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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional group | Active Comparator | Conventional resin based Pits & fissures sealant 3M™ Clinpro™ Sealant is administrated |
|
| bioactive group | Experimental | Bioactive Pits & fissures sealant BioCoat® by Premier®. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioCoat® by Premier®. | Combination Product | Bioactive pits and fissure sealant |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Retention of sealant | rate of sealant loss | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Caries incidence | rate of caries initiation | one year |
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Inclusion Criteria of participants:
Exclusion criteria of participants:
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 3M™ Clinpro™ Sealant. |
| Combination Product |
conventional pits and fissure sealant |
|