Actively Recruiting
Clinical Performance of HVGIC vs Bulk Fill Composite in Class II Cavities of Posterior Teeth: A 12-Month RCT
Led by Ain Shams University · Updated on 2025-07-16
31
Participants Needed
1
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Clinical Performance of HVGIC vs Bulk Fill Composite in Class II Cavities of Posterior Teeth: A 12-Month RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 45 years
- Systemically healthy individuals
- Patients with at least two Class II carious lesions (one on each side) in permanent posterior teeth
- Vital, symptomless teeth
- Teeth in occlusion and in contact with adjacent natural teeth
- Healthy periodontal tissues
- Carious lesions of moderate depth (outer or middle third of dentin radiographically)
- Patients likely to return for recall visits
You will not qualify if you...
- Medically compromised patients
- Pregnant or breastfeeding women
- Poor oral hygiene
- Patients undergoing orthodontic treatment
- Patients with parafunctional habits (e.g., bruxism)
- Extensive lesions requiring cusp coverage
- Absence of adjacent or opposing teeth
AI-Screening
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Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, Ain Shams University
Cairo, Cairo Governorate, Egypt, 11566
Actively Recruiting
Research Team
N
Noha M Anany, MSc
CONTACT
S
Sara M Abd El-moniem, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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