Cervical Caries, Dental Caries
Conditions
Keywords
Risk Factor, Patient Outcome Assessment
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.
Interventions
PROCEDURELow 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.
PROCEDURERMGI 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
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Caries | 6 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. |
Outcome results
None listed