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Clinical Performance of HVGIC vs Bulk Fill Composite in Class II Cavities of Posterior Teeth: A 12-Month RCT
Sponsor: Ain Shams University
Summary
Study Title: Clinical Performance of Highly Viscous Glass Ionomer versus Bulk Fill Resin Composite Restorative Materials in Moderate Class II Cavities of Permanent Posterior Teeth: A 12-Month Randomized Clinical Study Study Design: Split-mouth, randomized clinical trial on 31 patients with at least two moderate Class II carious lesions in permanent posterior teeth. Each patient receives two restorations-bulk fill resin composite on one side and highly viscous glass ionomer (HVGIC) on the other. Aim: To compare the clinical performance of bulk fill resin composite and HVGIC restorations over 1 week (baseline), 6 months, and 12 months using the modified United States Public Health Services (USPHS) criteria. Primary Outcome: Marginal adaptation of the restorations Secondary Outcomes: 1. Anatomic form 2. Contact point 3. Restoration retention 4. Marginal discoloration 5. Surface texture 6. Color match 7. Secondary caries 8. Postoperative sensitivity Methodology Highlights: Evaluation by two blinded examiners Standardized cavity prep and material application Clinical evaluation using USPHS criteria at all follow-up intervals Statistical analysis with chi-square, ANOVA, or non-parametric tests as appropriate (R software v4.3.2) Ethical Considerations: Approved by the Faculty of Dentistry, Ain Shams University Research Ethics Committee Informed consent will be obtained from all participants Significance: This study helps determine whether HVGIC can be a clinically viable alternative to bulk fill resin composite in moderate Class II cavities, with implications for durability, patient compliance, and cost-effectiveness
Official title: Clinical Performance of Highly Viscous Glass Ionomer Versus Bulk Fill Resin Composite Restorative Materials in Moderate Class II Cavities of Permanent Posterior Teeth " A 12-Month Randomized Clinical Study"
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2025-07
Completion Date
2026-09
Last Updated
2025-07-16
Healthy Volunteers
Yes
Interventions
Bulk fill resin composite restorative material
Both restorative materials were applied in a clinical setting following standard infection control protocols and material-specific preparation techniques. The interventions were performed by the same calibrated operator to ensure consistency, and evaluated using modified USPHS criteria by two blinded, independent assessors at 1 week (baseline), 6 months, and 12 months. The study employed a split-mouth design to allow direct intra-individual comparison between the two materials under similar oral conditions.
Locations (1)
Faculty of Dentistry, Ain Shams University
Cairo, Cairo Governorate, Egypt