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Not Yet Recruiting NCT07731308

Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations

Conditions: Class V Dental Caries, Type 2 Diabetes Mellitus, Giomer Technology; Injectable Resin Composite; Zirconia-Modified Glass Ionomer

Sex: All
Ages: 22 Years – 55 Years
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Cairo University

Summary

This randomized controlled clinical trial aims to compare the clinical performance of zirconia-reinforced glass ionomer and injectable giomer restorations in Class V carious lesions among controlled type II diabetic against non-diabetics. One hundred Class V restorations will be allocated equally into four parallel groups according to restorative material and diabetic status. Clinical performance will be evaluated at baseline, 6, 12, and 18 months using the modified United States Public Health Service (USPHS) criteria. The primary outcome is restoration retention, while secondary outcomes include marginal adaptation, marginal discoloration, secondary caries, and postoperative sensitivity.

Eligibility Criteria

Inclusion Criteria: * Male or Female participants from 22 to 55 years * Controlled diabetic and non-diabetic patients consulting the outpatient clinic * Patients categorized as moderate or high caries risk * Patients willing to provide informed consent * Co-operative patients agreeing to participate in the trial Inclusion Criteria for teeth * Teeth with class V carious lesion classified according to the International Caries Detection and Assessment System (ICDAS II) as ICDAS code (4) or ICDAS code (5) * Teeth with normal pulp vitality testing; no signs of inflammation or spontaneous pain before treatment Exclusion Criteria: * Patients with spontaneous or elicited pain from caries. * Systemic illnesses other than diabetes. * Severe bruxism/clenching. * Temporomandibular joint disorders. * Inability to return for recall visits/ Refusal to participate in the study. * Pregnancy. * heavy smoking. * Lack of compliance. Exclusion criteria for teeth * Teeth presenting with spontaneous or elicited pain * A lack of normal pulp vitality testing * Visible or clinical signs of pulpal/periapical inflammation before treatment. * Class V carious lesions that are not classified as ICDAS code (4) or ICDAS code (5).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07731308). StuddyBuddy aggregates publicly available trial information.