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Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution

Primary Purpose

Caries Arrested

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Silver diamine fluoride
Sodium fluoride varnish
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caries Arrested focused on measuring Caries arrest ,interproximal caries, primary molars, SDF

Eligibility Criteria

5 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children aged 5 to 9 years. Presence of at least 2 primary molars with interproximal caries. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4). Exclusion Criteria: 1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6). 3. Children or adolescents that refuse to participate in the study or present negative behaviours. 4. Teeth with premature hypermobility 5. Both physically and mentally disabled children

Sites / Locations

  • Post graduate institute of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

38% silver diamine fluoride

5% sodium fluoride varnish

Arm Description

Outcomes

Primary Outcome Measures

Caries arrest
Assessment with bitewing radiographs based on ICCMS radiographic scoring system

Secondary Outcome Measures

Full Information

First Posted
November 12, 2022
Last Updated
March 17, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05791669
Brief Title
Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution
Official Title
Arrest of Interproximal Caries Lesion in Primary Molars With 38% Silver Diamine Fluoride Solution and 5% Sodium Fluoride Varnish: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 2, 2022 (Actual)
Study Completion Date
November 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was conducted to assess the efficacy of 38% Silver Diamine fluoride and compare it with 5% sodium fluoride varnish in arresting interproximal caries in primary molars at 12 months follow-up. Bitewing radiographs were taken to diagnose as well as to assess caries depth at follow up visits. Each bitewing was scored based on ICCMS radiographic criteria and was compared (follow-ups to baseline)to check for caries arrest. Interproximal caries included in this study, according to ICCMS criteria, were at stages- RA - caries limited to outer half of enamel RA2 - caries limited to the inner half of enamel RA3 - caries limited to outer third of dentine RA4 - caries limited to middle third of dentine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries Arrested
Keywords
Caries arrest ,interproximal caries, primary molars, SDF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
38% silver diamine fluoride
Arm Type
Experimental
Arm Title
5% sodium fluoride varnish
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Silver diamine fluoride
Other Intervention Name(s)
FAgamin SDF38%
Intervention Description
Silver diamine fluoride is a topical medication composed of 25% silver, 5% fluoride, 8% ammonia, and 62% Deionized water, used to treat and prevent dental caries and relieve dentinal hypersensitivity.
Intervention Type
Drug
Intervention Name(s)
Sodium fluoride varnish
Other Intervention Name(s)
VOCO profluorid varnish
Intervention Description
It is a topical application with an active ingredient of 5% sodium fluoride(22,600ppm fluoride).it prolongs the contact time between the fluoride and tooth surface and promotes remineralization and inhibits demineralization.
Primary Outcome Measure Information:
Title
Caries arrest
Description
Assessment with bitewing radiographs based on ICCMS radiographic scoring system
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged 5 to 9 years. Presence of at least 2 primary molars with interproximal caries. Carious lesions of enamel or outer or middle third of dentin in primary molars, as assessed by bitewing radiographs with ICCMSTM scoring (RA1, RA2, RA3, RB4). Exclusion Criteria: 1. Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6). 3. Children or adolescents that refuse to participate in the study or present negative behaviours. 4. Teeth with premature hypermobility 5. Both physically and mentally disabled children
Facility Information:
Facility Name
Post graduate institute of dental sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

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Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution

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