| CTRI Number |
CTRI/2025/07/091078 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of light cured silver diamine fluoride and SDF-KI on arresting caries |
|
Scientific Title of Study
|
Comparison of light cured silver diamine fluoride with Silver Diamine Fluoride- Potassium iodide on arresting carious lesions in primary teeth: A randomized 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 |
Chithaluru Pranathi |
| Designation |
Post Graduate Student |
| Affiliation |
University College of medical Sciences Delhi |
| Address |
Department of dentistry unit of pedodontics UCMS GTBH
North East
DELHI
110095
India |
| Phone |
6380508241 |
| Fax |
|
| Email |
pranathichithaluru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rishi Tyagi |
| Designation |
Professor and Head |
| Affiliation |
University College of medical Sciences Delhi |
| Address |
Department of dentistry unit of pedodontics UCMS GTBH
North East
DELHI
110095
India |
| Phone |
9868575552 |
| Fax |
|
| Email |
tyagi_rishidoc@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Chithaluru Pranathi |
| Designation |
Post Graduate Student |
| Affiliation |
University College of medical Sciences Delhi |
| Address |
Department of dentistry unit of pedodontics UCMS GTBH
North East
DELHI
110095
India |
| Phone |
6380508241 |
| Fax |
|
| Email |
pranathichithaluru@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Chithaluru Pranathi |
| Address |
Room no 250,Department of dentistry Unit of Paedodontics Ucms and GTBH, Delhi 110095 |
| 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 Chithaluru Pranathi |
Room no 252 Department of dentistry Unit of Pedodontics UCMS and GTBH |
UCMS and GTBH Dilshad Garden 110095
North East
DELHI |
6380508241
pranathichithaluru@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE-HUMAN RESEARCH, UNIVERSITY COLLEGE OF MEDICAL SCIENCES, UNIVERSITY OF DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Light cured Silver diamine Fluoride |
Light curing of silver diamine fluoride where curing light is used after silver diamine fluoride application for enhancing its properties. |
| Comparator Agent |
Silver diamine fluoride- Potassium iodide |
A liquid solution containing silver fluoride and ammonia used topically in dental caries arrest. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
1. Systemically healthy and cooperative children.
2. Children of age group 4-7 years with atleast one active carious lesion bilaterally in a primary mandibular molar with score 4 or 5 (asymptomatic dentinal caries) according to the International Caries Detection And Assessment System- ICDAS II detected using visual and tactile inspection to assess lesion severity and activity and RA 3 according to ICCMS TM.
3. Teeth with no signs of pulpal involvement.
4. Teeth with no signs of pain, abscess, fistula.
5. Teeth with no premature hypermobility.
6. Teeth with no internal or external root resorption.
7. Children whose parents are willing to give consent.
8. Teeth with atleast two third of the root length remaining. |
|
| ExclusionCriteria |
| Details |
1. Teeth that caused spontaneous pain or showed signs of pulpal infection, swelling and or/abscess.
2. Children with history of major systemic disorders.
3. Children with allergy to silver or any materials used in the study.
4. Children with intellectual disability.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate caries arrest rate, clinical success, radiographic success and parental acceptance of
a.Light cured silver diamine fluoride
b.Silver diamine fluoride with potassium iodide . |
Follow up at 3 months, 6 months and 9 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the parental satisfaction of sdf and light cured sdf |
9 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
09/09/2025 |
| 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="0"
Months="9"
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
|
Patients will be recruited from the outpatient settings of Department of Dentistry (Unit of Pediatric and Preventive Dentistry), University college of Medical Sciences and GTB Hospital. All healthy children having carious primary molars in mandibular arch, indicated for restoration satisfying inclusion and exclusion criteria will be included in the study . Caries arrest rate will be recorded over a period of 3 months, 6 months and 9 months. Clinical success will be recorded at 3 months, 6 months and 9 months. Radiographic success will be recorded at 3 months, 6 months and 9 months. Parental acceptance for ease of application, discolouration, pain related to application and discomfort in taste will be recorded using 5 point Likert Scale with scoring being strongly agree, agree, neutral, disagree, strongly disagree will be recorded post treatment and after 3 months. |