Silver Diamine Fluoride Gel: Case Series

Completed

• Conditions: Dental Caries in Children
• Interventions: Device: Silver Diamine Fluoride/Sodium Fluoride Varnish

• Registration Number: NCT05395065
• Lead Sponsor: Advantage Silver Dental Arrest, LLC

Brief Summary

A clinical case series to determine the clinical response of dental caries lesions in primary teeth where 38% silver diamine fluoride gel is applied and cover with 2.5% sodium fluoride varnish. Additionally, to assess parent satisfaction with treatment with 38% silver diamine fluoride.

Detailed Description

A clinical case series of 235 children ages 3 and 4 with severe early childhood caries where the lesions are treated with 38% silver diamine fluoride and covered with 2.5% sodium fluoride varnish at baseline and 6 months. The primary objective is to determine the response of dental caries lesions (caries arrest) into the dentin in primary teeth at one year of follow-up. The secondary objective is to assess parent satisfaction with treatment with 38% silver diamine fluoride and 2.5% sodium fluoride varnish.

Study Timeline

• Study First Submitted: 2022-05-24
• Study First Submitted QC: 2022-05-24
• Study First Posted: 2022-05-27
• Study Start: 2022-07-11
• Primary Completion: 2023-07-17
• Status Verified: 2024-01
• Study Completion: 2024-01-29
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

Inclusion Criteria

• At least one active caries lesion Good general health by parent report

Exclusion Criteria

• Unable to cooperate with exam or procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SDF/FV	Silver Diamine Fluoride/Sodium Fluoride Varnish	Topical Application of 38% silver diamine fluoride and 2.5% sodium fluoride varnish at baseline and 6 months

Primary Outcome Measures

Name	Time	Method
Lesion Activity	12 months	Caries Lesion Arrest

Secondary Outcome Measures

Name	Time	Method
Caries Increment	12 months	Caries Increment (d2-4mfs)
New Caries Lesions	12 months	Rate of New Caries Lesions ((d2-4mfs)
Satisfaction with Color Changes in Teeth	5 months	Bothered by Color Changes in the teeth (1-10 scale)

Trial Locations

Locations (5)

UGEL Manazo; 🇵🇪 Puno, Peru

UGEL Puno 210001 Las Torres; 🇵🇪 Puno, Peru

UGEL Puno Magisterial; 🇵🇪 Puno, Peru

UGEL San Jose; 🇵🇪 Puno, Peru

UGEL Villa del Lago; 🇵🇪 Puno, Peru