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

Phase 1

• Conditions: Caries, Dental
• Interventions: Combination Product: BioCoat® by Premier®.; Combination Product: 3M™ Clinpro™ Sealant.

• Registration Number: NCT03779893
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study First Submitted: 2018-12-17
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Status Verified: 2019-01
• Study Start: 2019-01
• Last Update Submitted: 2019-01-12
• Last Update Posted: 2019-01-15
• Primary Completion: 2020-01
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bioactive group	BioCoat® by Premier®.	Bioactive Pits \& fissures sealant BioCoat® by Premier®.
conventional group	3M™ Clinpro™ Sealant.	Conventional resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant is administrated

Primary Outcome Measures

Name	Time	Method
Retention of sealant	one year	rate of sealant loss

Secondary Outcome Measures

Name	Time	Method
Caries incidence	one year	rate of caries initiation