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Atraumatic Restorative Treatment Sealants in First Permanent Molars

NCT03667768 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2018-11-09

No results posted yet for this study

Summary

The aim of this bi-center study was to evaluate the retention and caries-preventive effect of Atraumatioc Restorative Treatment (ART) sealants, using two glass ionomer cement (GIC) versus non-sealant on first permanent molars of schoolchildren. The null hypothesis is that there is no difference in the retention rates of the two GIC, as well as in caries prevention between sealants application and non-sealant. Four hundred and thirty-seven 6-to-8-year-old schoolchildren were selected in two cities in Brazil. They were randomly divided into two groups, according to the GIC used (Fuji IX or Maxxion). All children had their four first permanent molars included in the research and two molars were sealed with a GIC, while the other two molars remained unsealed. Clinical evaluations were performed up to 36 months by one independent examiner at each city.

Conditions

  • Caries, Dental

Interventions

PROCEDURE

Glass ionomer sealant

BEHAVIORAL

Non-sealant (toothbrushing)

Sponsors & Collaborators

  • Academic Centre for Dentistry in Amsterdam

    collaborator OTHER

  • Universidade Federal de Pernambuco

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2013-06-30
Completion
2013-06-30

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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 NCT03667768 on ClinicalTrials.gov