IDBs compared with floss

IDBs: interdental brushes RIPs: rubber interdental picks

PATIENT PREFERENCE • Patient acceptance is greater with RIPs than IDBs in prevention studies • Patient acceptance is greater with IDBs than floss, and greater with RIPs than IDBs, in treatment studies

Results clearly demonstrate that It should be noted that newer devices IDBs and RIPs are the most effective such as RIPs were not included in earlier interdental cleaners in the prevention studies. Additional randomized controlled and treatment of gum disease. trials comparing the use of IDBs and RIPs in combination with toothbrushing versus Both are better than toothbrushing alone, toothbrushing alone or in combination with and are more effective than floss at floss would be beneficial to confirm the removing harmful plaque. benefits of each at preventing and treating gum disease. Both IDBs and RIPs are well accepted by patients, with the latest RIP designs associated with greater preference compared with IDBs.

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SUMMARY • Current evidence suggests that patients prefer IDBs to floss. Patients Accumulating data, including also prefer to use RIPs than IDBs for both very recent publications and interdental cleaning because they papers of more than 20 years old, are easier and more comfortable to unequivocally demonstrate that: use and cause less pain. • Interdental cleaning plus • Compliance with a daily oral toothbrushing is better than hygiene routine at home is one of toothbrushing alone for both the the greatest issues in dental care. prevention and treatment of gum Accordingly, providing patients disease. with care regimens that are easy • Interdental cleaning with brushes to use and facilitate compliance and with rubber interdental are likely to be the most effective cleaners is better than interdental and simplest manner to maximize cleaning with floss. dental hygiene.

