NCT03779893

Clinical Evaluation of Bioactive Resin Sealants vs Conventional Sealants in Permanent Molars

Clinical Evaluation of Bioactive Resin Based Pits & Fissures Sealants Versus Conventional Resin Based Pits & Fissures Sealants in Caries Susceptible Fissures in Permanent Molars: A Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 19 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Caries, Dental

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BioCoat® by Premier®.	Bioactive pits and fissure sealant
COMBINATION_PRODUCT	3M™ Clinpro™ Sealant.	conventional pits and fissure sealant

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-01-01
• Completion: 2020-03-01
• First posted: 2018-12-19
• Last updated: 2019-01-15