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

NCT05791669 | Completed Phase 3 DMC

• 1 other identifier: PGIDS/BHRC/21/13
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Caries Arrested

Keywords

Caries arrest ,interproximal caries, primary molars, SDF

Outcome Measures

Primary Outcomes (1)

• Caries arrest

  Assessment with bitewing radiographs based on ICCMS radiographic scoring system

  12 months

Study Arms (2)

38% silver diamine fluoride

EXPERIMENTAL

Drug: Silver diamine fluoride

5% sodium fluoride varnish

ACTIVE COMPARATOR

Drug: Sodium fluoride varnish

Interventions

Silver diamine fluoride DRUG

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.

Also known as: FAgamin SDF38%

38% silver diamine fluoride

Sodium fluoride varnish DRUG

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.

Also known as: VOCO profluorid varnish

5% sodium fluoride varnish

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post graduate institute of dental sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

silver diamine fluoride; Bifluorid 12

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2022
• First Posted: March 30, 2023
• Study Start: August 1, 2021
• Primary Completion: August 2, 2022
• Study Completion: November 8, 2022
• Last Updated: March 30, 2023

Record last verified: 2022-11

Locations

IN (1)