Atraumatic Restorative Treatment Sealants in First Permanent Molars

NCT03667768 | Completed

• 1 other identifier: USP-SaoPaulo
• Study Type: interventional
• Target: 437
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Dentition, Permanent; Glass Ionomer Cements

Outcome Measures

Primary Outcomes (1)

• Changes in glass ionomer selants retention

  The sealants retention was evaluated clinically using the criteria: 0) fully present sealant; 1) partially present sealant and 2) absent sealant \[Oba AA, Dülgergil T, Sönmez IŞ, Doǧan S (2009) Comparison of Caries Prevention With Glass Ionomer and Composite Resin Fissure Sealants. J Formos Med Assoc 108:844-848\]. Scores 0 and 1 were considered "success," whereas score 2 was considered "failure."

  3, 6, 12, 18, 24 and 36 months

Secondary Outcomes (2)

• Changes in caries status of first permanent molars

  3, 6, 12, 18, 24 and 36 months

• Comparison between the development of caries in dentine(measured using ICDAS score system) of first permanent molars between the two cities

  3, 6, 12, 18, 24 months

Study Arms (2)

Glass ionomer sealant

EXPERIMENTAL

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.

Procedure: Glass ionomer sealant

Non-sealant (toothbrushing)

OTHER

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.

Behavioral: Non-sealant (toothbrushing)

Interventions

Glass ionomer sealant PROCEDURE

Glass ionomer sealant

Non-sealant (toothbrushing) BEHAVIORAL

Non-sealant (toothbrushing)

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[Ismail AI, Sohn W, Tellez M, et al (2007) The International Caries Detection and Assessment System (ICDAS): An integrated system for measuring dental caries: Methods. Community Dent Oral Epidemiol 35:170-178 \].

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Academic Centre for Dentistry in Amsterdam: collaborator
• Universidade Federal de Pernambuco: collaborator

MeSH Terms

Conditions

Dental Caries

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Split-mouth design

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: September 12, 2018
• Study Start: March 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share