BRIEF RESUME OF THE INTENDED WORK:

6.1 NEED FOR THE STUDY:

Dental diseases have been a constant affliction on humanity since the dawn of recorded history. Of all the common chronic diseases, Dental caries is the most prevalent in human beings due to our ever-changing lifestyle and dietary habits which is heavily reliant on processed food stuff as it wasn’t as prevalent a problem in older times as it is now. It is considered a multifactorial disease now due to its numerous causes.

Dental caries affects individuals of all age groups, But children of young age groups, especially the ones who come from a socially disadvantaged background are more vulnerable to this disease due to the inaccessibility to dental services and the illiteracy that is usually accompanied with the social backwardness of this subpopulation irrespective of race, ethnicity, caste or culture. It can be safely stated that this subpopulation is at moderate to high risk of developing dental caries. Dental Caries can affect the overall psychological growth and development of growing children if left unchecked which makes the prevention of this dental disease all the more important. Anganwadi schools cater to the educational and health needs of the age group of 2 to 5. The prevention of dental caries in this age group will greatly affect the general wellbeing of the children as poor oral health has a major influence on growth and cognitive ability of the child by affecting nutrition, concentration and consequent school participation.¹

Dental caries prevention has been an avenue where multiple studies have been conducted. In recent times, the studies including silver diamine fluoride and fluoride varnishes have been particularly of great interest due to the promising results shown by both materials and also the different therapeutic and preventive affects they provide respectively.

Fluorides have been heavily studied and have been the foundation of preventive dentistry for a while now; the systemic or topical usage of fluorides has been used successfully over the years in the reduction of dental caries incidence. The use of systemic fluorides in a community or school based water fluoridation programme is not very practiced in India which makes the topical application of fluoride varnishes in younger age groups the best possible way to provide fluoride base prevention to dental caries. It has many advantages over other materials like ease of handling, easy application, less prone to protocol modification, less prone to ingestion among children and affordability to be used in a large scale preschool children programme with the only major drawback being its inability to be used on teeth already affected by dental caries.³

Silver diamine fluoride on the other hand has also given excellent results when used as a method to arrest dental caries and also its antibacterial uses mainly due to its non-invasive applications. The sclerotic or calcium dentin formation due to silver salt stimulation, silver nitrates potent antibacterial effect added to fluorides ability to stop reduce susceptibility to decay makes this one of the best materials out there in the field of dental caries prevention³. A lower concentration of 12% is also available, but it is not as effective as 38% in arresting dental caries in children⁴. It’s only reported drawback is the staining of the carious lesions that it is applied onto. But its ease of application, affordability also adds to suitability as the go to preventive intervention of the future⁵.

Hence, Study will be conducted to assess the effectiveness of silver diamine fluoride and fluoride varnish in the arrest and prevention of dental caries among Anganwadi children.

As there is an abundance of literature on the use of Fluoride varnish as a community level dental caries prevention material, This study is being conducted to provide the same for the use of Silver diamine fluoride at a community level because of its cost effectiveness and ability to arrest caries in a simple manner which will be children friendly without the need for any tooth preparation, loss of intact tooth structure and using minimal instrumentation.

6.2 REVIEW OF LITERATURE:

1)        Chu C H, Lo E C M, Lin H C (2002)⁹conducted a prospective control trial to assess Effectiveness of Silver Diamine Fluoride (SDF) and Sodium Fluoride Varnish (NaF) in Arresting Dentin Caries in Chinese Pre-school Children. 375 Children from 8 preschools were selected to be in the study and randomized into 5 groups. First group caries was excavated and SDF applied, Second group had only SDF applied, third underwent excavation and NaF applied, fourth group had NaF applied and the fifth group was the control. One-way analysis of variance (ANOVA) was done to assess the differences found among the five treatment groups regarding the children’s mean age, DMFS scores and number of decayed tooth surfaces of the upper anterior teeth, and number of non-vital teeth at the baseline examination. The mean baseline DMFS score of the upper anterior teeth of the 308 children who were followed up for 30 months was 4.66. Their mean number of tooth surfaces with active caries at baseline was 3.92. The differences in the above parameters between the initial group of 375 children and the 308 children who remained in the study were not statistically significant (p > 0.05). There were also no statistically significant differences (ANOVA, p > 0.05) among the five groups of children in any of the above parameters. The 30-month results of this study showed that the annual application of silver diamine fluoride solution is effective in arresting dentin caries in primary anterior teeth in Chinese preschool children.

2)        Oliveira B H, Salazar M, Carvalho D M, Falcao A, Campos K, Nadanovsky P (2014)¹⁰ conducted a randomized control trial to assess whether the application of FV in preschool children at 6-month intervals decreases the incidence of caries and produces any adverse effects. A randomized, examiner- and patient-blind, placebo-controlled, parallel-group design, clinical trial, comprising 1- to 4-year-old children, 100 in each group (FV or placebo varnish, PV), was conducted in Rio de Janeiro, Brazil. A total of 32 (35.9%) children in the FV group and 43 (46.7%) in the PV group presented new dentine caries lesions (χ 2 test; p = 0.14), showing relative and absolute risk reductions of 23% (95% CI: –9.5 to 45.9) and 11% (95% CI: –3.5 to 25.0). The mean caries increment differences between the test and control groups were –0.8 (95% CI: –2.0 to 0.4) at the d 2level and –0.7 (95% CI: –1.9 to 0.4) at the d 3 level. The results of the study concluded that although safe and well accepted, twice-yearly FV application, during 2 years, did not result in a significant decrease in caries incidence.

3)        Shah S G, Bhaskar V, Chawla S, Venkataraghavan K, Prashant C, Ganesh M, Trivedi K (2014)²conducted a study to compare the efficacy of SDF as a topical fluoride agent in vivowith fluoride varnish and acidulated phosphate fluoride gel. A total of 123 children of age group 6 to 9 took part in the study and divided into three groups with the 3 respective treaments under the study.  All Subjects were evaluated through decayed, missing, and filled surface (DMFS) + DMFS index at 6th, 12th and 18th month as well as fluoride content in enamel at 6^th month of follow-up. Significant increase in fluoride content of enamel was found in Group 1 when compared with Group 2 and 3, whereas no significant difference was found between Group 2 and 3. Reduction in dental caries found in all groups but inter group comparison shows no significant difference. In vivo application of SDF on enamel significantly increases fluoride content in enamel as compared to Fluoride Varnish and APF Gel and can be used effectively as topical fluoride agent.

4)        Memarpour M, Dadaein D, Fakhraei E, Vossoughi M (2016)¹¹conducted a randomized control trial to evaluate the efficacy of oral health education and a fluoride varnish in the prevention of caries in children under the age of 3 years. For this single blind randomized parallel group 1-year clinical trial in Shiraz, 300 children aged 12–24 months with sound primary teeth were selected and randomly divided into three groups. At baseline and 4, 8 and 12 months after the intervention, caries risk reduction was recorded as the primary outcome. The mothers’ knowledge and performance regarding oral health in children was used as a secondary outcome. A total of 260 children completed the study. Compared to group 1, caries risk reduction in group 2 was 28% (95% CI: –39.05 to –17.45) and 31% in group 3 (95% CI: –41.88 to –21.73). However, there was no significant difference between groups 2 and 3 (95% CI: –8.58 to 1.47). In all groups, mother’s knowledge and performance at baseline were low; however, they increased significantly in follow-up appointments in groups 2 and 3 (p < 0.001). Oral health education increased knowledge and performance regarding oral health in children. Oral health counseling alone or associated with the use of fluoride varnish reduced the caries incidence in young children.

