Clinical Trial

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

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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.
Trial Details
NCT Number NCT07407855
Lead Sponsor Cairo University
Conditions Diabetes Mellitus
Enrollment 56 participants
Start Date 2026-08
Primary Completion 2028-05 (estimated)
Study Completion 2028-08 (estimated)
Updated on ClinicalTrials.gov 2026-02-12