Clinical Performance of Cervical-margin-relocated Onlay Restorations, Indirect Tooth-colored Onlay Restorations in Posterior Teeth
Conditions
Keywords
cervical margin relocation, marginal adaptation, Indirect onlay restorations, Lithium-disilicate, CAD/CAM composite
Brief summary
This study will evaluate the performance of three different tooth-colored onlay materials in adult patients' posterior teeth. First, investigators will use a bulk-fill composite resin to raise the cavity margin above the gum line and below the contact point. Then each patient will receive three onlays made from different materials. Investigators will follow patients at 2 weeks, 6 months, 18 months, and 24 months to assess how well the onlays fit, function, and whether restorations cause sensitivity or new decay. The results will help dentists choose the most durable onlay restorations for deep-margin elevation cases.
Interventions
OTHERMachinable lithium-disilicate ceramic onlay (IPS e.max CAD)
Single indirect onlay restoration milled from an IPS e.max CAD block and crystallized according to the manufacturer's Instructions for Use, then adhesively luted on a randomized molar under.
OTHERPressed lithium-disilicate ceramic onlay (IPS e.max Press)
Single indirect onlay restoration heat-pressed from an IPS e.max Press ingot and then adhesively luted on a randomized molar under rubber-dam isolation.
OTHERMachinable composite onlay (BRILLIANT Crios)
Single indirect onlay restoration milled from a BRILLIANT Crios block and then adhesively luted on a randomized molar under rubber-dam isolation.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Split-mouth randomized allocation at the tooth level (each participant receives three onlays, one per material).
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains. | Post-cementation baseline (2 weeks), 6, 12, 18, and 24 months | Each onlay will be scored per the Revised 2023 World Dental Federation (FDI) criteria across the specified domains (F1, F2, B1, B2, B3, M2). Outcomes will be summarized as (a) mean (SD) score for each domain, and (b) proportion of restorations rated 1-3 (clinically acceptable) vs 4-5 for each domain. Lower scores indicate better clinical performance. |
Countries
Egypt
Contacts
Primary ContactAli Ihsan AlQurashi
Outcome results
None listed