Clinical trial NCT02617940: Efficacy of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces in Children
Official title: Effectiveness of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces of Primary and Permanent Molars in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fissure Sealants
Oral Hygiene Orientation
Keywords: dental caries
primary tooth
resin-based sealants
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 546
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%.


Eligibility criteria: 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.

Primary outcomes:
measure: Sealants clinical efficacy
timeFrame: Every 6 months up to 12 months
measure: Sealants radiographic efficacy
timeFrame: Every 6 months up to 12 months
Secondary outcomes:
measure: Sealants and oral hygiene orientation costs
timeFrame: Baseline
measure: Sealants cost-efficacy
timeFrame: Through study completion (12 months)
measure: Impact on children's quality of life of sealants or oral hygiene orientation
timeFrame: 6 and 12 months
measure: Children self-reported discomfort
timeFrame: Baseline
measure: Parents' reported satisfaction with treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Jose Carlos Pettorossi Imparato
Study officials:
affiliation: Faculty Sao Leopoldo Mandic Campinas
name: Jose CP Imparato, PhD
role: PRINCIPAL_INVESTIGATOR
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