| CTRI Number |
CTRI/2025/08/093836 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of different anti-oxidants in reducing tooth discoloration caused by silver diamine fluoride in primary molars |
|
Scientific Title of Study
|
Comparative evaluation of the effect of different anti-oxidants in reducing tooth discoloration caused by 38 percent silver diamine fluoride in primary molars- 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 |
Sheel Mate |
| Designation |
Post graduate student |
| Affiliation |
Ranjeet Deshmukh Dental college and research centre |
| Address |
Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and research Centre, Digdoh hills.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
08669937652 |
| Fax |
|
| Email |
shanumate@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gagandeep Lamba |
| Designation |
Associate Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre |
| Address |
Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and Research Centre, Digdoh hills.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
8983184861 |
| Fax |
|
| Email |
drgagandeeplamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gagandeep Lamba |
| Designation |
Associate Professor and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre |
| Address |
Department of Pediatric and Preventive Dentistry, Ranjeet Deshmukh Dental College and research Centre, Digdoh hills.
Nagpur
MAHARASHTRA
440016
India |
| Phone |
8983184861 |
| Fax |
|
| Email |
drgagandeeplamba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre Hingna road, Digdoh hills, Police nagar,Nagpur, Maharashtra, India Pincode-440016 |
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and research Centre |
| Address |
Ranjeet Deshmukh Dental College and research Centre, Digdoh hills, Police nagar, Nagpur |
| 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 |
| Sheel Mate |
Ranjeet DeshmukhDental College andResearch Centre |
Department of Pediatric and Preventive Dentistry.
Nagpur
MAHARASHTRA |
08669937652
shanumate@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RDDCRCIEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
3-8-year-old healthy patient presenting primary molars with occlusal carious lesion having ICDAS score 3,4,5 and radiograph showing presence of sound dentin. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alpha Lipoic acid |
Alpha-lipoic acid (ALA) is a potent antioxidant with the presence of 2 thiol groups. Studies have found that it reduces discoloration caused by 38 percent SDF.Apply the prepared ALA test solutions onto the SDF-treated surface using a clean micro-brush, followed by a gentle clean air spray for 1 minute to aid drying, and then rinse the tooth for 30 seconds. |
| Intervention |
Glutathione |
Glutathione (GSH), a potent antioxidant tripeptide containing a thiol group and one of the most common intracellular non-protein thiols, acts as a reducing agent. When combined with SDF, helps retain silver ions within the solution and on dental surfaces. GSH is mixed with SDF before application on the carious lesion, and the applied SDF + GSH solution is left on the tooth surface for 2 minutes followed by rinsing for 30 seconds.
|
| Comparator Agent |
Potassium Iodide |
Potassium iodide acts as a reducing agent following the application of silver diamine fluoride. It reacts with free silver ions, forming a precipitate of silver iodide, which reduces the staining effect. A saturated KI solution will be immediately applied after SDF application, with repeated applications until the creamy white precipitate turns clear, followed by rinsing the tooth for 30 seconds. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
The study will include healthy children aged 3 to 8 years with a Frankl behavior rating of 3 or 4. Selected teeth were primary molars presenting with occlusal carious lesions having an ICDAS score of 3, 4, or 5, with radiographic evidence of sound dentin. Written informed consent was obtained from the parent prior to participation.
|
|
| ExclusionCriteria |
| Details |
The exclusion criteria will comprise medically compromised patients, those with thyroid gland disorders, individuals with a known history of allergy to silver, and highly uncooperative patients.
|
|
|
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 |
To evaluate and compare the effectiveness of anti-oxidants ALA and GSH with KI in reducing
discoloration caused by 38% SDF in carious primary molars. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess if the reduction in discoloration is acceptable by parents. |
1 week |
| To evaluate the palatability of ALA, GSH & KI after application of 38 percent SDF. |
1 week |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 3 |
|
Date of First Enrollment (India)
|
18/09/2025 |
| 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="1"
Months="4"
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
|
A randomised controlled trial to evaluate and compare the effectiveness of antioxidants Alpha Lipoic Acid and Glutathione with Potassium Iodide in reducing discoloration caused by 38 percent Silver Diamine Fluoride in carious primary molars. |