Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Dental Caries

Clinical Trial Details

NCT number	NCT03819868
Study type	Interventional
Source	Faculty Sao Leopoldo Mandic Campinas
Contact	Jose Carlos P Imparato, PhD
Phone	+5511998686008
Email	jimparato@usp.br
Status	Recruiting
Phase	N/A
Start date	August 15, 2017
Completion date	December 2019

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