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

May 3, 2017 updated by: Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas

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

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%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

546

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508000
        • Jose Carlos Pettorossi Imparato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 9 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: fissure sealant
single placement of resin-based sealant on occlusal surface and oral hygiene orientation
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).
PLACEBO_COMPARATOR: oral hygiene orientation
single application of water on occlusal surface and oral hygiene orientation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sealants clinical efficacy
Time Frame: Every 6 months up to 12 months
The clinical evaluation will be performed by one blinded examiner. If the surface is sealed, the examiner will classify it according to described by Pardi et al. (2005); if the surface is without material, the examiner will use the International Caries Detection and Assessment System (ICDAS) criteria (Ismail et al., 2007).
Every 6 months up to 12 months
Sealants radiographic efficacy
Time Frame: Every 6 months up to 12 months
The radiographic evaluation will be performed by two blinded examiners, which will evaluate the four patients' radiographies independently, two by two, without knowing the chronological order of them. The efficacy of the treatment will be related to the presence or absence of increasing radiolucent area. They will also classify each radiograph using Ekstrand criteria (Ekstrand et al., 1997) and analyze them in a software (ImageJ 1.49, National Institute of Health, United States of America) in order to make the radiographic subtraction.
Every 6 months up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sealants and oral hygiene orientation costs
Time Frame: Baseline
Treatment costs will be calculated for each treatment technique considering professional costs and procedure costs. In order to calculate the professional cost, the time spent in each session will be converted in hours and multiplied by the medium income of the dentist per hour as related by the Brazilian Ministry of Labour and Employment. To estimate the procedure cost, it will be considered both variable cost, which includes electricity and equipment depreciation, and materials cost. To calculate the equipment depreciation (peripherals, dental chair and instrumental), we will consider their price, the lifespan of five years and a monthly use of 160 hours, resulting in an estimate value per hour. All materials used in each procedure will have their quantity registered. Prices will be inferences from the market value converted in US Dollars.
Baseline
Sealants cost-efficacy
Time Frame: Through study completion (12 months)
The costs of each treatment procedure will be calculated and compared with threshold values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).
Through study completion (12 months)
Impact on children's quality of life of sealants or oral hygiene orientation
Time Frame: 6 and 12 months
The oral health related to quality of life will be measured using a validated questionnaire according to the children's age. The Early Childhood Oral Health Impact Scale (ECOHIS) will be applied with 4-5 years old children and Child Perceptions Questionnaire will be used for 6-9 (CPQ8-10) years old children. They will be applied immediately before the procedure and on 6 months follow-up
6 and 12 months
Children self-reported discomfort
Time Frame: Baseline
The discomfort of each type of treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he/she felt during the treatment immediately after the procedure. This answer should be given solely by the child, which means no parental or professional interferences.
Baseline
Parents' reported satisfaction with treatment
Time Frame: 6 months
The parents'/guardians' satisfaction with treatment will be evaluated using a questionnaire. It will be applied only at the 6-months follow-up.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculty Sao Leopoldo Mandic Campinas

Investigators

  • Principal Investigator: Jose CP Imparato, PhD, Faculty Sao Leopoldo Mandic Campinas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

November 22, 2015

First Submitted That Met QC Criteria

November 25, 2015

First Posted (ESTIMATE)

December 1, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SLM1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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