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Sealing of Initial Occlusal Caries Using Fissure Sealants

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05891288
Collaborator
(none)
36
Enrollment
1
Location
2
Arms
13
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: BioCoat® by Premier®
  • Other: 3M™ Clinpro™ Sealant.
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Sealing of Initial Occlusal Caries in Fissures of Permanent Molars Using Bioactive Versus Fluoride Releasing Fissure Sealants: A Randomized Controlled Trial
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Retention of sealant [1 year]

    rate of sealant loss

Secondary Outcome Measures

  1. Caries incidence [1 year]

    Rate of caries progression

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Cairo University Cairo El Manial Egypt 11553

Sponsors and Collaborators

  • Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Omar Osama Shaalan, Lecturer, Department of Conservative Dentistry, Cairo University
ClinicalTrials.gov Identifier:
NCT05891288
Other Study ID Numbers:
  • Bioactive fissue sealant
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 6, 2023