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

Phase 2

Completed

• Conditions: Child Discomfort; Dental Caries
• Interventions: Drug: ART; Drug: SDF

• Registration Number: NCT04654624
• Lead Sponsor: Nourhan M.Aly

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-10-12
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-30
• Status Verified: 2020-11
• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Last Update Submitted: 2020-11-27
• Study First Posted: 2020-12-04
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atraumatic Restorative Treatment	ART	-
Silver Diamine Fluoride	SDF	-

Primary Outcome Measures

Name	Time	Method
Pain perception	6 months	Pain reaction was assessed using the Sound, Eye, Motor scale (SEM) according to Wright et al. criteria. It is an objective method for pain assessment, where the child's level of anxiety was evaluated according to three types of observations. The score in each category ranged from one (no pain) to four (intense pain). A lower score represents less physical reaction to the procedure than does a higher value. Time of treatment was recorded using a stopwatch.

Secondary Outcome Measures

Name	Time	Method
Parents' acceptability of the treatment modality	2 weeks	It was assessed using a 5-likert scale, self-administered questionnaire, specifically designed for the current study.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt