Rajiv Gandhi University of Health Sciences s185

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA ANNEXURE - II 2013

PROFORMA FOR THE REGISTRATION OF SUBJECT FOR DISSERTATION BY: Dr. Punith Shetty Postgraduate Student

DEPARTMENT OF PUBLIC HEALTH DENTISTRY

Krishnadevaraya College of Dental Sciences and Hospital, Bangalore – 562 157 RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE CANDIDATE DR.PUNITH SHETTY AND ADDRESS POST GRADUATE STUDENT (IN BLOCK LETTERS) DEPARTMENT OF PUBLIC HEALTH DENTISTRY, KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES, KRISHNADEVARAYA NAGAR HUNASAMARANHALLI, BANGALORE INTERNATIONAL AIRPORT ROAD, BAGALORE -562157.

KRISHNADEVARAYA COLLEGE OF DENTAL 2. NAME OF THE INSTITUTION SCIENCES, BANGALORE

3. COURSE OF THE STUDY MASTER OF DENTAL SURGERY IN PUBLIC AND SUBJECT HEALTH DENTISTRY

4. DATE OF ADMISSION TO 30th MAY 2013 COURSE

5. TITLE OF THE TOPIC ORAL HEALTH STATUS OF 13-15 YEAR OLD SCHOOL GOING CHILDREN AND ESTIMATION OF FLUORIDE CONTENT IN DRINKING WATER OF CHIKKABALAPUR DISTRICT. . 6.

BRIEF RESUME OF INTENDED WORK:

6.1 NEED FOR STUDY

Oral health is a very important component of the general health of the people. The high prevalence and severity of oral diseases such as dental caries, periodontal disease, oral cancer and various stages of malocclusion and the crippling nature of these diseases lead to significant absenteeism in schools and economic loss in the working population. Dental illness thus contributes to considerable reduction in national production and overall national development. Dental fluorosis is an endemic oral disease in Chikkaballapur district. The source of drinking water in Chikkaballapur district is mainly from ground water.The groundwater dependence of agrarian states like Karnataka is high.1The fluoride content in the district of Chikkaballpur is high, with levels of fluoride as high as 2.01mg/l,2 with Bagepalli having the highest fluoride content in the drinking water. However, further detailed information on the amount of Fluoride in drinking water in Chikkaballapur district is scant in the literature. The present study is planned to find out the oral health status of 13-15 year school going children and also to estimate the amount of fluoride in drinking water of all Chikkaballapur district.

6.2REVIEW OF LITERATURE

E.S.Akapata et al (1997) conducted a study between fluoride levels in well drinking water, severity of dental fluorosis and dental caries in the Hail region of Saudi Arabia, 2355 rural children aged 12-15 years were examined. Over 90% of the children had fluorosed teeth and chi-square tests showed a strong association between fluoride level in well drinking water and severity of dental fluorosis. The children examined in this study were selected by a two-stage stratified cluster sampling technique. Hail villages together with their populations of 12-15year-olds were stratified according to the fluoride concentrations of the wells used. After informed consent had been obtained from the community heads and school authorities, the subjects, were examined for dental caries, following the WHO criteria. Their teeth were dried with gauze, illuminated with a pocket torch, and the facial tooth surfaces examined for dental fluorosis. The teeth were classified using the modified Thylstrup -Fejerskov Index. Since fluoride in well water had little influence on caries experience and is causing dental fluorosis, it should be removed by defluoridation or the rural population should be provided with an alternative source of drinking water with lower fluoride concentration.3

Jagan KumarBaskardoss et al (2008) conducted a study to assess the prevalence of dental fluorosis and selected risk factors a study was conducted on 1800 children from all the Kanyakumari district ,studying in classes 6th to 10th were examined .The survey was performed during a span of eight months, to encompass all the objectives of the study two questionnaires were used, one was the WHO assessment and the other was an individual questionnaire specifically designed for the study .The fluoride content in water was obtained from the Tamilnadu water and drainage department of Kanyakumari district, which had conducted a fluoride mapping in the year 2000. The index used to assess the dental fluorosis was Dean fluorosis index. The result was that there was a significant difference in the level of fluoride between rural and urban area and the prevalence of dental fluoride was higher in children who consumed pipe water as compared to ground water.4

GopalanViswanathan et al (2008) conducted a study in Dindigul district of Tamilnadu to estimate the fluoride exposure through drinking water from people of different age groups and to elucidate the fluoride endemic areas through mapping and assessment of fluoride exposure was achieved by estimating fluoride levels in drinking water using fluoride ion selective electrode method, Google earth and isopleth mapping of fluoride was done for the mapping of fluoride endemic areas. From the study it was estimated that Nilakottai block of Dindigul district in Tamilnadu is highly endemic to fluoride. Exposure of fluoride among different age groups was calculated in this block, which comprises of 32 villages. From the results the people of Nilakottai block are advised to consume drinking water with fluoride level less. It was also recommended to the government authorities to take serious steps for providing water less of fluoride.5

E.S.Akpata et al (2009) conducted a study to know the knowledge of fluoride levels in drinking water , a fluoride mapping was done in Nigeria. The fluoride levels in drinking water sources from 109 were randomly selected from local government areas in the 6 Nigerian geopolitical zones were determined. From the results, maps showing local government areas with fluoride concentration exceeding 0.3 ppm were drawn .ANOVA and t-test were used to determine the significance of the differences between the fluoride levels in the drinking water sources. The collection of drinking water was done with polythene bottles from all drinking water sources, at the headquarters of the each selected local government areas, as well as from a locality randomly selected from the local government areas. The fluoride concentration in each water sample was determined, in quadruplicates by combined ion chromatographic, conductmetric and spectrophotometric techniques. The fluoride concentration in water from boreholes tended to be higher than that from other sources of drinking water in some of the geopolitical zones and the t-test showed this difference to be statistically significant.6

Ayat Rahmani et al (2010) conducted a study to determine whether a relationship exists between the groundwater fluoride concentration and dental caries in children living in the Noorabademamasani area of Fars Province in Iran. The residents all have essentially the same socio-economic living standards and nutritional conditions. All3349 children in the four age groups of 6,9,10 and 12 years were surveyed in seven village districts of the area. Making a total of 3349 children including 1659 boys and 1690 girls. For the determination of dental caries, decayed permanent and deciduous teeth, but not filled or missing teeth, were recorded for each child in the above age groups in each village district according to the 1997 WHO criteria. Fluoride levels in the drinking water was measured by the SPADNS method. The linear regression analysis shows little significance between fluoride and dental caries.7

6.3 OBJECTIVES OF THE STUDY 1. To assess the oral health status of 13-15 year old School going children of Chikkaballapur District by using the WHO oral assessment form (1997).8 2. To assess Dental fluorosis using Thylstrup and Fejerskov index(1978).9 3. To estimate the fluoride content of drinking water of the study population by SPADNS method(sodium 2parasulfophenylazo-1,8dihydroxy-3,6-naphthalene disulfonate).10 4. To correlate dental caries and dental fluorosis with the fluoride level in drinking water among the study population.

7 MATERIALS AND METHODS

7.1 SOURCE OF DATA

This is an in vivo cross sectional analytical study. The study sample comprises of 13-15 year old school going children of the various villages of the Chikkaballapur district.

7.2 METHODS OF COLLECTION OF DATA

SAMPLING TECHNIQUE

Multistage sampling will be used to derive the sample. The school going children of 13-15 years old would be selected, from the six taluks of Chikkaballapur district, which has 198 villages. The schools in these villages would be randomly selected and care would be taken to proportionately distribute the sample according to the age and sex groups.

SAMPLE SIZE DETERMINATION The estimated sample size will be obtained from the following formula

Where, N = sample size Z = 1.96 when is assumed to be 0.05. ε = 0.02, variance estimated to be 2%. p = 80%, prevalence of dental caries.11

N= 1.96*1.96(1-0.05/2)(1-0.80) 0.02*0.02*0.80

N(SAMPLE SIZE) =2340~2400

2400 school going children in the age group of 13-15 year old from Chikkaballapur district will be included in the study.

SAMPLE SELECTION

INCLUSION CRITERIA

1. The study subject must be a native of that area since birth. 2. The school going children must be present on the day of examination.

EXCLUSION CRITERIA

1. Study subjects who are not a native of that area since birth.

METHOD

This study includes 2400 subjects of the age group 13-15 year school going children of Chikkaballapur district. The required permission to conduct the study will be taken from the concerned authorities(ANNEXURE II-A). Oral health status will be assessed by using the WHO Oral Health Assessment form 1997 (ANNEXURE II-B).8 The fluoride estimation of all the sources of drinking water of Chikkabalapur district will be done. The water sample would be collected in a clean and sterilized plastic bottle.11The bottle will be cleansed in the same water before collecting the sample.500ml of the water sample will be collected and the sample will be coded accordingly .The fluoride content of the drinking water will then be assessed by SPADNS method.(sodium 2parasulfophenylazo- 1,8dihydroxy-3,6-naphthalene disulfonate).10 Dental Fluorosis of the study population will be estimated by using the Thylstrup and Fejerskov index - 1978(ANNEXURE II-C).9 And the correlation of dental caries and dental fluorosis with the fluoride level of drinking water in the study population will be assessed. After oral examination an audio visual presentation on correct oral hygiene practices will be presented to all the children of the schools.