IDBs AND RIPs ARE THE MOST EFFECTIVE INTERDENTAL CLEANERS IN THE PREVENTION AND TREATMENT OF GUM DISEASE

OTH ARE BETTER THAN TOOTHBRUSHING ALONE AND ARE MORE EFFECTIVE THAN FLOSS AT REMOVING HARMFUL PLAUE

STANDARD IDB RUBBER IDB VS FLOSS

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21 Jepsen S, Blanco J, Buchalla W, Carvalho 30 Reynolds I, Duane B. Periodontal disease JC, Dietrich T, Dorfer C, Eaton KA, Figuero has an impact on patients' quality of E, Frencken JE, Graziani F, Higham life. Evidence Based 2018;19:14-15. SM, Kocher T, Maltz M, Ortiz-Vigon A, 31 Rosing CK, Daudt FA, Festugatto FE, Schmoeckel J, Sculean A, Tenuta LM, Oppermann RV. Efficacy of interdental van der Veen MH, Machiulskiene V. plaque control aids in periodontal Prevention and control of dental caries maintenance patients: A comparative and periodontal diseases at individual study. Oral Health Prev Dent 2006;4:99- and population level: consensus report 103. of group 3 of joint EFP/ORCA workshop on the boundaries between caries and 32 Salzer S, Slot DE, Van der Weijden periodontal diseases. J Clin Periodontol FA, Dorfer CE. Efficacy of inter- 2017;44 Suppl 18:S85-s93. dental mechanical plaque control in managing gingivitis-a meta-review. J Clin 22 Johnson T, Worthington HV, Clarkson JE, Periodontol 2015;42 Suppl 16:S92-105. Poklepovic Pericic T, Sambunjak D, Imai P. Mechanical interdental cleaning for 33 Sambunjak D, Nickerson JW, Poklepovic preventing and controlling periodontal T, Johnson TM, Imai P, Tugwell P, diseases and dental caries (protocol). Worthington HV. Flossing for the Cochrane Database Syst Rev 2015;Issue management of periodontal diseases 12. Art. No.: CD012018. and dental caries in adults. Cochrane Database Syst Rev 2011:Cd008829. 23 Kotsakis GA, Lian Q, Ioannou AL, Michalowicz BS, John MT, Chu H. A 34 Schiffner U, Bahr M, Effenberger S. network meta-analysis of interproximal Plaque and gingivitis in the elderly: a oral hygiene methods in the reduction randomized, single-blind clinical trial on of clinical indices of inflammation. J the outcome of intensified mechanical Periodontol 2018;89:558-570. or antibacterial oral hygiene measures. J Clin Periodontol 2007;34:1068-73. 24 Mandel ID. Why pick on teeth? JADA 1990;121:129-132. 35 Sheikh-Al-Eslamian SM, Youssefi N, Seyed Monir SE, Kadkhodazadeh M. 25 Monsarrat P, Blaizot A, Kemoun P, Ravaud Comparison of Manual and Electric P, Nabet C, Sixou M, Vergnes JN. Clinical Toothbrush in Dental Plaque Removal: research activity in periodontal medicine: A Clinical Trial. Avicenna J Dent Res a systematic mapping of trial registers. J 2014;6:e21046. Clin Periodontol 2016;43:390-400. 36 Slot DE, Dorfer CE, Van der Weijden GA. 26 Needleman I, Suvan J, Moles DR, Pimlott The efficacy of interdental brushes on J. A systematic review of professional plaque and parameters of periodontal mechanical plaque removal for inflammation: a systematic review. Int J prevention of periodontal diseases. J Clin Dent Hyg 2008;6:253-64. Periodontol 2005;32 Suppl 6:229-82. 37 Tu YK, Jackson M, Kellett M, Clerehugh V. 27 Noorlin I, Watts TL. A comparison Direct and indirect effects of interdental of the efficacy and ease of use hygiene in a clinical trial. J Dent Res of dental floss and interproximal 2008;87:1037-42. brushes in a randomised split mouth trial incorporating an assessment of 38 van der Weijden GA, Hioe KP. A subgingival plaque. Oral Health Prev Dent systematic review of the effectiveness 2007;5:13-8. of self-performed mechanical plaque removal in adults with gingivitis using a 28 Pihlstrom B, Michalowicz B, Johnson manual toothbrush. J Clin Periodontol N. Periodontal diseases. Lancet 2005;32 Suppl 6:214-28. 2005;366:1809-1820. 39 Wilder RS, Bray KS. Improving 29 Poklepovic T, Worthington HV, Johnson periodontal outcomes: merging clinical TM, Sambunjak D, Imai P, Clarkson and behavioral science. Periodontol 2000 JE, Tugwell P. Interdental brushing 2016;71:65-81. for the prevention and control of periodontal diseases and dental caries 40 Yost KG, Mallatt ME, Liebman J. in adults. Cochrane Database Syst Rev Interproximal gingivitis and plaque 2013:Cd009857. reduction by four interdental products. J Clin Dent 2006;17:79-83.

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APPENDIX I

A BRIEF GUIDE TO ORAL HYGIENE RANDOMIZED CONTROLLED STUDIES (RCTS)

Oral hygiene RCT studies can be grouped into two types

• Studies of oral hygiene status in relation to dental caries and periodontal disease – usually contain large numbers of patients

• Studies of the effectiveness of the use of various techniques, procedures and devices for cleaning the teeth – usually contain smaller numbers of patients; the key studies in this document fall under this type

Study Design for Oral Hygiene

In oral hygiene studies it is not possible to use the normally-desirable “double-blind” design, as patients clearly know which device they are using. However, a single-blind design is possible, where the examiner is blinded to the treatment used. This is the design used in the best oral hygiene RCTs.

Patients can be randomized into separate treatment groups, including a control group, with the results in one group compared against the other. More frequently, a “half-“ or “split-mouth” design is used, where patients act as their own controls (thereby reducing interindividual variability) and use a different product for each side of the mouth.

Study Design for Prevention Studies

In “prevention” studies in orally-healthy people, “experimental gingivitis” is induced by asking patients to refrain from oral hygiene for a set period of time (from hours to a week or two) before they begin treatment (baseline).

