Sealing of Initial Occlusal Caries Using Fissure Sealants

Caries; Initial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05891288
• Other study ID #: Bioactive fissue sealant
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: Omar Shaalan
• Phone: 01122665661
• Email: omar.shaalan[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: August 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries; Initial

Intervention

Other:
• BioCoat® by Premier®
Bioactive pits and fissure sealant
• 3M™ Clinpro™ Sealant.
Fluoride releasing pits and fissure sealant

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo	El Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of sealant	rate of sealant loss	1 year
Secondary	Caries incidence	Rate of caries progression	1 year