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Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial

NCT03819868 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-12-10

No results posted yet for this study

Summary

The sealing of fossae and fissures is an effective procedure in preventing occlusal caries lesions. However, there are gaps regarding its efficacy in the treatment of initial enamel lesions. In addition, there are no studies in the literature that have compared the longevity of sealings performed with the different sealants available in the market. Thus, the objective of this study is to evaluate the efficacy of fossae and fissures sealings performed with a low-cost resinous sealant in occlusal lesions in enamel in permanent and deciduous molars. This is a multicenter clinical study of non-inferiority, randomized, controlled, double blind (patient and operator) with 60 deciduous molars and 340 permanent molars of children 4 and 9 years of age. The sample unit will be the tooth, which will be randomized into two groups using a distributed randomization list in mixed envelopes that will be open only at the time of the procedure. The teeth allocated in the test group will be treated with the sealant preventâ; Those allocated in the control group will employ the Fluroshieldâ sealant. In both groups the procedure will follow the manufacturer's standards. The efficacy of the sealant will be evaluated by means of clinical and radiographic control at 6, 12 and 18 months after the procedure. Secondary outcomes, such as retention, cost, acceptability and quality of life, will also be evaluated.

Conditions

  • Dental Caries

Interventions

PROCEDURE

High cost

Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.

PROCEDURE

Low Cost

Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.

Sponsors & Collaborators

  • Faculty Sao Leopoldo Mandic Campinas

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-15
Primary Completion
2019-02-15
Completion
2019-12-31

Countries

  • Brazil

Study Locations

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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 NCT03819868 on ClinicalTrials.gov