ASSESSMENT OF SILVER DIAMINE FLUORIDE AND FLUORIDE VARNISH APPLICATION ON OBSTRUCTION AND HALT OF DENTAL DECAY AMONG PRE SCHOOL CHILDREN OF ANGANWADI CENTRES IN MANGALORE CITY
- Conditions
- Dental Caries Prevention and Arrest
- Registration Number
- CTRI/2019/02/017590
- Lead Sponsor
- Rasheed Minhaz
- Brief Summary
BRIEF RESUME OF THEINTENDED WORK:
**6.1NEED FOR THE STUDY:**
Dental diseaseshave been a constant affliction on humanity since the dawn of recorded history.Of all the common chronic diseases, Dental caries is the most prevalent inhuman beings due to our ever-changing lifestyle and dietary habits which isheavily reliant on processed food stuff as it wasn’t as prevalent a problem inolder times as it is now. It is considered a multifactorial disease now due toits numerous causes.
Dental caries affects individuals of all age groups, Butchildren of young age groups, especially the ones who come from a sociallydisadvantaged background are more vulnerable to this disease due to theinaccessibility to dental services and the illiteracy that is usuallyaccompanied with the social backwardness of this subpopulation irrespective ofrace, ethnicity, caste or culture. It can be safely stated that thissubpopulation is at moderate to high risk of developing dental caries. DentalCaries can affect the overall psychological growth and development of growingchildren if left unchecked which makes the prevention of this dental diseaseall the more important. Anganwadi schools cater to the educational and health needsof the age group of 2 to 5. The prevention of dental caries in this age groupwill greatly affect the general wellbeing of the children as poor oral healthhas a major influence on growth and cognitive ability of the child by affectingnutrition, concentration and consequent school participation.1
Dental caries prevention has been an avenue where multiplestudies have been conducted. In recent times, the studies including silverdiamine fluoride and fluoride varnishes have been particularly of greatinterest due to the promising results shown by both materials and also thedifferent therapeutic and preventive affects they provide respectively.
Fluorides have been heavily studied and have been thefoundation of preventive dentistry for a while now; the systemic or topicalusage of fluorides has been used successfully over the years in the reductionof dental caries incidence. The use of systemic fluorides in a community orschool based water fluoridation programme is not very practiced in India whichmakes the topical application of fluoride varnishes in younger age groups thebest possible way to provide fluoride base prevention to dental caries. It hasmany advantages over other materials like ease of handling, easy application,less prone to protocol modification, less prone to ingestion among children andaffordability to be used in a large scale preschool children programme with theonly major drawback being its inability to be used on teeth already affected bydental caries.3
Silver diamine fluoride on the other hand has also givenexcellent results when used as a method to arrest dental caries and also itsantibacterial uses mainly due to its non-invasive applications. The scleroticor calcium dentin formation due to silver salt stimulation, silver nitratespotent antibacterial effect added to fluorides ability to stop reducesusceptibility to decay makes this one of the best materials out there in thefield of dental caries prevention3.A lower concentration of 12% is also available, but it is not as effective as38% in arresting dental caries in children4. It’s only reported drawback is the staining of the carious lesions thatit is applied onto. But its ease of application, affordability also adds tosuitability as the go to preventive intervention of the future5.
Hence,Study will be conducted to assess the effectiveness of silver diamine fluorideand fluoride varnish in the arrest and prevention of dental caries amongAnganwadi children.
Asthere is an abundance of literature on the use of Fluoride varnish as acommunity level dental caries prevention material, This study is beingconducted to provide the same for the use of Silver diamine fluoride at acommunity level because of its cost effectiveness and ability to arrest cariesin a simple manner which will be children friendly without the need for any toothpreparation, 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)9**conducted a prospective control trial to assess Effectiveness ofSilver Diamine Fluoride (SDF) and Sodium Fluoride Varnish (NaF) in ArrestingDentin Caries in Chinese Pre-school Children. 375 Children from 8 preschoolswere selected to be in the study and randomized into 5 groups. First groupcaries was excavated and SDF applied, Second group had only SDF applied, thirdunderwent excavation and NaF applied, fourth group had NaF applied and thefifth group was the control. One-way analysis of variance (ANOVA) was done toassess the differences found among the five treatment groups regarding thechildren’s mean age, DMFS scores and number of decayed tooth surfaces of theupper 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 childrenwho were followed up for 30 months was 4.66. Their mean number of toothsurfaces with active caries at baseline was 3.92. The differences in the aboveparameters between the initial group of 375 children and the 308 children whoremained in the study were not statistically significant (p > 0.05). Therewere also no statistically significant differences (ANOVA, p > 0.05) amongthe five groups of children in any of the above parameters. The 30-monthresults of this study showed that the annual application of silver diaminefluoride solution is effective in arresting dentin caries in primary anteriorteeth in Chinese preschool children.
