1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [aparna9h@gmail.com].
   


6. For how long will this data be available start date provided 01-12-2021 and end date provided 31-12-2022?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

This clinical study will be conducted in the Department of Pediatric and Preventive dentistry, Sharavathi Dental College & Hospital, Shimoga on a total of 72 school children of Shimoga city, belonging to age group of 6 to 9 years to evaluate caries arresting efficacy of 38 % Silver Diamine Fluoride solution over 5% Sodium Fluoride varnish.

Materials :

v     38% SDF- commercially available as FAgamin. (Tedequim, Argentina)

v     5% NaF varnish- commercially available as Fluoritop SR Varnish. (ICPA Health Products Ltd, India)

Armamentarium:

v    Mouth mirror

v     Community Periodontal Index of Treatment Needs (CPITN) probe

v     Tweezers

v     Dappen dish

v     Cotton rolls

v     Cotton tipped applicators

Tools

1.      Questionnaire for the parent/ guardian

2.      Visual analog scale for the participants

Examination

Oral examination will be conducted using mouth mirror and CPITN probe. Dental caries status will be evaluated using visual tactile examination and International Caries Detection and Assessment System (ICDAS) index.

International Caries Detection and Assessment System

ICDAS is a clinical scoring system that is used to detect and assess dental caries. ICDAS II system have two digit coding for detection criteria of dental caries. The first one is related to the restoration of teeth and has a coding that ranges from 0-9 and second digit represented coding for coronal primary caries ranging from 0-6 .

Table 1: The description of the first digit that is used restoration / sealant coding system of ICDAS II

Table 2: Description of the second digit that is used for coding the coronal primary caries in ICDAS II

Inclusion criteria

·         Participants of age 6 to 9 years.

·         Index teeth to be evaluated are primary molars and first permanentmolars.

·         Children with presence of minimum 1 carious lesion as defined by International Caries Detection and Assessment System(ICDAS).

·         Carious lesions with ICDAS code 1, 2 and 3.

Exclusion criteria

·         Children with acute, spontaneous pain due to caries, any sign of pulpal or periapicalinfection.

·         Teeth with arrested caries atbaseline.

·         Teeth with caries under restorations i.e. secondarycaries.

·         Children with severe medical condition, whose management will not be possible in dental clinic.

·         Children with hereditary developmental defects, known allergies or hypersensitivity reactions to dental materials.

·         Children with inability to cooperate for the current study or return for recall visits at anypoint.

Procedure

Institutional ethical approval is obtained from ethics committee (Ref no: SDC/SMG/2018/570).Before study participation, informed consent will be obtained from the child’s parent or the guardian. Assent will be obtained from all the participants. Parents will be provided with information about 38% SDF and 5% NaF varnish, follow up instructions, oral hygiene instructions and diet education. Information on the child’s snacking habits, dental visit history oral hygiene habits; tooth brushing, flossing etc. will be recorded. Participants’ demographic profile like age, sex, education, school information will be recorded.

Participants for the study will be taken from the outpatient of Department of Pediatric and Preventive Dentistry, Sharavathi Dental College and Hospital, Shimoga.

After baseline examination, considering inclusion and exclusion criteria the participants will be randomly divided equally into 2 groups with 36 children in each; group A- 38% SDF application and group B- 5% NaF application. In both the groups only those carious lesions with ICDAS score 1, 2 or 3, present on index teeth at baseline will be considered during the re application procedures. The follow up examinations will be carried out at 8 weekly intervals for 6 months. The same equipment, diagnostic criteria and treatment procedures will be used in all follow up visits.

Application of 38% SDF solution: 38% Silver Diamine Fluoride commercially available as FAgamin (Tedequim, Argentina) will be used for the study. Before starting the procedure, the mucosal surface near the index teeth will be covered with Vaseline petroleum jelly (Unilever Vaseline, United States) to protect it from pigmentation. Isolation of the teeth will be done using cotton rolls and high-volume suction. No attempt will be made to remove the caries. Tooth surfaces will be cleaned to establish the direct contact of carious tooth surface with 38% SDF solution. 38 % SDF will be applied using cotton applicator tips on the identified carious lesion on the primary molars and first permanent molars for 2 minutes and the excess will be wiped off.

Application of 5% NaF varnish: 5% Sodium fluoride varnish commercially available as Fluoritop SR dental varnish, manufactured by ICPA Health Products Limited, will be applied as per the manufacturer’sinstructions. Isolation of the teeth will be done using cotton rolls and high-volume suction. No attempt will be made to remove the caries. Tooth surfaces will be cleaned to establish the direct contact of carious tooth surface with 5% NaF solution. 5% NaF will be applied using cotton applicator tips on the identified carious lesion on the primary molars and first permanent molars for 2 minutes and the excess will be wiped off.

Furthermore, the patients will be instructed not to rinse, drink or eat for at least 1 hour and to take liquid or semisolid diet for that day.

At the baseline, caries will be measured for each tooth with ICDAS index. Primary molars and first permanent molars with ICDAS code 1 to 3 will be included for the study. The ICDAS code of index teeth will be noted down for evaluation purposes. Also, color and texture of the lesion will be noted. Topical fluoride; 38% SDF and 5% NaF, application will be done in respective groups.

The fluoride application for both the groups will be done 8^th weekly and recalled and reevaluated at baseline, 2^nd month, 4^th month and 6^th month.

At baseline and each recall visit, treated lesions will be assessed for

1.   Dentine color

2.   Lesion texture

3.   Presence or absence of pain or infection

At the 2^nd, 4^th and 6^th month follow up the index teeth will be reevaluated using visual tactile examination using CPITN probe and ICDAS index for both Group A and B. A note will be made on number of arrested lesions. Topical fluoride; 38% SDF or 5% NaF, will be reapplied on the index teeth with active caries, in the respective groups. Presence or absence of new caries, any acute symptoms, swelling or fistulas will be examined.

Child’s behavior will be recorded as cooperative or uncooperative. Child’s acceptability of the topical fluoride agent will be noted using a Smiley scale. After the fluoride application every child will be asked to evaluate the taste by choosing the appropriate smiley face. Each time smiley scale will be arranged on the table in the same order and at distance from the child.

Parental acceptability will be measured using a Likert scale questionnaire. The questionnaire will be created specifically to rate their acceptability of fluoride application.