Clinical trial NCT06901453: The Effectiveness RMGI and Giomer, Individually and Combined Anterior Cervical Caries
Official title: Effectiveness of RMGI and Giomer, Both Individually and in Combination, for Restoring Anterior Cervical Caries in High-Risk Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Cervical Caries
Keywords: Risk Factor
Patient Outcome Assessment
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Secondary Caries
timeFrame: 6 months
measure: Secondary Caries
timeFrame: 12 months
measure: Secondary Caries
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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