MATERIALS

1. Artificial/Natural light. 2. Mouth Mirror. 3. CPI probe. 4. Tweezers. 5. Gauze (2x2 inches). 6. Mouth mask. 7. Head cap. 8. Gloves. 9. Disinfectant solution. 10. WHO oral health assessment form (1997). 11. Thysltrup and Fejerskov index form. 12. Sterilized plastic bottles.

STASTICAL ANALYSIS

Data collected will be compiled using Microsoft excel sheet ®. Appropriate statistical tests will be conducted to analyze the collected data.

7.3 Does the study require any investigation or interventions to be conducted on patients or both humans or animals? If so, please describe briefly.

Yes, demographic data will be collected and oral health status will be assessed.

7.4Has ethical clearance been obtained from your institute in case of 7.3 Yes. 8. REFERENCES 1. Ground water information booklet Chikkballapur district Karnataka. Ministry of water resources central ground water government of India. [internet]; updated on2012.[28.10.13];http:/www.cgwb..gov.in./chikballapur_dist_brochure 2012. 2. Integrated management information system. Ministry of drinking water and sanitation [internet] ;updated on 2011.[26.10.13];http:/www.indiawater.gov.in/imis web/reports/rep_ list of quality affected habitation statewise.aspx .integrated management information system, ministry of drinking water and sanitation. 3. Akpata.E.S, Fakiha.Z, Khan.A. Dental fluorosis in 12-15 year old rural children exposed to fluorides from drinking water in the hail region of Saudi Arabia. Community Dent Oral Epidemiology .1997;25(3):24-7. 4. Jagankumarbaskaradoss ,Clement roger B,Aswathnarayanan. Prevalence of dental fluorosis and associated risk factors in 11-15 year old school children of Kanyakumari district ,Tamilnadu district; a cross sectional survey. Indian journal of dentistry and research. 2008; 19(4):297-303. 5. Goplanviswanathan, Jaswanth.A, Gopal Krishna S , Siva ilango S. Mapping of fluoride endemic area and assessment of fluoride exposure. Science of total environment .2009: 1579-1587. 6. Akpata E.S, DanfilloI.S,OtohE.C, MafenJ.O.Geographic mapping of fluoride levels in drinking water sources in Nigeria. African health sciences .2009;9(4):227 -233. 7. Ayatrahmani ,KouroshRahmani ,Amir HosseinMahvi,MasoudUsefie. Drinking water fluoride and child dental caries in Noorabademamasani,Iran.Research report fluoride. 2010; 43(3): 187-193. 8. World health organization.Oral health surveys; India; A.I.T.B.S,4TH edition. 9. Thylstrup, Fejerskov.Health effects of ingested fluoride. National Academy of Sciences .1993:171. 10. Lenore S Clescori,Arnold E Greenberg,Andrew D Eaton. Standard methods for the examination of water and waste water; 20th edition.

11. Dental council of India. National oral health survey fluoride mapping, Karnataka. 2002-2003. 9. SIGNATURE OF CANDIDATE

10. REMARKS OF THE GUIDE

11. NAME AND DESIGNATION OF (IN BLOCK LETTERS) 11.1 GUIDE DR. MADHUSUDAN KRISHNA PROFESSOR

11.2 SIGNATURE

11.3 CO-GUIDE (IF ANY) DR. R.MURALI PROFESSOR AND H.O.D.

11.4 SIGNATURE 11.5 HEAD OF THE DR. R.MURALI DEPARTMENT

11.6 SIGNATURE

12. 12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL

12.2 SIGNATURE

ETHICAL CLEARENCE FOR DISSERTATION STUDY Ethical clearance for dissertation study, ORAL HEALTH STATUS OF 13-15 YEAR OLD SCHOOL GOING CHILDREN AND ESTIMATION OF FLUORIDE CONTENT DRINKING WATER OF CHIKABALLAPUR DISTRICT by Dr PUNITH SHETTY, postgraduate student in the Department of Public Health Dentistry, Krishnadevaraya College of Dental Sciences and Hospital, under Rajiv Gandhi University of Health Sciences, Karnataka. Ethical committee meeting was held on 05/11/2013 at Krishnadevaraya College of Dental Sciences & Hospital. The Members discussed all the ethical issues involved 1. Review of literature and remarks of previous studies. 2. Risks and expected beneficial effects.

