This trial is active, not recruiting.

Conditions fissure sealants, oral hygiene orientation
Treatments fissure sealant, oral hygiene orientation
Sponsor Faculty Sao Leopoldo Mandic Campinas
Start date May 2015
End date December 2015
Trial size 546 participants
Trial identifier NCT02617940, SLM1


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%.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, outcomes assessor)
Primary purpose treatment
single placement of resin-based sealant on occlusal surface and oral hygiene orientation
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).
(Placebo Comparator)
single application of water on occlusal surface and oral hygiene orientation
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.

Primary Outcomes

Sealants clinical efficacy
time frame: Every 6 months up to 12 months
Sealants radiographic efficacy
time frame: Every 6 months up to 12 months

Secondary Outcomes

Sealants and oral hygiene orientation costs
time frame: Baseline
Sealants cost-efficacy
time frame: Through study completion (12 months)
Impact on children's quality of life of sealants or oral hygiene orientation
time frame: 6 and 12 months
Children self-reported discomfort
time frame: Baseline
Parents' reported satisfaction with treatment
time frame: 6 months

Eligibility Criteria

Male or female participants from 4 years up to 9 years old.

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.

Additional Information

Official title Effectiveness of Sealants in Cavitated Enamel Lesions on Occlusal Surfaces of Primary and Permanent Molars in Children
Principal investigator Jose CP Imparato, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Faculty Sao Leopoldo Mandic Campinas.