Outcome Measures

In all studies, outcomes are measured at baseline and at the end of the study and compared to see whether there are any significant differences – i.e. whether differences are due to an actual treatment effect rather than to chance. This is represented by the p-value. Usually, if the difference between the treatments results in a p-value of less than 0.05, it is regarded as significant (e.g. p<0.01 is significant, but p=0.06 is not significant).

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APPENDIX II

A BRIEF OVERVIEW OF ORAL HYGIENE OUTCOME MEASURES

Outcome How is it measured? Comments

Plaque Index measures (proportion of tooth surface with plaque) • There are various methods of quantification Interdental plaque • Silness-Löe Index (1964): score 0-3, with 0=no plaque and of dental plaque in the research environment, ranging from simple to very Buildup of plaque 3=abundant plaque; four scores for different areas of the teeth (buccal, lingual, mesial, distal) are averaged complex • Plaque Control Record (1972): a simple method of • Index measures provide composite visual recording plaque in different areas of the teeth (buccal, measurements lingual, mesial, distal), using a solution painted onto the • Image analysis is more “scientifically teeth that stains the plaque rigorous” because images are recorded and • Quigley-Hein Plaque Index: score 0-5, where 0=no plaque can subsequently be validated by another to 5=plaque covering two-thirds or more of the crown of party the tooth • FMPS (Full Mouth Plaque Score): Presence/absence of plaque scores measured dichotomously on six sites per tooth and then calculated as a percentage of the total tooth surface • Interdental full-mouth plaque score (Int. FMPS) NEW Image analysis/planimetric techniques • Quantitative light-fluorescence (QLF) images from buccal surfaces

Bleeding Bleeding on probing (BOP) • BOP is a sign of inflammation Bleeding of the • Bleeding that is induced by gentle manipulation of the gums tissue at the depth of the , or interface FMBS (Full Mouth between the gingiva and a tooth Bleeding score) Bleeding on marginal probing (BOMP) index • The is probed at an angle and the absence or presence of bleeding is scored within 30 seconds of probing on a scale 0-2, where 0=no bleeding to 2=excessive bleeding FMBS (Full Mouth Bleeding score)

Gingival Index measures • Index measures provide composite visual inflammation • Gingival Index: each tooth is divided into four gingival monuments Gum inflammation units (mesial, distal, buccal, and lingual) and given a • Digital image analysis is more precise but Gingivitis score from 0-3, where 0=normal gingiva to 3=severe more cumbersome and newer inflammation. The four scores are then averaged to give Buccal gingivitis • “” is another measure in each tooth a single score this category. NEW Digital image analysis: • Provides good reliability for both intra- and inter-examiner measurements (Smith 2008) • Measured in millimeters using a ; combined with radiographic images

Pocket depth NEW Optical coherence tomography (OCT) • Pocket depth is a common means of Periodontal pocket • OCT images of periodontal pockets is a new method in measuring periodontal inflammation depth development • Periodontal probing is frequently Maximal pocket used but reliability and reproducibility depth are inconsistent; X ray imaging may underestimate bone loss, which can Probing Pocket make early detection difficult – hence the depth development of new measures such as OCT

Gingival abrasion Gingival abrasion (GA) scores • Gingival abrasion can be caused by • Scored by size with probe: abrasions are stained (e.g. blue) toothbrushing and measured using a periodontal probe. They are then scored and small, medium and large in millimeters • Scored by size with photographs, using a predefined method

Patient acceptance Typically measured using patient surveys

13 AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

APPENDIX III

KEY RESULTS FROM RCTS COMPARING MANUAL INTERDENTAL PLAQUE CONTROL TO PREVENT AND TREAT GUM DISEASE

RANDOMIZED CONTROLLED TRIALS – Orally-healthy individuals (prevention)