3. Cost factor.

4. Supervision by Senior Staff members.

5. ICMR guidelines for Research Studies.

The members were satisfied regarding all the above Ethical issues concerned and ethical clearance was granted for the Dissertation Study. ETHICAL COMMITTEE MEMBERS

Sl.n NAME & DESIGNATION POSITION SIGNATURE 1. Dr. H. Nandakumar, Principal & HOD, Oral Surgery Chairman 2. Dr.S.M.Sharath Chandra, Prof & HOD, Conservative Co-Chairman Dentistry 3. Dr.GundaRao,NGO Social Activist Member 4. Dr.MohumedSadiqh.B.A, Advocate Member 5. Dr.Vijay Mohan Reddy.N.H,Administrative Medical Member Officer,Government General Hospital,Yelahanka 6. Dr. Srinivasa.G.N,Physician,Government General Member Hospital 7. Dr.NikhilanandHegde, HOD, Orthodontics Member 8. Dr.M.L.V.Prabhuji, HOD ,Dept of Periodontics Member 9. Dr.ShivaShankar.M, Prof. & HOD, Prosthodontics Member 10. Dr.M.B.Radhika, Prof.& HOD, Oral Pathology Member 11. Dr.Murali.R, Prof. & HOD, Public Health Dentistry Member 12. Dr.DeepakVishwanath, Prof &HOD,Pedodontics Member 13. Dr.VijeevVasudevan,Professor&HOD,Oral Medicine Member 14. Dr.N.Srinath,Professor,Oral Surgery Member 15. Dr.Prabhakar,Anesthetist Member

ANNEXURE II-A

Consent form DEPARTMENT OF PUBLIC HEALTH DENTISTRY KRISHNADEVARAYA COLLEGE OF DENTAL SCIENCES DENTAL AND HOSPITAL,

I, ______have been informed about involvement of my child ______, aged ______in the study in the language that I can understand.  I agree to give my child's personal details like name, age, sex, address, previous dental history and the details required for the study to the best of my knowledge.  I will co-operate with the dentist for my child's intra oral examination  I will follow the instructions given by the doctor during the study.  I permit the operator to utilize the information given by me and the results obtained from this study for presentation and publication.  My child is participating with my own will and wish.  If for any reason my child is unable to participate in the study, for reasons unknown, I can withdraw from the study.  I have read, gone through and understood the above information given by the doctor about the study.  I have entered and signed this application.

 Dentist name : Parent Signature  Address :  Phone no. : Principal Signature  Dentist signature :  Date :  Place

ANNEXURE-II-B - WHO Oral Health Assessment Form

ANNEXURE II-C

The Thylstrup-Fejerskov (TF) Index(1978).

Score Criteria

0 Normal translucency of enamel remains after prolonged air-drying.

1 Narrow white lines corresponding to the perikymata. [Dean = Questionable/Very Mild]

2 Smooth surfaces: More pronounced lines of opacity that follow the perikymata. Occasionally confluence of adjacent lines.Occlusal surfaces: Scattered areas of opacity <2 mm in diameter and pronounced opacity of cuspal ridges. [Dean = Questionable/Very Mild]

3 Smooth surfaces: Merging and irregular cloudy areas of opacity. Accentuated drawing of perikymata often visible between opacities.Occlusal surfaces: Confluent areas of marked opacity. Worn areas appear almost normal but usually circumscribed by a rim of opaque enamel. [Dean = Very Mild/Mild]

4 Smooth surfaces: The entire surface exhibits marked opacity or appears chalky white. Parts of surface exposed to attrition appear less affected.Occlusal surfaces: Entire surface exhibits marked opacity. Attrition is often pronounced shortly after eruption. [Dean = Mild/Moderate]

5 Smooth surfaces and occlusal surfaces: Entire surface displays marked opacity wtih focal loss of outermost enamel (pits) <2 mm in diameter. [Dean = Severe]

6 Smooth surfaces: Pits are regularly arranged in horizontal bands <2 mm in vertical extension.Occlusal surfaces: Confluent areas <3 mm in diameter exhibit loss of enamel. Marked attrition. [Dean = Severe]

7 Smooth surfaces: Loss of outermost enamel in irregular areas involving <1/2 of entire surface.Occlusal surfaces: Changes in the morphology caused by merging pits and marked attrition. [Dean = Severe]

8 Smooth and occlusal surfaces: Loss of outermost enamel involving >1/2 of surface. [Dean = Severe] 9 Smooth and occlusal surfaces: Loss of main part of enamel with change in anatomic appearance of surface. Cervical rim of almost unafffected enamel is often noted. [Dean = Severe]