NCT06493942

Clinical Efficiency of Bioactive Pit and Fissure Sealant

Clinical Evaluation of Bioactive Versus Filled Resin Based Pit & Fissure Sealants in First Permanent Molars: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 6 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pit and Fissure Sealant

Interventions

Type	Name	Description
OTHER	BioCoat® by Premier®	BioCoat is a 56% filled resin formula that provides added strength and excellent long-term resistance to wear ؤomparable to flowable composites.
OTHER	UltraSeal XT™ plus by Ultradent	UltraSeal XT plus is a 58%-filled resin fluoride-releasing sealant. It is strong and has high wear resistant

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-30
• Completion: 2025-09-30
• First posted: 2024-07-10
• Last updated: 2024-07-10

Regulatory

• FDA-regulated drug study