Sealing of Initial Occlusal Caries Using Fissure Sealants

March 20, 2025 updated by: Omar Osama Shaalan, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Manial
      • Cairo, El Manial, Egypt, 11553
        • Faculty of Dentistry, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bioactive group
Bioactive Pits & fissures sealant BioCoat® by Premier®.
Other: BioCoat® by Premier®
Bioactive pits and fissure sealant
Active Comparator: Comparator group
Fluoride releasing resin based Pits & fissures sealant 3M™ Clinpro™ Sealant
Other: 3M™ Clinpro™ Sealant.
Fluoride releasing pits and fissure sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention of sealant
Time Frame: 2 years
rate of sealant loss
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries incidence
Time Frame: 2 years
Rate of caries progression
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Omar Shaalan, Lecturer, Department of Conservative Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

May 22, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • Bioactive fissue sealant

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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