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Graziani Periodontally- 4 wks MTB alone FMPS • Wk 1: significant decrease in • In periodontally- 2018 healthy young MTB + floss (plaque) plaque in all groups except floss healthy young adults (60) subjects, interdental MTB + IDB FMBS (in- • Wk 4: significant decrease in flammation) plaque and inflammation in all cleaning devices can MTB + RIC groups significantly reduce AngBI plaque and gingival (indicator of • Significantly lower interdental inflammation gingivitis) plaque with MTB + IDB or RIC vs. MTB alone • MTB + IDB or RIC reduced interdental • Significantly less interdental plaque more than MTB inflammation with RIC vs. floss alone

Bourgeois Periodontally- 3 mo MTB + IDB BOIB (in- • Significant decrease in bleeding • Daily use of calibrated 2016 healthy young MTB alone dicator of with MTB + IDB at 1 wk through IDBs has a positive adults (42) gingivitis) to 3 mo compared with baseline impact in reducing Bleeding (no significant difference with interproximal bleeding response to MTB alone) of periodontally healthy pressure in • Preventive fraction for bleeding young participants interdental frequency with MTB + IDB 46% from 1 wk area at 1 wk, 72% at 3 mo • Greater bleeding reduction in anterior (80%) vs. posterior sites (69%) • Presence of bleeding with MTB alone, OR 4.3 • Poorer results with IDB with high baseline bleeding vs. low baseline bleeding (OR 2.3) • Higher odds of bleeding with IDB in posterior vs. anterior sites (OR 2.2) • Larger diameter IDB associated with smaller amount of bleeding

Abouassi Adults (39) 4 wks RIC Gingival • Significant decrease in plaque • RIC similarly effective 2014 IDB bleeding after a single usage of RIC and to IDB Plaque IDB • RIC significantly more removal • Significant reduction in bleeding comfortable than Patient after 4 wks, with no significant metal-core IDB experience differences between groups • RIC can be used as • Significantly greater patient alternative interdental acceptance with RIC in overall cleaning product, may assessment and subitems for be more accepted by less pain during usage, comfort patients of brushing, willingness to buy product

14 AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

APPENDIX III

KEY RESULTS FROM RCTS COMPARING MANUAL INTERDENTAL PLAQUE CONTROL TO PREVENT AND TREAT GUM DISEASE

RANDOMIZED CONTROLLED TRIALS – Patients with gingivitis or periodontitis

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Hennequin- Systemically- 4 wks MTB + RIC BOMP • Significant reduction in bleeding • MTB + RIC more Hoenderdos healthy MTB + IDB (indicator of and plaque with RIC and IDB effective than MTB + 2018 young gingivitis) vs. baseline – but no significant IDB in reducing gingival adults with PI (plaque) differences between groups, inflammation after 4 experimental apart from significantly less wks gingivitis (42) GAs (gingival bleeding with RIC vs. IDB at 4 abrasions) • RIC caused less wks gingival abrasion and • Significantly fewer gingival was appreciated more abrasions with RIC by participants than • RIC considered significantly IDB more pleasurable to use

Larsen 2017 Periodontal 3 mo Conical IDB Plaque scores • Overall, no difference between • Conical IDBs less maintenance Cylindrical Bleeding conical and cylindrical IDBs effective than patients (51) IDB upon pocket • Significantly higher plaque cylindrical IDBs probing and bleeding scores at lingual regarding lingual scores approximal sites with conical approximal plaque removal Probing IDB (increase in plaque and pocket depth bleeding scores compared with • In patients receiving baseline) supportive periodontal • No difference in probing pocket therapy, cylindrical IDB depth between IDBs should be first choice to obtain and maintain gingival

Mwatha Young and 4 wks MTB alone MGI • Significantly larger reductions • Addition of 2017 old adults MTB + string (gingivitis) in MGI in all three floss groups interproximal cleaning with mild to floss RMNPI compared to MTB alone at day to MTB significantly moderate 14 (primary endpoint) reduced gingivitis and MTB + two (plaque) gingivitis • Benefits persisted for up to 4 plaque vs. MTB alone (287) different GBI types air floss (bleeding) wks • String and air floss provided a similar (4 groups) reduction in gingivitis and plaque

