Clinical Evaluation of Indirect Tooth-Colored Onlays With Cervical Margin Relocation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Machinable lithium-disilicate ceramic onlay (IPS e.max CAD), Pressed lithium-disilicate ceramic onlay (IPS e.max Press), Machinable composite onlay (BRILLIANT Crios).
- Who it may be relevant to
- Registry conditions: Indirect Tooth-colored Onlay Restorations in Posterior Teeth, Clinical Performance of Cervical-margin-relocated Onlay Restorations. Basic parameters: 20 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Other Machinable 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. - Other Pressed 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. - Other Machinable 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.
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Dentistry, Mansoura University — Al Mansurah
Identifiers
NCT: NCT07157410 · A0502025CD