Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT07157410
Clinical Evaluation of Indirect Tooth-Colored Onlays With Cervical Margin Relocation
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
20 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Molar tooth with proximal subgingival carious lesion of ICDAS 4 or 5, causing weakening of one or more cusps.
- Normal alignment with the adjacent and opposing teeth.
- Acceptance of the follow-up period and recall visits for 2 years.
Exclusion criteria
- Distance between the gingival margin and the crestal bone < 2 mm.
- The tooth would require direct pulp capping.
- Poor oral hygiene (or not completing the oral hygiene phase).
- Chronic periodontitis.
- Pulpitis or non-vital tooth.
- Orthodontic treatment.
- Parafunctional habits.
- Systemic disease.
- Pregnancy.
- Teeth act as abutment for fixed or removable prosthesis.
- Occlusion of fewer than 20 teeth
Treatment and study plan
Machinable lithium-disilicate ceramic onlay (IPS e.max CAD)
OtherSingle 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.
Pressed lithium-disilicate ceramic onlay (IPS e.max Press)
OtherSingle indirect onlay restoration heat-pressed from an IPS e.max Press ingot and then adhesively luted on a randomized molar under rubber-dam isolation.
Machinable composite onlay (BRILLIANT Crios)
OtherSingle indirect onlay restoration milled from a BRILLIANT Crios block and then adhesively luted on a randomized molar under rubber-dam isolation.
Primary outcomes
-
FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains.
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Mansoura University
Other
Registry information
Official study title
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
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Sep 5, 2025
- Registry last updated
- Sep 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.