Sealing of Initial Occlusal Caries Using Fissure Sealants

Not Applicable

Completed

• Conditions: Caries; Initial
• Interventions: Other: 3M™ Clinpro™ Sealant.; Other: BioCoat® by Premier®

• Registration Number: NCT05891288
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-06
• Primary Completion: 2025-02-01
• Status Verified: 2025-03
• Study Completion: 2025-03-01
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients with bilateral initial carious fissures in molars showing no signs of caries.
• Co-operative patients approving to participate in the trial.

Exclusion Criteria

• Sound fissures.
• Pregnancy.
• Disabilities.
• Systemic disease or severe medical complications.
• Rampant caries.
• Heavy smoking.
• Xerostomia.
• Lack of compliance.
• Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator group	3M™ Clinpro™ Sealant.	Fluoride releasing resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant
bioactive group	BioCoat® by Premier®	Bioactive Pits \& fissures sealant BioCoat® by Premier®.

Primary Outcome Measures

Name	Time	Method
Retention of sealant	2 years	rate of sealant loss

Secondary Outcome Measures

Name	Time	Method
Caries incidence	2 years	Rate of caries progression

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, El Manial, Egypt