Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Resin Sealing in Deciduous and Permanent Molars: Split-mouth Randomized Clinical Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: High cost
* Procedure: Low Cost


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Split-mouth
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Cost<br>Restoration using a high-cost sealant | Procedure: High cost<br>* Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.<br>|
| Experimental: Low Cost<br>Restoration using a low-cost sealant | Procedure: Low Cost<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dental caries progression | 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. | Every 6 months up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | The costs of each treatment procedure will be calculated and compared with thresholds values for intervention costeffectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/). | 18 months | 
| Impact on children's quality of life | 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) | Baseline and 18 months | 
| Children self-reported discomfort | 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. | Baseline | 
| Sealant retention | 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. | Every 6 months up to 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental caries, molars, Pit and Fissure Sealants