Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars

Study Overview
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Brief Summary
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This study will be conducted to evaluate the performance; in terms of retention and caries inhibition; of the newly introduced bioactive resin based pits and fissure sealant versus conventional resin based pits and fissure sealant in caries susceptible fissures in posterior molars in patients at risk of caries. Evaluation will be done by visual tactile examination & VistaCAM.

Detailed Description
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In the investigator's study the comparator material will be BioCoat® by Premier® ; new bioactive resin pits and fissures sealant featuring SmartCap™ Technology. SmartCap™ Technology utilizes patented semi-permeable resin microcapsules. In BioCoat, the rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, which diffuse in and out of the sealant. Greater fluoride uptake in the presence of calcium and phosphate ions is assumed. With limited evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it was found beneficial to evaluate the newly introduced material using a randomized controlled trial to test the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as conventional resin based pits and fissure sealant in susceptible fissures.

Official Title
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Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial

Conditions
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Caries, Dental

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria of participants: Patients with bilateral caries susceptible fissures in molars showing no signs of caries. 19 - 40 years. Males or Females. Co-operative patients approving to participate in the trial. Exclusion criteria of participants: Patients younger than 19 years old or older than 40 years old. Pregnancy. Disabilities. Systemic disease or severe medical complications. Allergic history concerning methacrylate. 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: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional group<br>Conventional resin based Pits & fissures sealant 3M™ Clinpro™ Sealant is administrated | Combination Product: 3M™ Clinpro™ Sealant.<br>* conventional pits and fissure sealant<br>|
| Experimental: bioactive group<br>Bioactive Pits & fissures sealant BioCoat® by Premier®. | Combination Product: BioCoat® by Premier®.<br>* Bioactive 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 | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries incidence | rate of caries initiation | one year |