Three tooth-colored onlays for molars after cervical margin relocation
Two-year Clinical Evaluation of Different Indirect Tooth-colored Onlay Restorations Placed in Posterior Teeth With Cervical Margin Relocation and Laboratory Investigation of Marginal Adaptation
This study will test three tooth-colored onlay materials in adults with deep molar cavities to see which fits best, lasts longest, and causes the least sensitivity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT07157410 on ClinicalTrials.gov |
What this trial studies
Adult patients with posterior molar teeth that have deep proximal carious lesions will undergo cervical margin relocation using a bulk-fill composite to raise the margin above the gum line. Each participant will receive three different indirect onlays—machinable lithium-disilicate (IPS e.max CAD), pressed lithium-disilicate (IPS e.max Press), and a machinable composite (BRILLIANT Crios)—placed on comparable sites. Investigators will follow participants at 2 weeks, 6 months, 18 months, and 24 months to record marginal adaptation, restoration function, tooth sensitivity, and the development of new caries. The within-patient comparison is intended to reduce variability and help identify which material offers the best clinical performance in deep-margin elevation cases.
Who should consider this trial
Good fit: Adults with a molar that has a subgingival proximal carious lesion (ICDAS 4–5), normal tooth alignment, and willingness to attend a 2-year follow-up are ideal candidates.
Not a fit: Patients with active periodontal disease, a tooth requiring pulp capping or non-vital teeth, systemic conditions, pregnancy, parafunctional habits, or who cannot complete oral hygiene or follow-up visits are unlikely to benefit.
Why it matters
Potential benefit: If successful, the results could help dentists choose onlay materials that last longer and cause fewer complications for deep-margin restorations.
How similar studies have performed: Previous laboratory and clinical reports support lithium-disilicate and composite onlays and show promising results for cervical margin relocation, but direct head-to-head long-term comparisons remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Molar tooth with proximal subgingival carious lesion of ICDAS 4 or 5, causing weakening of one or more cusps. 2. Normal alignment with the adjacent and opposing teeth. 3. Acceptance of the follow-up period and recall visits for 2 years. Exclusion Criteria: 1. Distance between the gingival margin and the crestal bone \< 2 mm. 2. The tooth would require direct pulp capping. 3. Poor oral hygiene (or not completing the oral hygiene phase). 4. Chronic periodontitis. 5. Pulpitis or non-vital tooth. 6. Orthodontic treatment. 7. Parafunctional habits. 8. Systemic disease. 9. Pregnancy. 10. Teeth act as abutment for fixed or removable prosthesis. 11. Occlusion of fewer than 20 teeth
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Faculty of Dentistry, Mansoura University — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Ali Ihsan AlQurashi
- Email: ali1ihsan93@gmail.com
- Phone: +9647813003774
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.