Sealing of Initial Occlusal Caries Using Fissure Sealants

NCT ID: NCT05891288

Last Updated: 2025-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-03-01

Brief Summary

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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

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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

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Caries; Initial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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bioactive group

Bioactive Pits \& fissures sealant BioCoat® by Premier®.

Group Type EXPERIMENTAL

BioCoat® by Premier®

Intervention Type OTHER

Bioactive pits and fissure sealant

Comparator group

Fluoride releasing resin based Pits \& fissures sealant 3M™ Clinpro™ Sealant

Group Type ACTIVE_COMPARATOR

3M™ Clinpro™ Sealant.

Intervention Type OTHER

Fluoride releasing pits and fissure sealant

Interventions

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BioCoat® by Premier®

Bioactive pits and fissure sealant

Intervention Type OTHER

3M™ Clinpro™ Sealant.

Fluoride releasing pits and fissure sealant

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Omar Osama Shaalan

Lecturer, Department of Conservative Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Shaalan

Role: PRINCIPAL_INVESTIGATOR

Lecturer, Department of Conservative Dentistry

Locations

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Faculty of Dentistry, Cairo University

Cairo, El Manial, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Bioactive fissue sealant

Identifier Type: -

Identifier Source: org_study_id

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