5)        Anderson M, Dahllof G, Soares F C, Grindefjord M (2017)¹²conducted a randomized control trial to describe caries progression at tooth surface level in children from 1-3 years of age and the impact of biannual treatment with fluoride varnish. 801 children who participated in a cluster-randomized controlled trial and had shown signs of dental caries were included in this study. International Caries Detection and Assessment System (ICDAS) was used to classify dental caries. The present study compared children receiving a standard yearly intervention to children receiving the same standard preventive intervention supplemented with an application of fluoride varnish every half year. The maxillary incisors were the first teeth to develop cavitation (ICDAS 3–6) and also mostly affected. Further analyses focusing on maxillary incisors buccal surfaces showed that sound surfaces had least progression and that progression to extensive decay was more common in teeth that had exhibited moderate decay. A summarizing progression index (PI) was calculated for the buccal surfaces of the maxillary incisors. Between 1 and 2 years of age PI was 26% and between 2 and 3 years of age PI was 21%. The progression on buccal incisors and on occlusal surface of first primary molars did not differ between intervention groups (p<0.05). The result of the study concluded that using fluoride varnish as a complement to standard intervention in toddlers did not add in the prevention of dental caries or its progression.

6)        Patil S K, Fatangare M, Jadhav R G, Shinde G R, Pawar S S and Kathariya M D (2018)¹³ conducted a randomized control trial to evaluate the efficacy of intensive application of sodium fluoride varnish in reducing caries incidence among children aged 6 to 7 years of Sangamner, Maharashtra, India. Nearly 200 randomly selected children were randomized into two groups: Control group and intervention (varnish) group. Dental examination to record the caries experiences was conducted at baseline and at 1-year follow-up. The fluoride varnish was applied for three times in a week for a period of 1 year. Mean DMFT were compared between and within groups using t-test. There was a statistically significant difference between the baseline and follow-up caries levels in varnish group for deciduous dentition. Mean caries reduction in this study was 26%. After 1 year of study, we found significant caries reversal in deciduous dentition among the 6- to 7-year-olds after intensive fluoride application. The result of the study concluded that Sodium fluoride varnish can be effective in the reduction of caries occurrence.

6.3 OBJECTIVE OF THE STUDY:

1.      To evaluate the effectiveness of 38% Silver Diamine Fluoride in the prevention and arrest of dental caries among Anganwadi children.

2.      To evaluate the effectiveness of 5% Sodium Fluoride Varnish in the prevention of dental caries among Anganwadi children

3.      To compare the effectiveness of 38% Silver Diamine fluoride and 5% Sodium Fluoride Varnish in the prevention of formation of new carious lesions among Anganwadi children at baseline and at 18 months.

7. METHODOLOGY:

7.1 TRIAL DESIGN:

A randomized, single blind trial among Anganwadi children will be designed.

Consolidated Standards of Reporting Trials 2010 Statement will be followed.

The flowchart of this study is shown in fig 1

7.2 SETTING:

Anganwadi children aged 3 - 3.5 years who have decayed teeth will be invited to be a part of the study. Permission to conduct the study will be obtained from The Deputy Director, Women and Children welfare (Annexure 1). Written parental consent will be obtained before they are included in the trial. The children included in the study should:

1)   Be aged 3 - 3.5 years.

2)   Be generally healthy

3)   Have parental consent (Annexure 2)

4)   Should have at least 1 tooth with untreated active carious lesion(s), extending into the dentin at baseline examination.

The exclusion criteria are:

1)   Children who are uncooperative and difficult to manage.

2)   Children with carious lesions involving the pulp on clinical examination.

3)   Children with medical history of systemic disease, drug allergy, congenital physical or mental disabilities and dental anomalies.

4)   Children with history of Silver allergy.

5)   Children suffering from Ulcerative gingivitis or stomatitis.

7.3 RECRUITMENT AND SCREENING:

Oral health education will be provided to the children and parents, followed by baseline oral examination. Clinical examination of the participating children will be done by a single calibrated examiner, using a mouth mirror and WHO Community Periodontal Index probe.

Nyvads caries diagnostic criteria will be used to assess the carious lesions.⁶

The carious lesion will be generally explored with the CPI probe in the center of the lesion only when required. Mixed lesions containing both active and inactive lesions were diagnosed as active.

