| CTRI Number |
CTRI/2024/04/066261 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
NANO SILVER FLUORIDE AND SDF WITH GLUTATHIONE TO EVALUATE CARIOSTATIC POTENTIAL AND DISCOLORATION- A COMPARATIVE STDUY |
|
Scientific Title of Study
|
COMPARISON OF NANO SILVER FLUORIDE AND SDF WITH GLUTATHIONE TO EVALUATE CARIOSTATIC POTENTIAL AND DISCOLORATION IN PRIMARY TEETH-A RANDOMIZED CONTROL 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 |
Akanksha Singh |
| Designation |
P.G Student |
| Affiliation |
Narsinhbhai Patel Dental college and Hospital, Sankalchand Patel University |
| Address |
SANKALCHAND PATEL UNIVERSITY
NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
BLOCK NO. 8
PG WARD
Mahesana
GUJARAT
384315
India |
| Phone |
7048216780 |
| Fax |
|
| Email |
akanksha199823@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR, SHOBA FERNANDES |
| Designation |
GUIDE |
| Affiliation |
Narsinhbhai Patel Dental college and Hospital, Sankalchand Patel University |
| Address |
NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
DEPARTMENT NO. 8
PG WARD
Mahesana
GUJARAT
384315
India |
| Phone |
7048216780 |
| Fax |
|
| Email |
pedo@npdch.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Akanksha Singh |
| Designation |
GUIDE |
| Affiliation |
Narsinhbhai Patel Dental college and Hospital, Sankalchand Patel University |
| Address |
NARSINHBHAI PATEL DENTAL COLLEGE AND HOSPITAL
DEPARTMENT OF PEDIATRIC AND PREVENTIVE DENTISTRY
DEPARTMENT NO. 8
PG WARD
Mahesana
GUJARAT
384315
India |
| Phone |
7048216780 |
| Fax |
|
| Email |
pedo@npdch.edu.in |
|
|
Source of Monetary or Material Support
|
| Narsinhbhai Patel Dental College and Hospital, Sankalchand Patel University
Visnagar, 384315
Gujarat
India |
|
|
Primary Sponsor
|
| Name |
Narsinhbhai Patel Dental college and Hospital |
| Address |
S. P. Sahakar Vidyadham, Ambaji Gandhinagar Link Road, Near Kamana Char Rasta, Visnagar, Gujarat 384315 |
| 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 |
| Dr Akanksha Singh |
Narsinhbhai Patel Dental college and Hospital, Sankalchand Patel University, Visnagar |
Department no. 8, Department of Pediatric and Preventive Dentistry, Narisnhbhai Patel Dental College and Hospital, Sankalchand Patel University, Visnagar, Gujarat 384315
Mahesana
GUJARAT
Mahesana
GUJARAT |
7048216780
akanksha199823@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K026||Dental caries on smooth surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nano Silver Fluoride (NSF) |
NSF will be used on carious lesion to assest the dental caries and photographic evaluation will be done to check the discoloration on the teeth |
| Comparator Agent |
SDF with Gluatathione |
Glutathione will be mixed in SDF in order to change its discoloration property and then photographic evaluation will be done |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1) Children aged between 4-9 years
2) Caries involving Enamel and only 1/3rd of Dentin
3) Patient with high to moderate caries risk
4)No periapical pathology
5) No pain
6) Study lesion must not require an invasive treatment
7) Patient willingly participating in the study with informed consent |
|
| ExclusionCriteria |
| Details |
1) Medically compromised children
2) Patient allergic to any material used in the study
3) Children participating in any other study
4) Any other restoration on the study tooth
5) Patient with low caries risk |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the cariostatic potential of the materials used |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Discoloration |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Dental caries is the most prevalent disease when it comes to oral health In children it is difficult to use the high speed machines in order to treat the dental caries In my study I will be using Nano silver Fluoride and SDF with Glutathione which have been known to have cariostatic potential but the drawback of using SDF is the black discoloration caused by it So the SDF is modified using Glutathione which will reduce the discoloration on the tooth and will be compared with Nanosilver Fluoride which has minimal discoloration |