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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

NCT06990945 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

  • Dental Caries

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.

Sponsors & Collaborators

  • providing support: Equipment and some consumables by Department of Oral Medicine, Periodontology and Oral Diagnosis, Faculty of Dentistry, Cairo University

    collaborator UNKNOWN

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06990945 on ClinicalTrials.gov