| CTRI Number |
CTRI/2024/08/072304 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare 4 separate caries arresting agents by means of a randomized clinical trial |
|
Scientific Title of Study
|
Comparing the efficacy of four different types of agents for arresting caries in primary teeth -A randomized controlled double blind 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 |
Sharmistha Dewakar Goel |
| Designation |
Research Scholar |
| Affiliation |
Manav Rachna Dental college |
| Address |
Department of Public health dentistry Room- QG 31,Q block Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004
Faridabad
HARYANA
121001
India |
| Phone |
09953504536 |
| Fax |
|
| Email |
sharmistha.goel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnmol Mathur |
| Designation |
Head of the Department |
| Affiliation |
Manav Rachna Dental college |
| Address |
Department of Public health dentistry Room- QG 31,Q block Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004
Faridabad
HARYANA
121001
India |
| Phone |
09953504536 |
| Fax |
|
| Email |
anmolmathur.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anmol Mathur |
| Designation |
Head of the department |
| Affiliation |
Manav Rachna Dental college |
| Address |
Department of Public health dentistry Room- QG 31,Q block Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004
Faridabad
HARYANA
121001
India |
| Phone |
09953504536 |
| Fax |
|
| Email |
anmolmathur.sds@mrei.ac.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna Dental college
Sector – 43,Delhi- Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 |
|
|
Primary Sponsor
|
| Name |
Manav Rachna Dental College and Hospital |
| Address |
Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSharmistha Dewakar Goel |
Manav Rachna Dental College |
Department of Public Health Dentistry Room- QG 31,Q block Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004
Faridabad
HARYANA |
09953504536
sharmistha.sds@mrei.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Manav Rachna International insitute of reasearch and studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
38% Silver diamine fluoride varnish, caries arresting agent. |
Teeth will be isolated using cotton roll/gauze
The varnish will be applied in sweeping horizontal brush stokes across the teeth
|
| Intervention |
38% Silver fluoride with potassium iodide, caries arresting agent. |
Teeth will be isolated with cotton rolls and the solution containing silver fluoride is applied with the help of an applicator tip.Following this application a solution of potassium iodide is applied
to the area(s) until the creamy white turns clear.
Blot dry with cotton pellet |
| Intervention |
5% Nano silver fluoride, caries arresting agent. |
The tooth is isolated with cotton rolls and the solution is applied on the carious tooth surfaces with a micro brush and rubbed for 10 seconds.After 2 minutes the cotton roll is removed |
| Comparator Agent |
5% Sodium fluoride varnish, caries arresting agent. |
Applying Caries arresting agent- 5% Sodium fluoride varnish.
Tooth surfaces will be cleaned by use of cotton rolls and gauze.
Teeth will be isolated using cotton roll/gauze
The varnish will be applied in sweeping horizontal brush stokes across the teeth
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative healthy child
Children- age of 4 to 9 years with an active carious lesion.
Children studying in a school in Faridabad.
Absence of pain, pulp involvement, tooth mobility.
Children who assent to the procedure and have obtained a written informed consent from their parents/guardians.
|
|
| ExclusionCriteria |
| Details |
Criteria for exclusion:
Children whose parents have refused to give a written informed consent to be a part of the study.
Carious tooth close to exfoliation within 18 months
Even if there is a slight mobility noticed in the tooth it will not be included in the study.
Children with a known allergy to silver or other heavy metal ions
Children with special needs or limited dexterity of hands
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Caries arrest or progression |
3,6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Re-initiation of carious lesion |
12 months |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
19/08/2024 |
| 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)
Modification(s)
|
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
|
Dental caries a widespread global disease having a very high prevalence and it requires treatment to stop its progression. Children in developing countries are highly vulnerable and have high rates of untreated caries. Due to the extensive equipment required for its treatment it limits its reach to people and requires on site intervention. The abstract provides a concise overview of comparing the efficacy of four different caries arresting agents that will be compared by means of a community based, randomized clinical trial in primary teeth. A total of 240 children with an active carious lesion would be selected and randomly divided into one of the four groups-silver diamine fluoride varnish, Nano silver fluoride, sodium fluoride varnish and a solution of silver fluoride in water with Potassium iodide. The child and parental satisfaction level would be assessed by means of self-reports at 6 months. After the application of the caries arresting agent according to given guidelines follow up will be done at 3,6 and 12 months to check if the carious lesion is active. Through a comprehensive analysis this study aims to find which carries arresting agent demonstrates the most superior efficacy to arrest a carious lesion in a community setting. Keywords-Caries arrest, SDF, Primary teeth, caries arresting agents, community based, randomized control trial. |