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OpenTrials
Completed

NCT Number: NCT05891288

Sealing of Initial Occlusal Caries Using Fissure Sealants

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.

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Key information

Conditions

Age range

19 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Cairo University

Cairo, El Manial, 11553, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BioCoat® by Premier®

Other

Bioactive pits and fissure sealant

3M™ Clinpro™ Sealant.

Other

Fluoride releasing pits and fissure sealant

Primary outcomes

  1. Retention of sealant

    Time frame: 2 years

    rate of sealant loss

Secondary outcomes

  1. Caries incidence

    Time frame: 2 years

    Rate of caries progression

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2023
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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