Clinical Performance of Giomer-Based Composite Restorations in Class V Carious Lesions in Diabetic and Non-Diabetic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Giomer-based composite restoration.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device Giomer-based composite restoration
Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).
Primary outcome measures
- Restoration Retention Score Assessed Using Modified USPHS Criteria [Time frame: Baseline, 6 months, 12 months, and 18 months]
Secondary outcome measures (4)
- Marginal Adaptation Score Assessed Using Modified USPHS Criteria [Time frame: Baseline, 6 months, 12 months, and 18 months]
- Secondary Caries Score Assessed Using Modified USPHS Criteria [Time frame: Baseline, 6 months, 12 months, 18 months]
- Marginal Discoloration Score Assessed Using Modified USPHS Criteria [Time frame: Baseline, 6 months, 12 months, 18 months]
- Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria [Time frame: Baseline, 6 months, 12 months, 18 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07407855 · CU-FD-CD-4-1-3-2025