NCT06990945

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 22 Years – 42 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a two-year, double-blind, randomized controlled clinical trial designed to compare the clinical performance and radiographic outcomes of a mesoporous bioactive glass adhesive (Hi-Bond Universal) with a conventional universal adhesive (OptiBond Universal) in Class II carious lesions. The trial will enroll 80 participants aged 22 to 42 years, recruited from the Outpatient Clinic of the Conservative Dentistry Department at Cairo University. Eligible participants presenting with ICDAS 5 and 6 carious lesions in posterior permanent teeth will be randomly assigned to one of two treatment groups. The intervention group will receive the Hi-Bond Universal adhesive, a bioactive glass-modified adhesive intended to promote dentin remineralization and reduce postoperative hypersensitivity through calcium and phosphate ion release. The control group will be treated with OptiBond Universal, a conventional adhesive providing mechanical bonding without bioactive properties. Clinical outcomes will be evaluated using the FDI World Dental Federation criteria, focusing on functional properties such as fracture resistance, marginal adaptation, and retention. Radiographic assessments will quantify dentin remineralization using digital grayscale analysis. Hypersensitivity will be recorded using a patient-reported Likert scale at baseline, 6, 12, 18, and 24 months. The primary outcome is the functional integrity of the restorative material, assessed at 24 months. Secondary outcomes include the presence of marginal caries, postoperative hypersensitivity, and radiographic evidence of dentin remineralization. Data will be analyzed using appropriate statistical methods to determine differences between the two adhesive systems.

Conditions

• Dental Caries

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2025-05-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study