NCT02617940

Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children

Effectiveness of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces of Primary and Permanent Molars in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 546 (actual)
• Sponsor: Faculty Sao Leopoldo Mandic Campinas · Academic / Other
• Sex: All
• Age: 4 Years – 9 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Fissure Sealants
• Oral Hygiene Orientation

Interventions

Type	Name	Description
OTHER	fissure sealant	Surfaces allocated to this group will be treated with resin-based sealant (FluroShield®, Dentsply, United States of America) according to the manufacturer's instructions. Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 30 seconds, followed by spray of water/air for at least 15 seconds. The sealant will be dispensed on the occlusal surface and light cured for 20 seconds (Optilight Max, Gnatus, Brazil).
OTHER	oral hygiene orientation	Surfaces allocated to this group will be treated with sterile water application, as a placebo, without anesthesia and rubber dam. The active treatment in this group will be only oral hygiene orientations.

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-12-01
• Completion: 2016-12-01
• First posted: 2015-12-01
• Last updated: 2017-05-05

Locations

1 site across 1 country: Brazil