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

NCT06901453 | Not Yet Recruiting DMC

• 1 other identifier: CairoU-Bioactive Veneering
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries; Cervical Caries

Keywords

Risk Factor; Patient Outcome Assessment

Outcome Measures

Primary Outcomes (3)

• Secondary Caries

  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.

  6 months

• Secondary Caries

  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.

  12 months

• Secondary Caries

  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.

  18 months

Study Arms (3)

Group 2 (RMGI + Giomer Lamination)

EXPERIMENTAL

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.

Procedure: RMGI alone - Control

Group 3 (RMGI alone - Control)

ACTIVE COMPARATOR

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.

Procedure: Low shrinkage Giomer restorative material (Beautifil II LS)

Group 1 (Giomer)

ACTIVE COMPARATOR

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.

Procedure: RMGI alone - Control

Interventions

Low shrinkage Giomer restorative material (Beautifil II LS) 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 3 (RMGI alone - Control)

RMGI alone - Control 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 1 (Giomer); Group 2 (RMGI + Giomer Lamination)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries; Root Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors (A.Y. \& D.E.), who are experienced clinicians responsible for evaluating the restorations at each follow-up period (baseline, 6, 12, and 18 months), are kept completely unaware of which treatment each patient received. They evaluate all restorations using standardized criteria without knowledge of the group allocation. Additionally, the statistician who analyzes the collected data is also blinded to the treatment groups during the statistical analysis process, ensuring unbiased interpretation of results.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: This randomized controlled trial compares three bioactive restorative materials (Giomer, RMGI veneered with Giomer, and RMGI alone) for treating anterior cervical caries in high-risk patients. 75 participants (25 per group) will be evaluated over 18 months for secondary caries (primary outcome), restoration integrity, appearance, and sensitivity using modified USPHS criteria at baseline, 6, 12, and 18 months. The parallel-group superiority design with 1:1:1 allocation will include blinded outcome assessment at the Conservative Dentistry Department, Cairo University.

Study Record Dates

• First Submitted: March 23, 2025
• First Posted: March 30, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share