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Clinical Trial Summary

The aim of this study is to evaluate the efficacy of oral hygiene orientation singly, compared to resin-based sealants in controlling occlusal cavitated enamel lesions on primary and permanent molars. For this, 273 occlusal surfaces of primary molars and 273 occlusal surfaces of first permanent molars on 4-9 years-old children with an enamel cavitated lesion will be selected in 9 cities of Brazil. The surfaces will be randomly divides into 2 groups: oral hygiene orientation and resin-based sealant. The surfaces will be evaluated after 6 and 12 months regarding clinical and radiographic lesions progression. The costs and cost-efficacy of these treatments, children's discomfort, parents'/guardians' satisfaction and impact on quality of life will also be investigated. Poisson regression analysis will be performed in order to compare the groups, through clinical and radiographic criteria. This test will also be used to assess the association between the group and patient discomfort and parents' satisfaction. Time, costs and impact on quality of life of the treatments will be compared by Student's t test. For all analyses, the significance level will be set at 5%.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02617940
Study type Interventional
Source Faculty Sao Leopoldo Mandic Campinas
Contact
Status Completed
Phase N/A
Start date May 2015
Completion date December 2016

See also
  Status Clinical Trial Phase
Completed NCT05475145 - Sealing of Occlusal Dentin Caries in Primary Molars. N/A