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

Phase 3

Completed

• Conditions: Caries Arrested
• Interventions: Drug: Silver diamine fluoride; Drug: Sodium fluoride varnish

• Registration Number: NCT05791669
• Lead Sponsor: Postgraduate Institute of Dental Sciences Rohtak

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Primary Completion: 2022-08-02
• Status Verified: 2022-11
• Study Completion: 2022-11-08
• Study First Submitted: 2022-11-12
• Study First Submitted QC: 2023-03-17
• Last Update Submitted: 2023-03-17
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Children aged 5 to 9 years.
2. Presence of at least 2 primary molars with interproximal caries.
3. 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).

2. Children or adolescents that refuse to participate in the study or present negative behaviours.

3. Teeth with premature hypermobility 5. Both physically and mentally disabled children

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
38% silver diamine fluoride	Silver diamine fluoride	-
5% sodium fluoride varnish	Sodium fluoride varnish	-

Primary Outcome Measures

Name	Time	Method
Caries arrest	12 months	Assessment with bitewing radiographs based on ICCMS radiographic scoring system

Trial Locations

Locations (1)

Post graduate institute of dental sciences; 🇮🇳 Rohtak, Haryana, India