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

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Conditions studied: Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT07407855

Run by

Cairo University

People needed

56

Starts

2026-08-01

Expected to finish

2028-08-01

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult patients with Class V carious lesions (ICDAS scores 3 or 4).
• Controlled diabetic patients diagnosed with diabetes mellitus (for diabetic group).
• Non-diabetic patients with no systemic diseases (for control group).
• Teeth indicated for Class V composite restoration.

You may not qualify if…

• Uncontrolled diabetes mellitus.
• Patients with other systemic diseases affecting oral health.
• Teeth with pulpal involvement or requiring endodontic treatment.
• Patients with parafunctional habits. Pregnant or lactating women

Full record on ClinicalTrials.gov

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