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

Postgraduate Institute of Dental Sciences Rohtak

Status and phase: Completed; Phase 3

Conditions: Caries Arrested

Treatments: Drug: Silver diamine fluoride; Drug: Sodium fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT05791669

PGIDS/BHRC/21/13

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 5 to 9 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups

38% silver diamine fluoride

Experimental group

Treatment:

Drug: Silver diamine fluoride

5% sodium fluoride varnish

Active Comparator group

Treatment:

Drug: Sodium fluoride varnish