The Effectiveness RMGI and Giomer, Individually and Combined Anterior Cervical Caries

Not Applicable

Not yet recruiting

• Conditions: Dental Caries; Cervical Caries

• Registration Number: NCT06901453
• Lead Sponsor: Cairo University

Brief Summary

This study compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer. The 18-month randomized clinical trial will assess 75 patients (25 per group), primarily evaluating secondary caries formation, with additional measurements of restoration integrity, appearance, and sensitivity at baseline, 6, 12, and 18 months.

Detailed Description

This study aims to evaluate the clinical performance of three different restorative materials for treating anterior cervical caries in high-risk patients over 18 months. The research will compare resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer (lamination technique). The randomized controlled clinical trial will involve 75 patients, with 25 patients in each treatment group. The primary outcome is secondary caries assessment, while secondary outcomes include fracture, retention, marginal integrity, marginal discoloration, anatomic form, surface texture, and postoperative sensitivity. Assessments will occur at baseline, 6, 12, and 18 months using modified USPHS criteria.

The rationale behind this study is that high-risk caries patients need restorative materials that provide both protection against recurrent decay and aesthetic outcomes. The bioactive properties of these materials, including fluoride release and remineralization capabilities, make them potentially suitable for these patients. The research protocol includes detailed methods for patient selection, randomization, blinding, treatment procedures, follow-up assessments, and statistical analysis. The study is self-funded and will be conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University, with appropriate ethical approvals and informed consent.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-23
• Study First Submitted QC: 2025-03-23
• Last Update Submitted: 2025-03-23
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Study Start: 2025-05-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Patient age range from 18-55 years
• Presence of anterior cervical caries on the labial surface (ICDAS 4 & 5)
• High caries risk
• Good general health

Exclusion Criteria

• Severe or chronic periodontal disease
• Bruxism
• Non-vital teeth
• Fractured or cracked teeth
• Defective restorations
• Pregnancy and/or lactation
• Allergy to the main components of the products to be used in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Secondary Caries	18 months	The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.