Child Discomfort and Parental Acceptability of Silver Diamine Fluoride and Alternative Restorative Treatment

Nourhan M.Aly

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dental Caries; Child Discomfort

Treatments: Drug: SDF; Drug: ART

Study type: Interventional

Funder types: Other

Identifiers

NCT04654624

SDF vs. ART

Details and patient eligibility

About

The aim of the current study was to compare pain perception of young children treated with SDF and ART, as well as their parents' acceptability of both modalities.

Full description

Eighty, 3-8-years-old children, having at least one deciduous asymptomatic tooth with active caries were randomly assigned into 2 groups; SDF for caries arresting in the test group, and ART for caries removal in the control group.

Enrollment: 80 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Negative and definitely negative behavior according to Frankl's behavior rating scale.
• Having at least one deciduous asymptomatic tooth with active caries, as defined by the International Caries Detection and Assessment System; ICDAS II scores 4, 5, 6.

Exclusion criteria

• Children who suffered from silver allergy, oral ulcerations, pulpal infections and whose parents needed immediate permanent restorations.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Silver Diamine Fluoride

Experimental group

Treatment:

Drug: SDF

Atraumatic Restorative Treatment

Active Comparator group

Treatment:

Drug: ART