NCT07067164 Clinical Performance of HVGIC vs Bulk Fill Composite in Class II Cavities of Posterior Teeth: A 12-Month RCT
| NCT ID | NCT07067164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ain Shams University |
| Condition | Comparison of Bulk Fill vs HVGIC in Class II Cavities |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2025-07 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 31 participants in total. It began in 2025-07 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 to 45 years 2. Systemically healthy individuals 3. Patients with at least two Class II carious lesions (one on each side) in permanent posterior teeth 4. Vital, symptomless teeth 5. Teeth in occlusion and in contact with adjacent natural teeth 6. Healthy periodontal tissues 7. Carious lesions of moderate depth (outer or middle third of dentin radiographically) 8. Patients likely to return for recall visits Exclusion Criteria: 1. Medically compromised patients 2. Pregnant or breastfeeding women 3. Poor oral hygiene 4. Patients undergoing orthodontic treatment 5. Patients with parafunctional habits (e.g., bruxism) 6. Extensive lesions requiring cusp coverage 7. Absence of adjacent or opposing teeth
Contact & Investigator
Mohamed A Kamel, PhD
PRINCIPAL INVESTIGATOR
Associate Professor of Operative Dentistry Faculty of Dentistry Ain Shams University
Frequently Asked Questions
Who can join the NCT07067164 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Comparison of Bulk Fill vs HVGIC in Class II Cavities. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07067164 currently recruiting?
Yes, NCT07067164 is actively recruiting participants. Contact the research team at nohaanany252@gmail.com for enrollment information.
Where is the NCT07067164 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07067164 clinical trial?
NCT07067164 is sponsored by Ain Shams University. The principal investigator is Mohamed A Kamel, PhD at Associate Professor of Operative Dentistry Faculty of Dentistry Ain Shams University. The trial plans to enroll 31 participants.