A lesion will be recorded as active if softness is detected upon general probing, if the dentin surface is hard on probing, it will be classified as an inactive lesion. Active caries at the baseline that become inactive during follow up examinations will be used as the main treatment outcome.

The data will be collected according to the proforma (Annexure 3)

7.4 RANDOMIZATION AND TREATMENT ALLOCATION:

Anganwadi centers close to the research institute will be chosen, they will be numbered in an alphabetical order. Using lottery method, equal number of centers will be picked which will be allotted to:

Group A: Oral prophylaxis and Biannual application of 38% Silver Diamine Fluoride.

Group B: Oral prophylaxis, treatment and biannual application of 5% Sodium Fluoride Varnish.

7.5 BLINDING:

This will be a single blinded Randomized Control Trial.

The Biostatistician will be blinded here.

7.6 ARMAMENTARIUM USED FOR THE STUDY:

1) Plane mouth mirrors

2) CPI Probes

3) Tweezers

4) Kidney trays

5) Instrument trays

6) Cotton holder

7) Disposable gloves

8) Disposable mouth masks

9) Disposable glasses

10) Proformas

11) Torch

12) Hand wash

13) Hot water sterilizer

14) Sterile gauze

15) 2%Glutaraldehyde

16) Silver Diamine Fluoride (Fagamin38%)

17) Sodium Fluoride varnish (Duraphat 5%)

18) Microbrushes

19) Plastic dappen dishes

7.7 INTERVENTION:

SILVER DIAMINE FLUORIDE APPLICATION PROTOCOL⁷

1)         Standard personal protective equipment is used for patient and provider.

2)         One drop of Silver diamine Fluoride (SDF) will be taken into a plastic dappen dish. 

3)         Tongue and cheek will be isolated from affected teeth with 2-inch cotton rolls. 

4)         If near the gingiva, petroleum jelly will be applied for safety.

5)         Affected tooth surfaces will be dried with cotton.

6)         Microsponge is bent, immersed into SDF and excess removed on side of dappen dish.

7)         SDF will be directly applied onto the affected tooth surface(s) with microsponge.

8)         SDF is allowed to absorb for up to one minute, excess will be removed with cotton roll and then rinsed with water.

9)         Gloves and cotton will be put into plastic waste bags.

SODIUM FLUORIDE (NaF) VARNISH APPLICATION PROTOCOL⁸

(After Carious lesions are restored)

1)         Initially, cleaning and polishing of teeth is done.

2)         The upper and lower quadrants are dried thoroughly and isolated with cotton rolls.

3)         0.3 to 0.5 ml of 5% Sodium Fluoride varnish is applied with cotton applicators and allowed to dry for 4 minutes.

4)         Application is done first on the lower arch and then on the upper arch, using a single tufted small brush, starting with the proximal surfaces.

5)         After application, patient is made to sit with mouth open for 4 minutes before spitting to let Duraphat set on teeth which is further enhanced by saliva, patient is asked not to drink anything or rinse for 60 minutes and not to eat anything solid but take liquids and semisolids only till the next morning.

7.8 STERILIZATION:

The instruments will be sterilized using an autoclave.

The used instruments will be washed and disinfected using 2% Glutaraldehyde solution and autoclaved.

7.9 FOLLOW UP AND EVALUATION:

Follow up will be conducted at 6, 12 and 18 months using the same interventions and dentition will be evaluated at baseline and 18 months using Nyvads caries diagnostic criteria.

7.10 OUTCOME MEASURES:

The outcome includes clinically evaluated prevention of formation of new carious lesions after 18 months.