Stone 2015 Adults with 20 wks Sonic TB + OHIP (impact With Sonic TB + IDB vs. MTB • A structured plaque gingival IDB on life) alone: control intervention manifesta- MTB alone Pain • Significant improvements in effective in improving tions (79) OHIP oral health-related PI (plaque) quality of life and Mucosal • Improvements in functional clinically observed disease score limitation, psychological gingival lesions discomfort and physical Cost- disability at 4 and 20 wks, and effectiveness psychological disability at 20 wks • Reduction in plaque • Improvements in mucosal disease indices at 4 and 20 wks

15 AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

APPENDIX III

KEY RESULTS FROM RCTS COMPARING MANUAL INTERDENTAL PLAQUE CONTROL TO PREVENT AND TREAT GUM DISEASE

RANDOMIZED CONTROLLED TRIALS – Patients with gingivitis or periodontitis

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Tu 2008 Young and 12 wks MTB + floss PPD (pocket • Significantly greater reduction in • Greater reduction in (re-analysis old adults MTB + IDB depth) PPD and percentage sites with pocket depth and of Jackson with chronic PI (plaque) bleeding on probing with MTB + bleeding on probing 2006) periodontitis IDB vs. MTB + floss with MTB + IDB vs. (77) BOP MTB + floss mostly due (bleeding) • Most changes occurred during first 6 wks to greater efficiency of interdental brushing • Greater reduction in PI with MTB in removing dental + IDB vs. MTB + floss, leading to plaque (rather than greater pocket depth reduction compression of and greater improvement in interdental papillae) bleeding on probing • Improved oral hygiene performance can reduce gingival inflammation and yield greater pocket reduction and less bleeding on probing

Noorlin Untreated 1 mo MTB + IDB Probing • Significant differences in • Use of MTB + IDB or 2007 adults MTB + floss depth supragingival and subgingival floss resulted in similar with mild- BOP plaque scores with MTB + IDB beneficial effects on moderate (bleeding) an MTB + floss over time, but no subgingival plaque and periodontitis significant differences between proximal gingival health (prior to de- Recession groups (gum) • IDB is more likely to be bridement) • Significant reduction in BOP, used efficiently than (10) probing depth and recession floss over time for IDB sites, but not floss sites • Patients preferred IDB because of its simpler method of use

Schiffner Older 6 mo MTB + Gingivitis • Significantly lower plaque and • Greater plaque 2007 patients interdental Plaque gingivitis scores at 6 mo vs. reduction with intensive (106) treatment baseline in all groups manual oral hygiene Oral • Significant reductions in than combination of antibacterial gingivitis between control group antibacterial rinse and mouth rinse and all other groups, but not usual oral hygiene procedures Manual + between intervention groups antibacterial • Only groups with improved • Gingivitis reduced by combination manual oral hygiene showed both intensive manual significant improvements in oral hygiene and No specific antibacterial rinse regimen plaque scores vs. control • Combining intensive (4 groups) manual oral hygiene with antibacterial rinse did not result in further gingivitis reduction

16 AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

APPENDIX III

KEY RESULTS FROM RCTS COMPARING MANUAL INTERDENTAL PLAQUE CONTROL TO PREVENT AND TREAT GUM DISEASE

RANDOMIZED CONTROLLED TRIALS – Patients with gingivitis or periodontitis

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Jackson Young and 12 wks MTB + floss PI (plaque) • Significant reductions from • Interdental cleaning, 2006 old adults MTB + IDB RICL baseline for all indices in both especially with IDB, with chronic (papillae groups enabled patients with periodontitis level) • At 6 wks, IDB group improved chronic periodontitis (prior to de- to improve clinical EIBI (gingival significantly more than floss bridement) group in every parameter periodontal outcomes (77) inflammation) and reduce clinical Probing • By 12 wks, changes in plaque, signs of disease and depths papillae level, and probing inflammation over 12 depths significantly greater in wks BOP IDB vs. floss group • Significant improvements achieved with minimal professional intervention before thorough root surface • IDB significantly outperformed floss at 6 wks (all indices) and 12 wks (interdental plaque, papillae height, probing depth)