**2)****Oliveira B H, Salazar M, Carvalho D M, Falcao A, Campos K,Nadanovsky P (2014)10** conducted arandomized control trial to assess whether the application of FV in preschoolchildren at 6-month intervals decreases the incidence of caries and producesany adverse effects. A randomized, examiner- and patient-blind,placebo-controlled, parallel-group design, clinical trial, comprising 1- to4-year-old children, 100 in each group (FV or placebo varnish, PV), wasconducted in Rio de Janeiro, Brazil. A total of 32 (35.9%) children in the FVgroup and 43 (46.7%) in the PV group presented new dentine caries lesions (χ 2test; 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 incrementdifferences 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 ofthe study concluded that although safe and well accepted, twice-yearly FVapplication, during 2 years, did not result in a significant decrease in cariesincidence.
**3)****ShahS G, Bhaskar V, Chawla S, Venkataraghavan K, Prashant C, Ganesh M, Trivedi K(2014)2**conducted a study to compare the efficacy of SDF as atopical fluoride agent *in vivo*withfluoride varnish and acidulated phosphate fluoride gel. A total of 123 childrenof age group 6 to 9 took part in the study and divided into three groups withthe 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 aswell as fluoride content in enamel at 6th month of follow-up.Significant increase in fluoride content of enamel was found in Group 1 whencompared with Group 2 and 3, whereas no significant difference was foundbetween Group 2 and 3. Reduction in dental caries found in all groups but intergroup comparison shows no significant difference. *In vivo* application ofSDF on enamel significantly increases fluoride content in enamel as compared toFluoride Varnish and APF Gel and can be used effectively as topical fluorideagent.
**4)****Memarpour M, Dadaein D, Fakhraei E, Vossoughi M (2016)11**conducted a randomized control trial to evaluate the efficacy oforal health education and a fluoride varnish in the prevention of caries inchildren under the age of 3 years. For this single blind randomized parallelgroup 1-year clinical trial in Shiraz, 300 children aged 12–24 months withsound primary teeth were selected and randomly divided into three groups. Atbaseline and 4, 8 and 12 months after the intervention, caries risk reductionwas recorded as the primary outcome. The mothers’ knowledge and performanceregarding oral health in children was used as a secondary outcome. A total of260 children completed the study. Compared to group 1, caries risk reduction ingroup 2 was 28% (95% CI: –39.05 to –17.45) and 31% in group 3 (95% CI: –41.88to –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 atbaseline were low; however, they increased significantly in follow-up appointmentsin groups 2 and 3 (p < 0.001). Oral health education increased knowledge andperformance regarding oral health in children. Oral health counseling alone orassociated with the use of fluoride varnish reduced the caries incidence inyoung children.
**5)****Anderson M, Dahllof G, Soares F C, Grindefjord M (2017)12**conducted a randomized control trial to describe caries progressionat tooth surface level in children from 1-3 years of age and the impact ofbiannual treatment with fluoride varnish. 801 children who participated in acluster-randomized controlled trial and had shown signs of dental caries wereincluded in this study. International Caries Detection and Assessment System(ICDAS) was used to classify dental caries. The present study compared childrenreceiving a standard yearly intervention to children receiving the samestandard preventive intervention supplemented with an application of fluoridevarnish every half year. The maxillary incisors were the first teeth to developcavitation (ICDAS 3–6) and also mostly affected. Further analyses focusing onmaxillary incisors buccal surfaces showed that sound surfaces had leastprogression and that progression to extensive decay was more common in teeththat had exhibited moderate decay. A summarizing progression index (PI) wascalculated for the buccal surfaces of the maxillary incisors. Between 1 and 2years of age PI was 26% and between 2 and 3 years of age PI was 21%. Theprogression on buccal incisors and on occlusal surface of first primary molarsdid not differ between intervention groups (p<0.05). The result of the studyconcluded that using fluoride varnish as a complement to standard interventionin 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 andKathariya M D (2018)13** conducted arandomized control trial to evaluate the efficacy of intensive application ofsodium fluoride varnish in reducing caries incidence among children aged 6 to 7years of Sangamner, Maharashtra, India. Nearly 200 randomly selected childrenwere randomized into two groups: Control group and intervention (varnish)group. Dental examination to record the caries experiences was conducted atbaseline and at 1-year follow-up. The fluoride varnish was applied for threetimes in a week for a period of 1 year. Mean DMFT were compared between andwithin groups using t-test. There was a statistically significant differencebetween the baseline and follow-up caries levels in varnish group for deciduousdentition. Mean caries reduction in this study was 26%. After 1 year of study,we found significant caries reversal in deciduous dentition among the 6- to7-year-olds after intensive fluoride application. The result of the studyconcluded that Sodium fluoride varnish can be effective in the reduction ofcaries occurrence.
