Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06493942
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-02
Brief Title:
Clinical Efficiency of Bioactive Pit and Fissure Sealant
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Clinical Evaluation of Bioactive Versus Filled Resin Based Pit Fissure Sealants in First Permanent Molars A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None