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

Sponsor
Cairo University
Study ID
NCT07407855
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Feb 12, 2026
Start date
Aug 31, 2026
Status verified
Feb 2026
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Diabetic Patients
    Controlled diabetic patients with Class V carious lesions restored using Giomer-based composite resin
  • Active Comparator: Non-Diabetic Patients
    Non-diabetic patients with Class V carious lesions restored using the same Giomer-based composite and adhesive protocol.

Primary Outcome Measure

Restoration Retention Score Assessed Using Modified USPHS Criteria [ Time Frame: Baseline, 6 months, 12 months, and 18 months ]

Central Contacts

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