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Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03819868
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Information provided by (Responsible Party):
Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas

Brief Summary:
The sealing of fossae and fissures is an effective procedure in preventing occlusal caries lesions. However, there are gaps regarding its efficacy in the treatment of initial enamel lesions. In addition, there are no studies in the literature that have compared the longevity of sealings performed with the different sealants available in the market. Thus, the objective of this study is to evaluate the efficacy of fossae and fissures sealings performed with a low-cost resinous sealant in occlusal lesions in enamel in permanent and deciduous molars. This is a multicenter clinical study of non-inferiority, randomized, controlled, double blind (patient and operator) with 60 deciduous molars and 340 permanent molars of children 4 and 9 years of age. The sample unit will be the tooth, which will be randomized into two groups using a distributed randomization list in mixed envelopes that will be open only at the time of the procedure. The teeth allocated in the test group will be treated with the sealant preventâ; Those allocated in the control group will employ the Fluroshieldâ sealant. In both groups the procedure will follow the manufacturer's standards. The efficacy of the sealant will be evaluated by means of clinical and radiographic control at 6, 12 and 18 months after the procedure. Secondary outcomes, such as retention, cost, acceptability and quality of life, will also be evaluated.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: High cost Procedure: Low Cost Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Split-mouth
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Resin Sealing in Deciduous and Permanent Molars: Split-mouth Randomized Clinical Trial
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Active Comparator: High Cost
Restoration using a high-cost sealant
Procedure: High cost
Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.

Experimental: Low Cost
Restoration using a low-cost sealant
Procedure: Low Cost
Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.

Primary Outcome Measures :
  1. Dental caries progression [ Time Frame: Every 6 months up to 18 months ]

    Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as:

    • Present progression: Increased radiolucidity area of the Lesion
    • Absent progression: No increase in the area of radiolucidity of the lesion.

Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 18 months ]
    The costs of each treatment procedure will be calculated and compared with thresholds values for intervention costeffectiveness by region, determined by World Health Organization (

  2. Impact on children's quality of life [ Time Frame: Baseline and 18 months ]

    The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children. The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old children (Martins et al., 2009).

    They will be applied immediately before the procedure and on 18 months follow-up and we will measure the difference between answers at baseline and the end of treatment (18months)

  3. Children self-reported discomfort [ Time Frame: Baseline ]
    The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988). The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences. Each face corresponds to a number, within a numeric scale from 0 to 5, with 0 no discomfort and 5 the greatest discomfort. At the end, the averages of each score will be compared between the experimental groups.

  4. Sealant retention [ Time Frame: Every 6 months up to 18 months ]

    The elements submitted to the treatment will be codified in accordance with Hesse et al. (2012):

    • Full retention: When the restorer material was Intact when subjected to clinical examination;
    • Partial loss: When there was a loss of a part of the restorer material previously applied;
    • Total Loss: When the restorer material has been lost in its entirety.

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children with at least two deciduous and/or permanent molars with occlusal caries lesions scores 1, 2 or 3 of the Icdas (Ismail et al., 2007) will be included, one on each side, preferably from the same arch.

Exclusion Criteria:

  • Patients with special needs;
  • using orthodontic appliances;
  • with systemic diseases;
  • Teeth that present restorations, sealants, formation defects, deep caries lesions that may lead to pulp impairment;
  • teeth with fistula and/or abscess;
  • teeth with spontaneous painful symptomatology.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03819868

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Contact: Jose Carlos P Imparato, PhD +5511998686008

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Faculty Sao Leopoldo Mandic Recruiting
Campinas, Sao Paulo, Brazil, 13045755
Contact: Jose Carlos P Imparato, PhD    +551935183601   
Sponsors and Collaborators
Faculty Sao Leopoldo Mandic Campinas

Publications of Results:
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Responsible Party: Jose Carlos P Imparato, PhD, Senior Lecturer, Clinical Professor, Faculty Sao Leopoldo Mandic Campinas Identifier: NCT03819868     History of Changes
Other Study ID Numbers: SLM 5
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jose Carlos P Imparato, Faculty Sao Leopoldo Mandic Campinas:
dental caries
Pit and Fissure Sealants
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases