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Outcomes of Restoring Untreated and SDF-treated Dentine Caries Lesions in Primary Teeth of Preschool Children

NCT03657862 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2018-09-05

No results posted yet for this study

Summary

The primary objective of this proposed clinical study is to compare the success rates of ART restorations placed in untreated and SDF-treated dentine caries lesions in primary teeth. The secondary objective is to describe the change in parents' satisfaction with the aesthetics of their child's teeth and the change in oral health-related quality of life of preschool children before and after placement of ART restorations.

The study population is preschool children attending kindergartens in different districts in Hong Kong. Children attending grades 1 or 2 in nine kindergartens were invited to receive a free dental examination and had their decayed primary teeth restored, if possible, in the kindergarten by dentists. Parental informed consent was obtained before the dental examination and treatment. Half of the children with decayed primary teeth needing restorations were assigned randomly to receive SDF treatment around 10 weeks before receiving the restoration. The restored teeth were re-examined every 6 months for 24 months to assess the treatment outcome. Parents of the study children were asked to complete a questionnaire at baseline, 6 months and 24 months so as to obtain data on their satisfaction with the aesthetics of their child's teeth and the oral health-related quality of life of the study children.

Conditions

  • Dental Restoration Failure of Marginal Integrity

Interventions

DEVICE

application of 38% silver diamine fluoride solution

SDF solution was painted onto the surface of the carious lesion of the tooth

OTHER

application of a placebo (tonic water)

tonic water was painted onto the surface of the carious lesion of the tooth

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03657862 on ClinicalTrials.gov