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

Sponsor

Postgraduate Institute of Dental Sciences Rohtak (Other)

Overall Status

Completed

CT.gov ID

NCT05791669

Collaborator

(none)

Enrollment

Location

Arms

15.2

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Caries Arrested	Drug: Silver diamine fluoride Drug: Sodium fluoride varnish	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Aug 2, 2022

Actual Study Completion Date :

Nov 8, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 38% silver diamine fluoride	Drug: Silver diamine fluoride 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. Other Names: FAgamin SDF38%
Active Comparator: 5% sodium fluoride varnish	Drug: Sodium fluoride varnish 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. Other Names: VOCO profluorid varnish

Arm

Intervention/Treatment

Experimental: 38% silver diamine fluoride

Drug: Silver diamine fluoride

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.

Other Names:

FAgamin SDF38%

Active Comparator: 5% sodium fluoride varnish

Drug: Sodium fluoride varnish

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.

Other Names:

VOCO profluorid varnish

Outcome Measures

Primary Outcome Measures

Caries arrest [12 months]
Assessment with bitewing radiographs based on ICCMS radiographic scoring system

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 9 Years

Sexes Eligible for Study:

All

Accepts 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:

Presence of advanced carious lesions reaching inner third of dentin detected by bitewing radiographic examinations ICCMSTM (RC5, RC6).
Children or adolescents that refuse to participate in the study or present negative behaviours.
Teeth with premature hypermobility 5. Both physically and mentally disabled children