| CTRI Number |
CTRI/2020/07/026877 [Registered on: 29/07/2020] Trial Registered Prospectively |
| Last Modified On: |
09/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Deep caries management |
|
Scientific Title of Study
|
Silver diamine fluoride for caries management in primary molars |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meenu Mittal |
| Designation |
Professor |
| Affiliation |
ESIC Dental College |
| Address |
Department of Pediatric Dentistry, ESIC Dental College,Sector 15, Rohini, Delhi
North
DELHI
110089
India |
| Phone |
9811840018 |
| Fax |
|
| Email |
meenu20feb@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenu Mittal |
| Designation |
Professor |
| Affiliation |
ESIC Dental College |
| Address |
Department of Pediatric Dentistry, ESIC Dental College,Sector 15, Rohini, Delhi
North
DELHI
110089
India |
| Phone |
9811840018 |
| Fax |
|
| Email |
meenu20feb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenu Mittal |
| Designation |
Professor |
| Affiliation |
ESIC Dental College |
| Address |
Department of Pediatric Dentistry, ESIC Dental College,Sector 15, Rohini, Delhi
North
DELHI
110089
India |
| Phone |
9811840018 |
| Fax |
|
| Email |
meenu20feb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ESIC Dental College |
| Address |
ESIC Dental College,Sector 15, Rohini, Delhi |
| Type of Sponsor |
Government 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 |
| Dr Meenu Mittal |
ESIC Dental College |
Department of Pediatric Dentistry,ESIC Dental College, Sector 15, Rohini, Delhi
North
DELHI |
9811840018
meenu20feb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESIC Dental College & hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Control- No medicament application,only stainless steel crown |
| Intervention |
silver diamine fluoride |
silver diamine fluoride application on carious lesions followed by stainless steel crowns |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Healthy cooperative dental patients presenting cavitated carious lesions involving dentin without pulp exposure in primary molars |
|
| ExclusionCriteria |
| Details |
History of spontaneous pain/ presence of abscess or fistula or abnormal mobility/ radiographic evidence of internal root resorption or peri-apical pathosis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical and radiological success of silver diamine fluoride in deep carious lesions |
1 month, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2020 |
| Date of Study Completion (India) |
30/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study was conducted in the Department of Pediatric & Preventive Dentistry, ESIC Dental College, Rohini, Delhi. Children in the age group of 4-8 years, presenting to the departmental clinic for dental treatment were screened, and those presenting clinically cavitated carious lesion involving dentin having soft caries in primary molar without pulp exposure were considered for participation in the study. Informed consent was obtained from each subject’s parents before enrolling them in study. Each child was randomly assigned to treatment group A or B by envelope method. The two groups divided were as follows: a) GROUP-A : (n=25) Control- Complete caries removal done and tooth restored with Stainless steel crown (SSC) b) GROUP-B: (n=25) Silver diamine fluoride applied followed by SSC using Hall technique. Follow up was done at 1 month, 3,6,12 months interval and treatment success or failure was determined by a combination of clinical and radiographic findings by an investigator blinded to the treatment groups. Radiographs were taken at 3months, 6 months and 12 months follow up visit. The differences in both the groups for clinical and radiographic parameters was statistically analysed- qualitative data using chi square test. Results: Combining clinical and radiological results for major failures, there was no statistically significant difference in both the groups. |