Sealing of Initial Occlusal Caries Using Fissure Sealants

Study Overview
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Brief Summary
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The purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.

Detailed Description
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SmartCap™ Technology, which is used in the novel bioactive fissure sealant, is based on proprietary semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules in BioCoat are packed with ionic fluoride, calcium, and phosphate solutions that diffuse in and out of the sealant. It is hypothesized that fluoride uptake is increased in the presence of calcium and phosphate ions. With little evidence-based information in the literature about using bioactive fissure sealants to seal initial carious lesions, it was determined that a randomized controlled trial would be beneficial in testing the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as fluoride releasing resin-based pits and fissure sealant in fissures with initial caries.

Official Title
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Sealing of Initial Occlusal Caries in Fissures of Permanent Molars Using Bioactive Versus Fluoride Releasing Fissure Sealants: A Randomized Controlled Trial

Conditions
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Caries; Initial

Intervention / Treatment
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* Other: BioCoat® by Premier®
* Other: 3M™ Clinpro™ Sealant.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with bilateral initial carious fissures in molars showing no signs of caries. Co-operative patients approving to participate in the trial. Exclusion Criteria: Sound fissures. Pregnancy. Disabilities. Systemic disease or severe medical complications. Rampant caries. Heavy smoking. Xerostomia. Lack of compliance. Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bioactive group<br>Bioactive Pits & fissures sealant BioCoat® by Premier®. | Other: BioCoat® by Premier®<br>* Bioactive pits and fissure sealant<br>|
| Active Comparator: Comparator group<br>Fluoride releasing resin based Pits & fissures sealant 3M™ Clinpro™ Sealant | Other: 3M™ Clinpro™ Sealant.<br>* Fluoride releasing pits and fissure sealant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention of sealant | rate of sealant loss | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries incidence | Rate of caries progression | 1 year |