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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
56
Giomer-based composite restoration (Beautifil® II LS, SHOFU, USA) using universal adhesive (BeautiBond® Xtreme, SHOFU, USA).
Restoration Retention Score Assessed Using Modified USPHS Criteria
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
Marginal Adaptation Score Assessed Using Modified USPHS Criteria
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.
Time frame: Baseline, 6 months, 12 months, and 18 months
Secondary Caries Score Assessed Using Modified USPHS Criteria
Presence of recurrent caries adjacent to the restoration will be assessed using Modified USPHS criteria and recorded as ordinal categorical scores (Alpha, Bravo, Charlie).
Time frame: Baseline, 6 months, 12 months, 18 months
Marginal Discoloration Score Assessed Using Modified USPHS Criteria
Discoloration at the tooth-restoration margin will be evaluated using Modified USPHS criteria and recorded as ordinal categorical scores.
Time frame: Baseline, 6 months, 12 months, 18 months
Post-Operative Sensitivity Score Assessed Using Modified USPHS Criteria
Tooth sensitivity associated with restored teeth will be clinically evaluated and scored using Modified USPHS criteria ordinal scores.
Time frame: Baseline, 6 months, 12 months, 18 months
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