Rosing Adults with Single Floss PI (plaque) • Significant decrease in plaque • In individuals 2006 periodontitis use Cylindrical with all three instruments vs. in periodontal (50) IDB baseline maintenance care, IDB – regardless of Conical IDB • Significantly greater decrease with both IDB vs. floss their shape (conical, cylindrical) – are more efficacious in interdental supragingival plaque removal than floss

Yost 2006 Adults with 6 wks String floss EIBI • With all four products, • Dental floss, the gingivitis Flossers (bleeding) significant reduction in recognized “gold (120) Plaque interdental plaque and standard” for IDB reduction in interdental gingivitis reduction, RIC Gingivitis gingivitis scores both lingually was matched in and buccally at 6 wks vs. performance by baseline flossers and RIC, but • No statistical differences surpassed by the IDB between products on lingual • All products performed interdental sites comparably for plaque • Significantly greater reduction reduction and removal, in gingival index score buccally and for reduction in with IDB vs. other three inflammation products • On the buccal surfaces, • No differences among products the greatest reduction regarding bleeding in gingivitis was achieved with the IDB

17 AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

APPENDIX III

KEY RESULTS FROM RCTS COMPARING MANUAL INTERDENTAL PLAQUE CONTROL TO PREVENT AND TREAT GUM DISEASE

RANDOMIZED CONTROLLED TRIALS – Patients with gingivitis or periodontitis

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Jared 2005 Adults with 4 wks Antiseptic-re- Plaque • Significantly lower plaque levels • Compared to MTB gingivitis leasing IDB Gingivitis with all three IDB vs. MTB alone alone and floss, daily (152) at 2 and 4 wks use of IDBs was Two other Interproximal IDB products • Significant improvement in effective in reducing gingival interproximal plaque, Floss bleeding interproximal gingival bleeding with antiseptic-releasing IDB gingivitis scores, and MTB alone at 2 wks; significantly better interproximal bleeding on probing (5 groups) outcomes with all three IDB at 4 wks vs. MTB alone • Benefits evident • Significantly greater reduction at 2 wks, but more in interproximal bleeding upon consistent at 4 wks probing with all three IDB vs. • The antiseptic-releasing floss and MTB alone at 2 and 4 IDB did not appear to wks confer a consistently • No clinically superior results independent with antiseptic-releasing IDB vs. incremental benefit other two IDB

Schmage Adults with 1 wk MTB + IDB Proximal • Overall reduction in average PBI • Manual interproximal 1999 gingivitis MTB + floss plaque • Substantially less interproximal cleaning was more (35) PBI plaque remained after manual effective than MTB + mechanical cleaning mechanical (bleeding) interdental cleaning (5%) interdental Interdental compared with mechanical cleaner bleeding cleaning (40%) tendency on • Cleaning efficiency of manual stimulation and mechanical methods was comparable in only one interproximal space size • Interdental bleeding on stimulation significantly higher with mechanical manual cleaning at the end of the study

Christou Adults with 6 wks MTB + floss Plaque At 6 wks vs. baseline with MTB + • MTB + IDB more 1998 moderate MTB + IDB Gingival IDB vs. MTB + floss: effective in plaque to severe inflammation • Significantly greater reduction removal and results periodontitis in plaque in larger reduction of (prior to de- Probing probing depth than bridement) depth • Significantly greater reduction MTB + floss in probing depth/pocket (26) • Differences were • Reduced bleeding with both small, but indicate that interdental devices, with no in combination with significant differences patient preferences, • Significantly greater patient IDB preferable to floss acceptance with IDB: more for interdental plaque problems experienced with removal in patients with floss, IDB felt to be more moderate to severe efficacious periodontitis

