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NOT YET RECRUITING
NCT07407855
NA

Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

Diabetes mellitus is associated with structural and biochemical alterations in dentin that may negatively affect the clinical performance and longevity of adhesive dental restorations, particularly in cervical carious lesions. Giomer-based composite resins, containing pre-reacted glass ionomer fillers, release fluoride and other beneficial ions that may enhance remineralization and reduce the risk of secondary caries. This prospective, parallel-group, non-randomized clinical trial aims to evaluate the clinical performance of Giomer-based composite restorations in Class V carious lesions in controlled diabetic and non-diabetic patients. Restorations will be assessed using Modified USPHS criteria at baseline, 6, 12, and 18 months, with retention as the primary outcome and marginal adaptation, secondary caries, marginal discoloration, and post-operative sensitivity as secondary outcomes.

Official title: Comparative Evaluation of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic Versus Non-Diabetic Patients Using Modified USPHS Criteria: An 18-Month Non-Randomized Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

56

Start Date

2026-08

Completion Date

2028-08

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DEVICE

Giomer-based composite restoration

Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).