Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations | NCT07731308

NCT07731308

Overview

NCT ID: NCT07731308
Lead Sponsor: Cairo UniversityOTHER
Official Title: Clinical Performance of Zirconia-Reinforced Glass Ionomer Versus Injectable Giomer in Class V Restorations of Diabetic and Non Diabetic Patients: 18 Months Controlled Clinical Trial
Brief 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.
Conditions: Class V Dental Caries, Type 2 Diabetes Mellitus

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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).

Central Contacts: Mohamed Ayman Hamdy AymanContact
mohamed.ayman@dentistry.cu.edu.eg