HVGIC versus bulk‑fill composite for moderate Class II posterior cavities
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"
This study will test whether highly viscous glass ionomer or a bulk‑fill resin composite works better for moderate Class II cavities in adults who have at least two such lesions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 31 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07067164 on ClinicalTrials.gov |
What this trial studies
In a prospective, randomized split‑mouth design, 31 adult patients with at least two moderate Class II lesions receive one HVGIC restoration on one side and a bulk‑fill resin composite on the other. Restorations are evaluated at baseline (1 week), 6 months, and 12 months using the modified USPHS criteria with marginal adaptation as the primary outcome. Secondary outcomes include anatomic form, contact point, retention, marginal discoloration, surface texture, color match, secondary caries, and postoperative sensitivity. The trial is conducted at the Faculty of Dentistry, Ain Shams University in Cairo.
Who should consider this trial
Good fit: Adults aged 18–45 who are systemically healthy with at least two moderate Class II carious lesions in permanent posterior teeth, vital symptom‑free teeth, and good periodontal health are ideal candidates.
Not a fit: Patients who are medically compromised, pregnant or breastfeeding, have poor oral hygiene, bruxism, extensive lesions needing cusp coverage, or fewer than two eligible lesions are unlikely to qualify or derive benefit.
Why it matters
Potential benefit: If successful, the results could help clinicians choose a simpler or more durable restorative material and reduce the need for repairs or replacements.
How similar studies have performed: Previous short‑term clinical studies have shown comparable 6–12 month performance for modern bulk‑fill composites and improved HVGIC formulations, but long‑term comparative data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cairo, Cairo Governorate
- Faculty of Dentistry, Ain Shams University — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed A Kamel, PhD — Associate Professor of Operative Dentistry Faculty of Dentistry Ain Shams University
- Study coordinator: Noha M Anany, MSc
- Email: nohaanany252@gmail.com
- Phone: 002/01000511714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.