| CTRI Number |
CTRI/2025/06/088042 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A comparative study on silver ion penetration in three different application techniques under scanning electron microscopy |
|
Scientific Title of Study
|
Comparative evalutaion of silver diamine fluoride penetration into dentine with three different application techniques using scanning electron microscope- energy dispersive x-ray spectroscopy an ex-vivo 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 |
Dr Julita Joseph |
| Designation |
postgraduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
The Oxford Dental College,
Bangalore
The Oxford Dental college
Bangalore
KARNATAKA
560068
India |
| Phone |
9990565773 |
| Fax |
|
| Email |
julitajoseph23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharath Vardhana |
| Designation |
Reader |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
The Oxford Dental College,
Bangalore
The Oxford Dental college
Bangalore
KARNATAKA
560068
India |
| Phone |
9886588595 |
| Fax |
|
| Email |
bharath.dentist@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Julita Joseph |
| Designation |
postgraduate |
| Affiliation |
The Oxford Dental College |
| Address |
Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
The Oxford Dental College,
Bangalore
The Oxford Dental college
Bangalore
KARNATAKA
560068
India |
| Phone |
9990565773 |
| Fax |
|
| Email |
julitajoseph23@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Oxford Dental College
Bommanahalli, Hosur Road,
Bangalore- 560068
India |
|
|
Primary Sponsor
|
| Name |
Dr Julita Joseph |
| Address |
The Oxford Dental College,
Bommanahalli, Hosur road
Bangalore- 560068
Karnataka |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bharath Vardhana |
The Oxford Dental College,
Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Julita Joseph |
The oxford Dental College |
Department of Pediatric and Preventive Dentistry,
4th floor, room no. 8
The Oxford Dental College,
Bangalore
The Oxford Dental college
Bangalore
KARNATAKA |
09990565773
julitajoseph23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Oxford Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
silver diamine fluoride |
comparative evalutaion of silver diamine fluoride penetration into dentine with three different application techniques using scanning electron microscope- energy dispersive x-ray spectroscopy |
| Comparator Agent |
silver diamine fluoride |
three comparative group to check the penetration of silver ion using silver diamine for 1 minute on the carious tooth as control group and silver diamine fluoride for 1 minute followed by with potassium iodide for 2 minute on the carious tooth and silver diamine fluoride with curing light for 20 seconds on carious tooth as experimental group |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Freshly extracted carious primary teeth that are nearing exfoliation.
Primary teeth with visible dentinal caries.
|
|
| ExclusionCriteria |
| Details |
Primary teeth with caries involving pulp.
Primary teeth previously treated with SDF(silver diamine fluoride).
Primary teeth with restorations.
Primary teeth with developmental anomalies.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SDF increases the resistance to acid dissolution and increases mineral density and hardness. A rich mineralised layer can be found on the surface of arrested carious lesions.Applying KI with SDF creates a silver iodide precipitate that is yellow, insoluble and does not cause black staining on the tooth |
Silver penetration at 1min, after 2min and after 20seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficiency of SDF when applied alone and when applied with potassium iodide and light curing. |
Efficiency of SDF when applied alone and when applied with potassium iodide and light curing. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This is a comparative study done to evaluate the amount of silver ions in carious lesions in tooth treated with silver diamine fluoride, silver diamine fluoride followed by potassium iodide and silver diamine fluoride with light curing for 20 seconds. SDF increases the resistance to acid dissolution and
increases mineral density and hardness. A rich mineralised layer can be found
on the surface of arrested carious lesions. It also exhibits control
of caries infection, simplicity of use, affordability, minimal requirement for
training and it is a minimally invasive treatment. Potassium iodide
(KI) is a salt that generates white or transparent hexahedral crystals.
Applying KI with SDF creates a silver iodide precipitate that is yellow,
insoluble and does not cause black staining on the tooth.
It is seen that curing
of SDF using light emitting diode (LED) light curing increased precipitation of
silver ions in the infected dentine layer of the carious lesion. |