**6.3OBJECTIVE OF THE STUDY:**
1. To evaluate the effectivenessof 38% Silver Diamine Fluoride in the prevention and arrest of dental cariesamong Anganwadi children.
2. To evaluate the effectivenessof 5% Sodium Fluoride Varnish in the prevention of dental caries among Anganwadichildren
3. To compare the effectiveness of38% Silver Diamine fluoride and 5% Sodium Fluoride Varnish in the prevention offormation of new carious lesions among Anganwadi children at baseline and at 18months.
7. **METHO****DOLOGY:**
7.1 **TRIALDESIGN:**
Arandomized, single blind trial among Anganwadi children will be designed.
ConsolidatedStandards of Reporting Trials 2010 Statement will be followed.
Theflowchart of this study is shown in fig 1
**7.2SETTING**:
Anganwadichildren aged 3 - 3.5 years who have decayed teeth will be invited to be a partof the study. Permission to conduct the study will be obtained from The DeputyDirector, Women and Children welfare **(Annexure1).** Written parental consent will be obtained before they are included inthe trial. The children included in the study should:
1) Beaged 3 - 3.5 years.
2) Begenerally healthy
3) Haveparental consent **(Annexure 2)**
4) Shouldhave at least 1 tooth with untreated active carious lesion(s), extending intothe dentin at baseline examination.
Theexclusion criteria are:
1) Childrenwho are uncooperative and difficult to manage.
2) Childrenwith carious lesions involving the pulp on clinical examination.
3) Childrenwith medical history of systemic disease, drug allergy, congenital physical ormental disabilities and dental anomalies.
4) Childrenwith history of Silver allergy.
5) Childrensuffering from Ulcerative gingivitis or stomatitis.
**7.3 RECRUITMENTAND SCREENING:**
Oralhealth education will be provided to the children and parents, followed by baselineoral examination. Clinical examination of the participating children will bedone by a single calibrated examiner, using a mouth mirror and WHO CommunityPeriodontal Index probe.
**Nyvads cariesdiagnostic criteria will be used to assess the carious lesions.6**
Thecarious lesion will be generally explored with the CPI probe in the center ofthe lesion only when required. Mixed lesions containing both active andinactive lesions were diagnosed as active.
Alesion 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 inactivelesion. Active caries at the baseline that become inactive during follow upexaminations will be used as the main treatment outcome.
Thedata will be collected according to the proforma **(Annexure 3)**
**7.4 RANDOMIZATIONAND TREATMENT ALLOCATION:**
Anganwadicenters close to the research institute will be chosen, they will be numberedin an alphabetical order. Using lottery method, equal number of centers will bepicked 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:**
Thiswill be a single blinded Randomized Control Trial.
TheBiostatistician 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:**
**SILVERDIAMINE FLUORIDE APPLICATION PROTOCOL7**
1) Standard personalprotective equipment is used for patient and provider.
2) One drop of Silverdiamine Fluoride (SDF) will be taken into a plastic dappen dish. 
3) Tongue and cheek willbe isolated from affected teeth with 2-inch cotton rolls. 
4) If near the gingiva,petroleum jelly will be applied for safety.
5) Affected tooth surfaceswill be dried with cotton.
6) Microsponge is bent,immersed into SDF and excess removed on side of dappen dish.
7) SDF will be directlyapplied onto the affected tooth surface(s) with microsponge.
8) SDF is allowed to absorbfor up to one minute, excess will be removed with cotton roll and then rinsedwith water.
9) Gloves and cotton willbe put into plastic waste bags.
**SODIUMFLUORIDE (NaF) VARNISH APPLICATION PROTOCOL8**
**(AfterCarious lesions are restored)**
1) Initially, cleaning andpolishing of teeth is done.
2) The upper and lowerquadrants 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 dryfor 4 minutes.
4) Application is donefirst on the lower arch and then on the upper arch, using a single tufted smallbrush, starting with the proximal surfaces.
5) After application, patientis made to sit with mouth open for 4 minutes before spitting to let Duraphatset on teeth which is further enhanced by saliva, patient is asked not to drinkanything or rinse for 60 minutes and not to eat anything solid but take liquidsand semisolids only till the next morning.
7.8STERILIZATION:
The instruments will be sterilized using anautoclave.
The used instruments will be washed anddisinfected using 2% Glutaraldehyde solution and autoclaved.
