Atraumatic Restorative Treatment Sealants in First Permanent Molars

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

437 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Caries, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Split-mouth design

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Glass ionomer sealant

Two hand-mixed glass ionomer cements (GICs) available in the dental market were used, and they were mixed according to the manufacturer's instructions (powder/liquid ratio 1:1). The molars were cleaned with a toothbrush and wet cotton wool pellets. Isolation was performed with cotton wool rolls and the occlusal surface was conditioned with GIC liquid (20s), rinsed with wet cotton wool pellets and dried with dry cotton wool pellets. GIC was placed on the occlusal surface and pressed into the pits and fissures using the press-finger technique. The excess of material was removed and the occlusion checked and adjusted. Sealant was protected with a new layer of petroleum jelly and the children were instructed not to eat for at least one hour. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months.

Group Type EXPERIMENTAL

Glass ionomer sealant

Intervention Type PROCEDURE

Non-sealant (toothbrushing)

No sealant was performed. Children received instructions on how to brush their teeth (1,000-ppm fluoridated dentifrice), as well as advices regarding diet and information about dental caries was given by a dental assistant and those instructions were repeated every 6 months.

Group Type OTHER

Non-sealant (toothbrushing)

Intervention Type BEHAVIORAL

Interventions

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Glass ionomer sealant

Intervention Type PROCEDURE

Non-sealant (toothbrushing)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients presenting the four first permanent molars without gingival tissue covering the occlusal surface and without clinically detectable dentine caries lesion, assessed as scores 0, 1 and 2 of ICDAS criteria \[Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 \].