Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children (SLM1661)

Faculty Sao Leopoldo Mandic Campinas

Status: Completed

Conditions: Fissure Sealants; Oral Hygiene Orientation

Treatments: Other: oral hygiene orientation; Other: fissure sealant

Study type: Interventional

Funder types: Other

Identifiers

NCT02617940

SLM1

Details and patient eligibility

About

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%.

Enrollment: 546 patients

Sex: All

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• parents or legal guardians accept and sign the informed consent form.
• children must have at least one molar with caries lesion classified as ICDAS active score 3.

Exclusion criteria

• children with special needs and/or systemic diseases with oral impairment.
• teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, cavitated caries lesions in dentin or other types of formation defects.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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546 participants in 2 patient groups, including a placebo group

fissure sealant

Experimental group

Description:

single placement of resin-based sealant on occlusal surface and oral hygiene orientation

Treatment:

Other: fissure sealant

oral hygiene orientation

Placebo Comparator group

Description:

single application of water on occlusal surface and oral hygiene orientation

Treatment:

Other: oral hygiene orientation