Stopping Cavities Study: Diammine Silver Fluoride

Advantage Dental Services

Status and phase: Completed; Phase 3

Conditions: Dental Caries

Treatments: Drug: 38% diammine silver fluoride; Other: Water

Study type: Interventional

Funder types: Industry

Identifiers

NCT02536040

003

Details and patient eligibility

About

This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

Full description

Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.

Enrollment: 66 patients

Sex: All

Ages: 24 to 60 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nyvad criteria 3
• Active carious lesion

Exclusion criteria

• Allergy to silver
• Stomatitis or oral ulcerative condition
• Weight less than 15 kg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 2 patient groups, including a placebo group

38% diamine silver fluoride

Experimental group

Description:

Topical application of 38% diammine silver fluoride to active cavity

Treatment:

Drug: 38% diammine silver fluoride

Water

Placebo Comparator group

Description:

Topical application of fluoride free water to active cavity

Treatment:

Other: Water