7.11 SAMPLE SIZE CALCULATIONS:

t tests - Means: Difference between two independent means (two groups)

Analysis:                                              A priori: Compute required sample size

Input:    Tail(s)                                     =  Two

               Effect size d                           =  0.45

               α err prob                                =  0.05

               Power (1-β err prob)               =  0.80

               Allocation ratio N2/N1          =  1

Output: Noncentrality parameter δ      =  2.828206

               Critical t                                 =  1.975288

               Df                                           =  156

               Sample size group 1              =  79

               Sample size group 2              =  79

               Total sample size                   =  158

               Actual power                          =  0.802558

A power analysis was established by G*power, version 3.0.1(Franz Faul universitat, Kiel, Germany). A sample size of 158 subjects which is rounded off to 160 (80 in each group) would yield 80% power to detect significant differences, with effect size of 0.45 and significance level at 0.05. A sample size of 200 (100 in each group) will be considered for the study to account for the loss of attrition

7.12 STATISTICAL ANALYSIS:

Data will be entered in the excel spread sheet. Descriptive statistics like mean, standard deviation and percentages will be calculated. Inferential statistics like Chi-square test, Mc Nemers test, paired and unpaired t test will be used to find out the statistical difference between two groups for arrest of dental caries using SPSS (Statistical Package for Social Sciences) version 20 (IBM SPSS statistics [IBM corp. released 2011] The analysis will be done based on Intent to treat analysis. Any other necessary tests will be dealt at the time of analysis based on data distribution.

7.13   FLOW CHART

ENROLLMENT                   Assessed for eligibility

Excluded if subjects:

·      are uncooperative

·      have history of systemic illness

·      have carious lesions involving the pulp

                                                   Randomized (n = 200)

      Group A                                         Allocation                                                 Group B

  38% SDF applied                                                                             Carious lesions treated

                                                                                                      and 5% NaF Varnish applied.

Dentition assessed and            Follow up (6,12 and 18 months)         Dentition assessed and              

 application repeated                                                                               application repeated

Lost to follow up (give reason) ( n=)                                 Lost to follow up (give reason) (n=)

Discontinued intervention (give reason) (n=)      Discontinued intervention (give reason)(n=)

       Analyzed                                          Analysis                                               Analyzed

                                                        Fig 1

7.14 Does the study require any investigations or interventions to be conducted on patients or other humans or animals?

Yes

7.15 Has ethical clearance been obtained from your institution in case of 7.14?

Yes ( AJEC/REV/239/2018 )

REFERENCES:

1)   Kashetty MV, Patil S, Kumbhar S, Patil P.Prevalence of dental caries among 3–6‑year‑old Anganwadi children in Mudhol town, Karnataka, India. J Indian Assoc Public Health Dent2016;14:403-8

2)   Swapnil K Patil, Madhura Fatangare, Rutuj G Jadhav, Gaurav R Shinde, Siddhi S Pawar, Mitesh D Kathariya Caries Preventive Effect of Sodium Fluoride Varnish on Deciduous Dentition: A Clinical Trial J Contemp Dent Pract 2017;18(12):1-4.

3)   Rajendra A, Veitz-Keenan A, Oliveira BH, Ruff RR, Wong MCM, Innes NPT, Radford J, Seifo N, Niederman R. Topical silver diamine fluoride for managing dental caries in children and adults. Cochrane Database of Systematic Reviews 2017, Issue 7. Art. No.: CD012718. DOI: 10.1002/14651858.CD012718.

4)   Galui S, Pal S, Pabale SL, Saha S, Sarkar S. Stretching new boundaries of caries prevention with silver diamine fluoride: A review of literature. Int J Pedod Rehabil 2018;3:1-4.

5)   Shah SG, Bhaskar V, Chawla S, Venkataraghavan K, Choudhary P, Ganesh M, et al. Efficacy of silver diamine fluoride as a topical fluoride agent compared to fluoride varnish and acidulated phosphate fluoride gel: An in vivo study. J Pediatr Dent 2014;2:5-12.

6)   B. Nyvad, V Machiulskiene, V Baelum. Reliability of a New Caries Diagnostic System Differentiating between Active and Inactive Lesions. Caries Res 1999;33:252-260

7)   California Dental Association Journal. Volume 44, Number 1, page no 24.

8)   Essentials of Preventive and Community Dentistry, Sober Peter, 4^th Edition, Page no 256