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

Cairo University (CU)

Status: Begins enrollment in 2 months

Conditions: Diabetes Mellitus

Treatments: Device: Giomer-based composite restoration

Study type: Interventional

Funder types: Other

Identifiers

NCT07407855

CU-FD-CD-4-1-3-2025

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Diabetic Patients

Experimental group

Description:

Controlled diabetic patients with Class V carious lesions restored using Giomer-based composite resin

Treatment:

Device: Giomer-based composite restoration

Non-Diabetic Patients

Active Comparator group

Description:

Non-diabetic patients with Class V carious lesions restored using the same Giomer-based composite and adhesive protocol.

Treatment:

Device: Giomer-based composite restoration