| CTRI Number |
CTRI/2025/12/098940 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Three Fluoride Agents For Preventing Tooth Decay In Children |
|
Scientific Title of Study
|
Comparative Evaluation Of Cariostatic Efficacy Of 5% Nano silver Fluoride,38% Silver Diamine Fluoride,5% Sodium Fluoride Varnish On Primary Teeth In Children Of Age Group 4 To 8 Years With Incipient Carious Lesions – An In-Vivo Randomized Clinical 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 |
BHEEMA PRAVALIKA |
| Designation |
POST GRADUATE |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room No 8 Department of pedodontics and preventive dentistry MNR DENTAL COLLEGE MNR NAGAR FASALWADI MOHD SHAHPUR
Medak
TELANGANA
502294
India |
| Phone |
9059875550 |
| Fax |
|
| Email |
pappulapravalika12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SRIDHAR MUKTINENI |
| Designation |
PROFESSOR |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room No 8 Department of pedodontics and preventive dentistry MNR DENTAL COLLEGE MNR NAGAR FASALWADI,MOHD SHAHPUR
Medak
TELANGANA
502294
India |
| Phone |
9393812081 |
| Fax |
|
| Email |
sridharneni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NASEEMOON SHAIK |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
MNR DENTAL COLLEGE AND HOSPITAL |
| Address |
Room No 8 Department of pedodontics and preventive dentistry MNR DENTAL COLLEGE MNR NAGAR FASALWADI MOHD SHAHPUR
Medak
TELANGANA
502294
India |
| Phone |
8105935678 |
| Fax |
|
| Email |
dr.naseemoonshaik@gmail.com |
|
|
Source of Monetary or Material Support
|
| MNR DENTAL COLLEGE AND HOSPITAL Room No 8 Department of pedodontics and preventive dentistry MNR NAGAR FASALWADI MOHD SHAHPUR |
|
|
Primary Sponsor
|
| Name |
BHEEMA PRAVALIKA |
| Address |
Room No 8 Department of pedodontics and preventive dentistry MNR DENTAL COLLEGE MNR NAGAR FASALWADI MOHD SHAHPUR |
| 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 |
| BHEEMA PRAVALIKA |
GOVERNMENT HIGH SCHOOL |
GHS SHAIKPET, room no 1,500008
Hyderabad
TELANGANA |
9059875550
pappulapravalika12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MNR DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B949||Sequelae of unspecified infectiousand parasitic disease, (2) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
38% Silver Diamine Fluoride (SDF) |
The comparator material, 38% Silver Diamine Fluoride (SDF), is a chemical complex composed of silver, ammonia, and fluoride. It is applied to the affected tooth surface using a cotton pellet or micro brush for about 10 seconds, following the same protocol as the other agents. The silver component provides a strong antimicrobial effect, while fluoride aids in remineralization, effectively arresting the progression of dental caries. However, a notable drawback of SDF application is the black discoloration of the treated carious lesion, which may affect the esthetics, especially in anterior teeth. Despite this, it remains one of the most effective agents for non-invasive caries management. |
| Intervention |
5% Nano Silver Fluoride (NSF) |
In this study, the intervention involves the application of 5% Nano Silver Fluoride (NSF), which consists of nano-sized silver particles combined with 5% fluoride. The material is applied to the tooth surface using a cotton pellet or micro brush for approximately 10 seconds on a clean air-dried surface. The nano silver particles exert a potent antimicrobial effect against cariogenic bacteria such as Streptococcus mutans, while the fluoride component promotes remineralization of incipient enamel lesions. This combination is designed to arrest the progression of dental caries effectively without causing discoloration of the treated tooth surface, making it a promising minimally invasive approach for managing early carious lesions in children. |
| Comparator Agent |
5% Sodium Fluoride (NaF) Varnish |
The comparator material, 5% Sodium Fluoride (NaF) varnish, is a conventional fluoride formulation widely used in preventive dentistry. It is applied directly onto the tooth surface using a cotton pellet or micro brush for approximately 10 seconds on a clean, dry surface. The varnish acts as a sustained-release source of fluoride, enhancing enamel remineralization and inhibiting demineralization. Through this mechanism, it helps in preventing the initiation and progression of dental caries, making it a standard and well-established agent in caries control protocols for children. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Subject who is willing to participate in the study and has
given written consent.
Children aged 4 to 8 years with incipient lesions or dental
caries in primary teeth
Absence of pulp involvement, pain, mobility, abscess,
sinus, or fistula.
Participants should be free of any systemic diseases. |
|
| ExclusionCriteria |
| Details |
Children whose parents refused to give consent
Primary teeth with irreversible pulpitis
Primary teeth which are close to exfoliation
Children with fluorosis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caries arrest rate measured by change in lesion hardness and color |
Caries arrest rate measured by change in lesion hardness and color at 1 week 3 months
6 months 9months 12months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parental satisfaction and child acceptance of treatment |
Immediately post intervention |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
22/12/2025 |
| 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="0"
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
|
Over the past two decades, dentistry has evolved significantly yet dental caries remains a prevalent chronic disease worldwide particularly among children. Factors such as poor oral hygiene dietary habits limited access to care and socioeconomic conditions contribute to its high occurrence. Many cavities go untreated due to the overwhelming demand for oral healthcare services. Minimally invasive cost-effective approaches are replacing traditional drilling and filling methods to arrest caries progression. A shift toward a medical model of caries management focusing on prevention and remineralization is essential. While fluoride-based treatments are widely used they require patient compliance and multiple applications. To address this, the present study aimed to compare and evaluate the cariostatic efficacy of 5% nanosilver fluoride 38% silver diamine fluoride 5% sodium fluoride varnish on primary teeth in children of age group 4 to 8 years with incipient carious lesions an Invivo randomized clinical study. Ethical clearance was obtained from the institutional review board before conducting the study. A total of 160 incipient lesions of primary teeth were included in the study. Children were randomly assigned to one of four groups Group I 5% nanosilver fluoride, Group II 38% silver diamine fluoride, Group III 5% sodium fluoride varnish and Group IV saline served as the control group. After obtaining the consent form from the parents Under a sterile condition topical fluoride application was done to individuals of respective groups. The evaluation of cariostatic efficacy in terms of depth size and sensitivity was assessed in four groups. The results were subjected to statistical analysis. It was observed that the superior efficacy of SDF and NSF in managing dental caries. While SFV offers temporary benefits its long-term efficacy is limited. Saline proved ineffective confirming the need for active intervention. SDF emerged as the most effective agent, followed closely by NSF making these treatments highly recommended for caries management. |