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This study will compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing filled resin based pits and fissure sealant in posterior molars prone to carious lesions of fissures in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.
New bioactive resin pits and fissures sealant BioCoat® by Premier® presenting SmartCap™ Technology involving semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules are filled with ionic solutions of fluoride, calcium and phosphate, supposing greater fluoride uptake in the presence of calcium and phosphate ions.
With no enough evidence based information in literature about using bioactive fissure sealants in susceptible fissures , it isd beneficial to evaluate the newly introduced material using a randomized clinical trial to test the null hypothesis that bioactive resin pit and fissure sealant will have the same clinical performance as flouride releasing filled resin based pit and fissure sealant in susceptible fissures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (A) | Active Comparator | Fluoride releasing filled resin based pit and fissure sealant using UltraSeal XTâ„¢ plus by Ultradent |
|
| Interventional group (B) | Experimental | Bioactive pit and fissure sealant using BioCoat® by Premier® |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioCoat® by Premier® | Other | BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention of sealant | rate of sealant loss | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Caries incidence | Rate of caries progression | 1 year |
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Inclusion Criteria:
Inclusion Criteria of participants:
Inclusion Criteria of teeth:
Exclusion Criteria:
Exclusion criteria of participants:
Exclusion criteria of teeth:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samaa Salah, Msc | Contact | 01009273452 | samaa.salah@dentistry.cu.edu.eg |
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| ID | Term |
|---|---|
| C536528 | Van der Woude syndrome |
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| ID | Term |
|---|---|
| C106663 | Ultra Seal XT |
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Randomized control trial
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Blinding to participants : will not know either the intervention or the comparator will be applied to their teeth Blinding to investigator: covering the 2 syringes with opaque seal to avoid performance bias Blinding to outcomes assessor: to overcome detection bias
| UltraSeal XTâ„¢ plus by Ultradent | Other | UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant |
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