**7.9 FOLLOW UPAND EVALUATION:**
Followup will be conducted at 6, 12 and 18 months using the same interventions and dentitionwill be evaluated at baseline and 18 months using **Nyvads caries diagnostic criteria**.
**7.10 OUTCOMEMEASURES:**
Theoutcome includes clinically evaluated prevention of formation of new cariouslesions after 18 months.
**7.11 SAMPLE SIZECALCULATIONS:**
**ttests -** Means: Difference between twoindependent 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:** Noncentralityparameter 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 byG\*power, version 3.0.1(Franz Faul universitat, Kiel, Germany). A sample size of158 subjects which is rounded off to 160 (80 in each group) would yield 80%power to detect significant differences, with effect sizeof 0.45 and significance level at 0.05. A sample size of 200 (100 in eachgroup) will be considered for the study to account for the loss of attrition
7.12 STATISTICAL ANALYSIS:
Data will be entered inthe excel spread sheet. Descriptive statistics like mean, standard deviationand percentages will be calculated. Inferential statistics like Chi-squaretest, Mc Nemers test, paired and unpaired t test will be used to find out thestatistical difference between two groups for arrest of dental caries usingSPSS (Statistical Package for Social Sciences) version 20 (IBM SPSS statistics[IBM corp. released 2011] The analysis will be done based on Intent to treatanalysis. Any other necessary tests will be dealt at the time of analysis basedon 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)*
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*Group A **Allocation** GroupB*
*38% SDF applied Cariouslesions treated*
*and 5%NaF Varnish applied.*
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*Dentitionassessed and **Follow up (6,12 and 18 months)** Dentition assessed and*
*application repeated application repeated*
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| --- | --- | --- | --- |
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*Lost to followup (give reason) ( n=) Lost to follow up(give reason) (n=)*
*Discontinued intervention(give reason) (n=) Discontinuedintervention (give reason)(n=)*
| | | | |
| --- | --- | --- | --- |
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*Analyzed **Analysis** Analyzed*
Fig 1
7.14 Does the study require anyinvestigations or interventions to be conducted on patients or other humans oranimals?
Yes
7.15 Has ethical clearance been obtained from your institution in case of7.14?
Yes ( AJEC/REV/239/2018 )
**REFERENCES:**
**1)** Kashetty MV, Patil S, Kumbhar S, PatilP.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, MadhuraFatangare, Rutuj G Jadhav, Gaurav R Shinde, Siddhi S Pawar, Mitesh D Kathariya CariesPreventive Effect of Sodium Fluoride Varnish on Deciduous Dentition: A ClinicalTrial J Contemp Dent Pract 2017;18(12):1-4.
**3)** Rajendra A, Veitz-Keenan A, Oliveira BH, Ruff RR, Wong MCM, InnesNPT, Radford J, Seifo N, Niederman R. Topical silver diamine fluoride formanaging dental caries in children and adults. *Cochrane Database ofSystematic Reviews* 2017, Issue 7. Art. No.: CD012718. DOI:10.1002/14651858.CD012718.
**4)** Galui S, Pal S, Pabale SL, Saha S, Sarkar S. Stretching newboundaries of caries prevention with silver diamine fluoride: A review ofliterature. Int J Pedod Rehabil 2018;3:1-4.
**5)** Shah SG, Bhaskar V, Chawla S, Venkataraghavan K, Choudhary P, GaneshM, *et al*. Efficacy of silver diamine fluoride as a topical fluorideagent compared to fluoride varnish and acidulated phosphate fluoride gel: An invivo study. J Pediatr Dent 2014;2:5-12.
**6)** B. Nyvad, V Machiulskiene, V Baelum. Reliability of a New CariesDiagnostic System Differentiating between Active and Inactive Lesions. CariesRes 1999;33:252-260
**7)** California Dental Association Journal. Volume 44, Number 1, page no24.
**8)** Essentials of Preventive and Community Dentistry, Sober Peter, 4thEdition, Page no 256
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
Anganwaadi Pre school children of age group 3 to 3.5 years with dental caries without involvement of the pulp.
Patients with dental caries involving pulp, patients with any systemic illness, patients with silver allergy, patients with ulcerative gingivitis or stomatitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Formation of new carious lesions will be assessed At the end of 18 months
- Secondary Outcome Measures
Name Time Method dental caries that has been arrested assessed after 18 months
Trial Locations
- Locations (1)
Anganawadi centre
🇮🇳Kannada, KARNATAKA, India
Anganawadi centre🇮🇳Kannada, KARNATAKA, IndiaPremalathaPrincipal investigator9740546519premalatha001234@gmail.com