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NOT YET RECRUITING
NCT06990945
NA

The Study Aims to Compare the Effectiveness of Mesoporous Bioactive Glass-containing Adhesives vs Conventional Universal Adhesives on the Clinical Performance Composite Restorations Through Promoting Dentin Remineralization After Selective Caries Removal Over a Two-year Follow-up

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

a two-year, double-blind, randomized controlled trial evaluates the effectiveness of a bioactive glass adhesive (Hi-Bond Universal) versus a conventional adhesive (OptiBond Universal) in Class II carious lesions. The study will assess clinical outcomes such as fracture resistance and marginal adaptation and radiographic evidence of dentin remineralization in 80 adult participants. Hypersensitivity and secondary caries development will also be monitored at multiple time points to determine comparative efficacy.

Official title: Clinical Performance And Radiographic Assessment Of Mesoporous Bioactive Glass Adhesive Vs. Universal Adhesive In Class II Carious Lesions

Key Details

Gender

All

Age Range

22 Years - 42 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-10

Completion Date

2027-12

Last Updated

2025-05-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Hi-Bond Universal Adhesive

A bioactive glass adhesive containing mesoporous bioactive glass designed to promote dentin remineralization, manufactured by Mediclus, Korea. It releases calcium and phosphate ions to enhance dentin sealing and reduce hypersensitivity The adhesive will be applied after selective caries removal following a standardized protocol: Selective enamel etching with 37% phosphoric acid for 15 seconds. Application of HI Bond Universal adhesive with agitation for 20 seconds. Light curing for 20 seconds using a LED curing device. Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA). Occlusal adjustment, finishing, and polishing.

DEVICE

OptiBond Universal Adhesive

conventional universal adhesive designed for bonding composite restorations to enamel and dentin. The adhesive will be applied after selective caries removal following a standardized protocol: Selective enamel etching with 37% phosphoric acid for 15 seconds. Application of OptiBond Universal adhesive with agitation for 20 seconds. Light curing for 20 seconds using a LED curing device. Incremental application of a nano-hybrid composite (Optishade Universal Kerr Dental, USA). Occlusal adjustment, finishing, and polishing.

Locations (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt