NCT05891288

Sealing of Initial Occlusal Caries Using Fissure Sealants

Sealing of Initial Occlusal Caries in Fissures of Permanent Molars Using Bioactive Versus Fluoride Releasing Fissure Sealants: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 19 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Caries; Initial

Interventions

Type	Name	Description
OTHER	BioCoat® by Premier®	Bioactive pits and fissure sealant
OTHER	3M™ Clinpro™ Sealant.	Fluoride releasing pits and fissure sealant

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-02-01
• Completion: 2025-03-01
• First posted: 2023-06-06
• Last updated: 2025-03-24

Locations

1 site across 1 country: Egypt