| CTRI Number |
CTRI/2025/05/087023 [Registered on: 15/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Compare the Effect of Silver Fluoride Treatment With and Without Light on Tooth Decay in Children’s Milk Teeth |
|
Scientific Title of Study
|
Comparative evaluation of silver diamine fluoride (sdf) with and without light curing for managing moderate carious lesions in primary teeth : a randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahina khanam |
| Designation |
junior resident- 1 |
| Affiliation |
Faculty of dental science,KGMU lucknow |
| Address |
New building,faculty of dental science,4th floor,Room no -4,PG Clinic,KGMU lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
08084164138 |
| Fax |
|
| Email |
shahinakhanam.sk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa khanna |
| Designation |
Professor |
| Affiliation |
Faculty of dental science,KGMU lucknow |
| Address |
New building,faculty of dental science,4th floor,Room no -4,PG Clinic,KGMU lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9936038511 |
| Fax |
|
| Email |
richa.bahal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa khanna |
| Designation |
Professor |
| Affiliation |
Faculty of dental science,KGMU lucknow |
| Address |
New building,faculty of dental science,4th floor,Room no -4,PG Clinic,KGMU lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9936038511 |
| Fax |
|
| Email |
richa.bahal@gmail.com |
|
|
Source of Monetary or Material Support
|
| New building,faculty of dental science,4th floor,Room no -4,PG Clinic,KGMU lucknow 226003 |
|
|
Primary Sponsor
|
| Name |
Shahina khanam |
| Address |
New building,faculty of dental science,4th floor,Room no -4,PG Clinic,KGMU lucknow 226003 |
| 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 Shahina Khanam |
King George Medical University,Lucknow |
PG clinic ,Room no-4,4th floor,Department of Paediatric and Preventive Dentistry.
Lucknow
UTTAR PRADESH |
08084164138
shahinakhanam.sk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King George Medical University UP Institutional Ethics Committee Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participants must have moderate carious lesions on buccal surfaces of primary teeth (ICDAS criteria) and be classified as having a moderate to high risk of caries development (ICCMS™ protocol). |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Silver Diamine Flouride |
Application of Silver Diamine Fluoride (SDF) directly to the carious lesions without light curing. |
| Intervention |
Silver Diamine Fluoride with Light curing |
Application of Silver Diamine Fluoride (SDF) directly to the carious lesions.Immediate exposure to light-curing with a dental curing light for 20-30 seconds per lesion. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with moderate/high caries likelihood as classified under ICCMS™ protocol. (International Caries Classification and Management System).
2.Patients presenting with ‘moderate stage carious’ lesions (as per ICDAS merged categories) International Caries Detection and Assessment System on buccal/facial primary tooth surfaces in either maxillary or mandibular arch.
3.Uncooperative children with’ definitely negative’ or ‘negative’ behavioural rating according to Frankl behavioural rating scale. .
4.Patients whose parents give consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Patient presenting with only ‘initial/extensive stage carious’ lesions (as per ICDAS merged categories).
2.Patient with any metabolic disorder, medically compromised conditions.
3.Patient with tooth developmental defects/anamolies.
4.Patient with previous history of non-invasive/microinvasive caries management interventions.
5.Patients whose parents did not agree to participate in the study.
6.Patients with history of xerostomia or any condition that reduces salivary flow.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To compare the effectiveness of Silver Diamine Fluoride (SDF) with and without light curing in controlling staging of moderate carious lesions limited to dentin in primary teeth as determined by clinical and radiographic examination. |
Clinical evaluation: T0 (baseline), T1 (three months post intervention), T2 (six months post intervention) and T3 (nine months post intervention), T4 (twelvemonths post intervention).
Radiographic evaluation: T0 (baseline), T2 (six months post intervention), and T3 (nine months post intervention), T4 (twelve months post intervention).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Change in activity status of carious lesions from baseline
-Parental satisfaction during treatment
-Patient-Reported pain and discomfort during treatment
|
baseline,3 months,6 months,9 months,12 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
02/08/2025 |
| 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="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
|
Introduction Dental caries is a prevalent infectious disease that leads to tooth structure disintegration. Traditional treatments such as restorative procedures and extractions can be traumatic, especially for children. Silver diamine fluoride (SDF) has gained attention as a minimally invasive option for caries prevention and arrest. The study aims to assess the impact of light curing on SDF efficacy in controlling moderate carious lesions in primary teeth. Objective The primary objective is to compare the effectiveness of SDF with and without light curing in arresting moderate carious lesions in primary teeth using clinical and radiographic evaluations. Secondary objectives include evaluating caries activity, parental satisfaction, and patient-reported pain and discomfort between the two techniques. Methodology A randomized controlled study will be conducted at the Department of Pediatric and Preventive Dentistry, King George’s Medical University. Pediatric patients aged 2-5 years with moderate-stage carious lesions will be randomly assigned to two groups: - Group A (Intervention): SDF application followed by immediate light curing for 20-30 seconds.
- Group B (Control): SDF application without light curing.
Caries progression and activity will be assessed using clinical and radiographic examinations over 12 months. Parental satisfaction and patient discomfort will be evaluated using Likert and Visual Analogue Scales. Statistical analysis will be performed to determine the significance of differences between the groups. Expected Outcome It is anticipated that light curing will enhance the efficacy of SDF in controlling carious lesions by improving silver ion penetration, increasing dentin hardness, and potentially reducing lesion progression compared to SDF application alone. Conclusion The study aims to provide clinical insights into optimizing SDF application for pediatric patients. Findings may contribute to the development of a more effective, patientfriendly caries management protocol, particularly for young children and those with limited access to dental care. |