Diabetes Mellitus
Conditions
Brief 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.
Interventions
DEVICEGiomer-based composite restoration
Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).
Sponsors
Cairo University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration Retention Score Assessed Using Modified USPHS Criteria | Baseline, 6 months, 12 months, and 18 months | Retention of Class V Giomer-based composite restorations will be evaluated using Modified United States Public Health Service (USPHS) criteria. Each restoration will be assigned an ordinal score (Alpha, Bravo, Charlie) based on the presence or loss of restoration. Data will be reported as distribution of USPHS scores and frequency of restoration loss over time. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal Adaptation Score Assessed Using Modified USPHS Criteria | Baseline, 6 months, 12 months, and 18 months | Marginal integrity between tooth and restoration will be evaluated using Modified USPHS criteria. Each restoration will receive an ordinal score (Alpha, Bravo, Charlie) at each follow-up visit. |
| Secondary Caries Score Assessed Using Modified USPHS Criteria | Baseline, 6 months, 12 months, 18 months | Presence of recurrent caries adjacent to the restoration will be assessed using Modified USPHS criteria and recorded as ordinal categorical scores (Alpha, Bravo, Charlie). |
| Marginal Discoloration Score Assessed Using Modified USPHS Criteria | Baseline, 6 months, 12 months, 18 months | Discoloration at the tooth-restoration margin will be evaluated using Modified USPHS criteria and recorded as ordinal categorical scores. |
| Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria | Baseline, 6 months, 12 months, 18 months | Tooth sensitivity associated with restored teeth will be clinically evaluated and scored using Modified USPHS criteria ordinal scores. |
Contacts
CONTACTRadwa Wael Ellahouny
Outcome results
None listed