Trials / Completed
CompletedNCT03667768
Atraumatic Restorative Treatment Sealants in First Permanent Molars
Atraumatic Restorative Treatment Sealants in First Permanent Molars: a Bi-center Split-mouth Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 437 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 6 Years – 8 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Glass ionomer sealant | |
| BEHAVIORAL | Non-sealant (toothbrushing) |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-01
- First posted
- 2018-09-12
- Last updated
- 2018-11-09
Source: ClinicalTrials.gov record NCT03667768. Inclusion in this directory is not an endorsement.