An interventional study of Low shrinkage Giomer restorative material (Beautifil II LS) and RMGI alone - Control in Dental Caries and Cervical Caries, sponsored by Cairo University. Not yet recruiting. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 75 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Root Caries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dental Caries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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
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)
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for May 2025; primary completion for Dec 2026, 19 months later.
Of 21 interventional studies with no phase under Root Caries, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 19 months is below that.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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