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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bioactive group | Experimental | Bioactive Pits & fissures sealant BioCoat® by Premier®. |
|
| Comparator group | Active Comparator | Fluoride releasing resin based Pits & fissures sealant 3M™ Clinpro™ Sealant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioCoat® by Premier® | Other | Bioactive pits and fissure sealant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of sealant | rate of sealant loss | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Caries incidence | Rate of caries progression | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omar Shaalan | Lecturer, Department of Conservative Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | El Manial | 11553 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41381619 | Derived | Abdelsalam AF, Shaalan O. 24-month efficacy of bioactive versus fluoride sealant for non-cavitated occlusal caries in adults: a randomized clinical trial. Sci Rep. 2025 Dec 11;15(1):43738. doi: 10.1038/s41598-025-29730-8. |
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| 3M™ Clinpro™ Sealant. |
| Other |
Fluoride releasing pits and fissure sealant |
|