| CTRI Number |
CTRI/2025/05/086810 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparing silver diamine fluoride and sodium fluoride varnish in stopping the caries |
|
Scientific Title of Study
|
comparative evaluation of silver diamine fluoride and sodium fluoride varnish in arresting the caries: A Randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Tommandru Supriya |
| Designation |
Post graduate |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Bheemunipatnam
Visakhapatnam
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Bheemunipatnam
Visakhapatnam
531162
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
7981577894 |
| Fax |
|
| Email |
sahanya7t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.K.Chaitanya Ram |
| Designation |
Professor and Hod |
| Affiliation |
Anil Neerukonda Institute of Dental Sciences |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Bheemunipatnam
Visakhapatnam
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Bheemunipatnam
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9493120291 |
| Fax |
|
| Email |
fauchard2612@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.T.Supriya |
| Designation |
Post graduate |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Bheemunipatnam
Visakhapatnam
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Bheemunipatnam
Visakhapatnam
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
7981577894 |
| Fax |
|
| Email |
sahanya7t@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anil Neerukonda Institute Of Dental Sciences Visakhapatnam |
|
|
Primary Sponsor
|
| Name |
Dr Tommandru Supriya |
| Address |
Anil Neerukonda Institute of Dental Sciences
Sangivalasa
Bheemunipatnam
Visakhapatnam
531162 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrTommandru Supriya |
Anil neerukonda institute of dental sciences |
Department of pediatric and preventive dentistry
Room no.7
sangivalasa
pincode:531162
Visakhapatnam
ANDHRA PRADESH |
7981577894
sahanya7t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR TOMMANDRU SUPRIYA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
silver diamine fluoride |
effectiveness of silver diamine fluoride in arresting caries |
| Comparator Agent |
sodium fluoride varnish |
effectiveness of sodium fluoride varnish in arresting caries |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.children aged 6-12 years with parental or guardian acceptance and cooperation.
2. Children with active carious lesions in either primary,mixed dentition
3. Patient with good general health and free of any systemic diseases.
4. Children with no allergic reactions to silver. |
|
| ExclusionCriteria |
| Details |
1. Children with developmental dental abnormalities such as enamel defects.
2. Children with known silver allergy.
3. Tooth with physiologic root resorption or close to exfoliation.
4. Children with extensive caries involvement, including pulpal involvement, pain, mobility, abscess formation, sinus, or fistula.
5. Children with special health care needs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The comparative evaluation of Silver diamine fluoride and sodium fluoride varnish will give an appropriate material in arresting caries progression. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Caries Recurrence
tooth discoloration
treatment acceptability
cost effectiveness |
at 3, 6 & 9 month interval |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
• A randomized control study will be conducted among children aged 6-12 years residing in government hostel Visakhapatnam, suburban district, Andhra Pradesh. Prior to the study written informed consent would be taken from the parents of the children. • children who fulfilled the inclusion criteria will be included in the study. • A preoperative bitewing radiograph is taken to all the children undergoing the study • In Group 1, steps of 38 percent SDF(kedo 38 percent SDF with KI) application: • Before doing the procedure any food debris and plaque if present should be removed from the cavities by wiping with wet gauze, carious lesions should not be removed. • Decayed teeth are isolated and should be kept dry with cotton rolls and gauze. • Place one drop of SDF in a plastic dappen dish and should be applied onto the carious tooth surfaces with a micro- applicator for 1 minute ,then apply potassium iodide. Remove any excess by gentle blotting using a cotton pellet. • The children are instructed to avoid drinking, eating or rinsing in the next 30 minutes after the application. • The children will be recalled at 3,6 and 9month intervals and evaluated for caries arrest with the help of a post operative bitewing radiograph. • A dfs index and post operative bitewing radiograph is used to record and assess the prevalence of dental caries in children. • In Group 2, steps of 5 percent NaF varnish(voco profluoride varnish) application: • Before the procedure Any food debris and plaque if present,should be removed from the tooth surfaces thoroughly by wiping with wet gauze. • We should Isolate the decayed teeth and keep it dry with cotton rolls and gauze. • A thin coat of 5 percent NaF(voco proflouride) varnish should be applied using a suitable brush to carious teeth. • The children will be recalled at 3,6 and 9month intervals and evaluated for caries arrest with the help of a post operative bitewing radiograph. • A dfs index & post operative bitewing radiograph is used to record and assess the prevalence of dental caries in children. The children were instructed not to rinse, drink or eat for 2 hours and are asked to refrain from brushing on the same day |