Bergen- Adults with 8 wks Floss Plaque • No difference in achieved • IDB preferable to floss holtz 1984 periodontal IDB x 3 cleanliness after use of different in cleaning interdental disease (9) IDB areas where the papilla (crossover is missing study) • No gingival damage or damage to hard tissue of teeth observed with IDB or floss

18 AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

APPENDIX III

KEY RESULTS FROM RCTS COMPARING MANUAL INTERDENTAL PLAQUE CONTROL TO PREVENT AND TREAT GUM DISEASE

SYSTEMATIC REVIEWS / META-ANALYSIS – Varied subjects

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Kotsakis 22 trials: 4-24 Floss GI (gingival • IDB yielded largest reduction • IDB and water jets 2018 Healthy wks Powered inflammation) in gingival inflammation as ranked high for (438) flossing BOP toothbrushing adjuncts, reducing gingival Gingivitis (bleeding) followed by water jet bleeding, whereas Toothpicks toothpicks and floss (1365) Toothpicks + Plaque • Rankings based on posterior probabilities revealed that ranked last Periodontitis intensive oral Probing (74) hygiene IDB and water jet had highest • Patient-perceived depth probability of being “best” benefit of aids is not Water jet for reduction of gingival clear because gingival irrigation inflammation inflammation measures IDB • Probability for toothpick and are physical indicators of periodontal health Gum mas- floss being the “best” aids was sagers near zero MTB alone • Except for toothpicks, all aids were better at reducing GI vs. Powered TB MTB alone alone Powered TB + water jet (10 total)

Salzer 2015 6 systematic – Floss (n=2 Plaque • Moderate evidence that MTB • IDBs most effective reviews reviews) Gingivitis + IDB reduces plaque and method for interdental IDB (n=2) gingivitis plaque removal Woodsticks • Weak evidence of unclear or • Majority of available (n=1) small magnitude that MTB + studies fail to dental floss, woodsticks or oral demonstrate that floss irrigator reduces gingivitis, and is effective in plaque (n=1) no concomitant evidence for removal effect on plaque • However, all interdental devices support management of gingivitis to a varying extent

SYSTEMATIC REVIEWS / META-ANALYSIS – Orally-healthy individuals

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Sambunjak Healthy 6 mo MTB + floss Plaque • Significantly greater reduction • Some evidence that 2011 adults, MTB alone Gingivitis in gingivitis with MTB + floss vs. MTB + floss reduces prevention MTB alone at 1, 3 and 6 mo gingivitis compared to of gingivitis • Small reduction in plaque at 1 MTB alone and dental or 3 mo with MTB + floss, but • People who brush and caries evidence is weak and very floss regularly have (1083, 12 unreliable less gum bleeding trials) compared to MTB alone • Weak and very unreliable evidence of a small reduction in plaque with MTB + floss

19 AN ORAL HEALTH WHITE PAPER SERIES | N° 2 INTERDENTAL CLEANING TO PREVENT AND TREAT GUM DISEASE: STATE OF THE EVIDENCE

APPENDIX III

KEY RESULTS FROM RCTS COMPARING MANUAL INTERDENTAL PLAQUE CONTROL TO PREVENT AND TREAT GUM DISEASE

SYSTEMATIC REVIEWS / META-ANALYSIS – Patients with gingivitis or periodontitis

Study characteristics Study Follow- Key Key results Author conclusions Patients (N) up Interventions outcomes Poklepovic Adults 4-24 MTB + IDB Prevention of MTB + IDB vs. MTB alone: • Only one study 2013 (354, 7 trials) wks MTB + floss periodontal • Very low-quality evidence from looked at whether disease, MTB + IDB was better MTB alone one study for a reduction in plaque, gingivitis at 1 mo, favoring of use than MTB alone, and dental caries of IDB there was very low- quality evidence for a MTB + IDB vs. MTB + floss: reduction in gingivitis • Reduction in gingivitis in favor and plaque at 1 mo of IDB vs. floss at 1 mo in seven • Also low-quality studies (low-quality evidence) evidence from seven (translates to 52% reduction in studies that IDB gingivitis) reduces gingivitis vs. • Insufficient evidence to claim floss at 1 mo benefit for either IDB or floss for • Insufficient evidence to reducing plaque at 1 and 3 mo determine whether IDB reduced or increased plaque levels compared to floss

