| CTRI Number |
CTRI/2025/01/079154 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparing Silver Diamine Fluoride and Fluoride Varnish to Prevent Cavities in Young Children in Visnagar |
|
Scientific Title of Study
|
Effectiveness Of Silver Diamine Fluoride And Fluoride Varnish In Preventing Dental Caries In Primary Molars Among The Children Of 3-6 Year In Visnagar: A Randomised Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dimpal Parmar |
| Designation |
Senior Lecturer |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta, Visnagar, Gujarat
Mahesana
GUJARAT
384315
India |
| Phone |
8128447424 |
| Fax |
|
| Email |
drdimpalp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shoba Fernandes |
| Designation |
HOD & Professor |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta, Visnagar, Gujarat
Mahesana
GUJARAT
384315
India |
| Phone |
7567622346 |
| Fax |
|
| Email |
vshobaf@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dimpal Parmar |
| Designation |
Senior Lecturer |
| Affiliation |
Narsinhbhai Patel Dental College and Hospital |
| Address |
Department of Pediatric and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta, Visnagar, Gujarat
Mahesana
GUJARAT
384315
India |
| Phone |
8128447424 |
| Fax |
|
| Email |
drdimpalp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar
Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char
Rasta, Visnagar, Gujarat 384315 |
|
|
Primary Sponsor
|
| Name |
Dr Dimpal Parmar |
| Address |
A/21 SOMNATH SOCIETY, NEAR RABARI VASAHAT CANAL, ODHAV, AHMEDABAD, GUJARAT, INDIA, PINCODE-382415 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Dimpal Parmar |
Narsinhbhai Patel Dental College and Hospital |
Department of Pediatric and Preventive Dentistry, Narsinhbhai Patel Dental College and Hospital, S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta, Visnagar, Gujarat
Mahesana
GUJARAT |
8128447424
drdimpalp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NPDCH,SPU,Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with bilateral caries-free deciduous molars
This is a Preventive trial
As inclusion criteria of this study will be caries free child mouth, we cant select it under dental caries section |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fagamin- Silver Diamine Fluoride 38% |
It will be applied on the tooth-on one side of the arch with the micro brush -Biannually
This will be 1.8 year follow up study |
| Comparator Agent |
Fluoride Varnish |
It will be applied on the tooth-on opposite side of the arch with the micro brush -Biannually
This will be 1.8 year follow up study |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Children aged between 3-6 years
Children with bilateral caries-free deciduous molars
Children whose parent gives the written consent
|
|
| ExclusionCriteria |
| Details |
Children with the evidence of caries in deciduous molars
Children with special health care needs
Children with any systemic disease or premature birth
Children having developmental anomalies in the shape and size of teeth |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
This can prevent the progression of caries lesions to more advanced stages, reducing the need for invasive and costly treatments in the future.
|
1.8 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Development of evidence-based preventive care practices in pediatric dentistry.
Facilitate early intervention strategies for managing dental caries in young children. |
1.8 Years |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="8"
Days="0" |
|
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
|
This randomized controlled trial with split mouth study design
will include 84 children of age group 3-6 years having bilateral caries free
deciduous molars. In each patient, teeth will be
randomly divided in two groups in which SDF and Fluoride varnish application will be
done. Questionnaire regarding
demographic data, dietary habit, oral hygiene habit and socioeconomic status
will be administered to the parents. Bitewing radiograph will be
taken as a baseline record. Clinical examination will be done using
ICDAS Criteria and Bitewing radiograph will be taken
as a baseline record. SDF and Fluoride Varnish
application - with the help of Y shaped dental floss holder with floss and
micro brush (Group A and B). Biannual application - with the
follow up of 6, 12 and 18-months using bitewing radiograph. ICCMSâ„¢ (International Caries
Classification and Management System) method will be used for radiographic
assessment. Data will be entered in Microsoft excel and analyzed.
|