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

NCT ID: NCT06901453

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-05-01

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.

Conditions

Dental Caries; Cervical Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group 2 (RMGI + Giomer Lamination)

Cavities will be restored using a combination technique where light-cured resin modified glass ionomer (GC Fuji II LC) is applied first, leaving 1.5mm space for Giomer. After selective enamel etching, adhesive will be applied to both enamel and dentin margins as well as the RMGI floor, followed by application of Beautifil II LS Giomer as the final layer.

Group Type: EXPERIMENTAL

RMGI alone - Control

Intervention Type: PROCEDURE

Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured

Group 3 (RMGI alone - Control)

Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured. GC Fuji Varnish will be applied before and after finishing to prevent moisture penetration.

Group Type: ACTIVE_COMPARATOR

Low shrinkage Giomer restorative material (Beautifil II LS)

Intervention Type: PROCEDURE

Enamel margins are etched with 37% phosphoric acid for 15 seconds, then the cavity is bonded using FL bond two-step self-etch adhesive. Giomer is applied in increments (maximum 2mm thickness) and light-cured for 20 seconds with a properly calibrated LED curing light.

Group 1 (Giomer)

Cavities will be restored with low shrinkage Giomer restorative material (Beautifil II LS, Shofu, Japan). After etching enamel margins with 37% phosphoric acid for 15 seconds, FL bond two-step self-etch adhesive will be applied, followed by incremental application of Giomer (maximum 2mm thickness) with light-curing for 20 seconds.

Group Type: ACTIVE_COMPARATOR

RMGI alone - Control

Intervention Type: PROCEDURE

Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured

Interventions

Low shrinkage Giomer restorative material (Beautifil II LS)

Enamel margins are etched with 37% phosphoric acid for 15 seconds, then the cavity is bonded using FL bond two-step self-etch adhesive. Giomer is applied in increments (maximum 2mm thickness) and light-cured for 20 seconds with a properly calibrated LED curing light.

Intervention Type: PROCEDURE

RMGI alone - Control

Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Magdy Eldamanhoury

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CairoU-Bioactive Veneering

Identifier Type: -

Identifier Source: org_study_id