Imai 2012 Adults with 4-12 MTB + IDB Bleeding • Reduction of bleeding greater • MTB + IDB effective periodontitis, wks MTB + floss Plaque with MTB + IDB than MTB + alternative to MTB gingivitis, or floss (four studies) + floss for reducing both (446 (after de- bleeding and plaque bridement) • Significant reduction in plaque patients, 7 with MTB + IDB vs. MTB + floss between four and 12 trials) (seven studies) wks

Slot 2008 Adults with Up to MTB + IDB Markers of • MTB + IDB removes more dental • More dental plaque periodontitis 12 wks MTB alone periodontal plaque than MTB alone, and is removed with MTB + (9 trials) or other inflamma- even more effective than dental IDB than MTB alone, interdental tion (plaque, floss or woodsticks floss or woodsticks devices gingivitis, • Positive significant difference • Inconclusive evidence bleeding, using IDB with respect to for effect on gingival pockets) plaque scores, bleeding scores inflammation; no and probing pocket depth; difference in effect of reduction of pocket depth more IDB on parameters of pronounced with IDB than floss gingival inflammation • Positive significant difference compared to floss in plaque index with IDB • Reduction of pocket compared with floss depth with IDB more • Evidence for effect on gingival pronounced than with inflammation less conclusive floss

AngBI, angulated bleeding index; BOIP, bleeding on interdental brushing index; BOMP, bleeding on marginal probing; BOP, bleeding on probing (interdental sites); EIBI, Eastman interdental bleeding index; FMBS, full-mouth bleeding score; FMPS, full-mouth plaque score; GA, gingival abrasion score; GI, gingival index; GBI, gingival bleeding index; ICU, intensive care unit; IDB, interdental brush; MGI, modified gingival index; mo, months; MTB, manual toothbrush; OHIP, oral health impact profile; OR, odds ratio; PBI, papillary bleeding index; PI, plaque index; PPD, probing pocket depth; RIC, rubber interdental cleaners; RICL, relative interdental papillae level; RMNPI, Rustogi Modified Navy Plaque Index; TB, toothbrush; wk(s), week(s).

20 ADVERTORIAL

WHY IS ORAL HEALTH still such a big challenge?

BECAUSE... IN THEORY IN PRACTICE

+

Clinical trials have clearly shown Ineffective cleaning is common3 IT RELIES ON PATIENTS1 and when it that an interdental cleaning strategy as patients often do not follow comes to interdental care, patient guided by patients’ interdental spaces recommendations from healthcare compliance is low.2 provides excellent results and helps providers4 and the prevalence of prevent gum disease3. gum disease remains high.

WHAT CAN WE DO?

MAKE IT EASY FOR PATIENTS! AND OPEN THE DOOR TO EFFECTIVE INTERDENTAL CLEANING

Less demanding methods of Patients prefer soft rubber picks Soft rubber picks massage gums interdental cleaning increase because they are easier and more and clean between teethNEW motivation and patient outcomes5 comfortable to use, and cause less pain6 without abrasion

HELP YOUR PATIENTS MOVE UP THE ORAL CARE LADDER!

GUM® SOFT-PICKS® GUM® SOFT-PICKS® GUM® SOFT-PICKS® ORIGINAL COMFORT FLEX ADVANCED

1. JEPSEN, 2017 2. POKLEPOVIC, 2013 3. SALZER, 2015; POKLEPOVIC T 2013; SAMBUNJAK D 2011 4. SHEIKH-AL-ESLAMIAN, 2014 4. WILDER, 2016 5. NEEDLEMAN, 2005; WILDER, 2016 6. HENNEQUIN, 2018