Atraumatic Restorative Treatment Sealants in First Permanent Molars

University of Sao Paulo

Status: Completed

Conditions: Caries, Dental

Treatments: Behavioral: Non-sealant (toothbrushing); Procedure: Glass ionomer sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT03667768

USP-SaoPaulo

Details and patient eligibility

About

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.

Enrollment: 437 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts Healthy Volunteers

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 ].

Exclusion criteria

• patients presenting any physical and/or medical health issues and having non-cooperative behavior.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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437 participants in 2 patient groups

Glass ionomer sealant

Experimental group

Description:

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.

Treatment:

Procedure: Glass ionomer sealant

Non-sealant (toothbrushing)

Other group

Description:

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.

Treatment:

Behavioral: Non-sealant (toothbrushing)