Clinical Performance of HVGIC vs Bulk Fill Composite in Class II Cavities of Posterior Teeth: A 12-Month RCT

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

NCT Number	NCT07067164
Lead Sponsor	Ain Shams University
Conditions	Comparison of Bulk Fill vs HVGIC in Class II Cavities
Enrollment	31 participants
Start Date	2025-07
Primary Completion	2026-07 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2025-07-16