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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Mansoura University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- FDI criteria score-functional (F1 Fracture/Retention; F2 Marginal Adaptation), biological (B1-B3), and miscellaneous (M2) domains.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •Teeth act as abutment for fixed or removable prosthesis.
- •Occlusion of fewer than 20 teeth
Arms & Interventions
Machinable lithium-disilicate ceramic onlay (IPS e.max CAD)
Each participant contributes one randomized molar restored with a machinable lithium-disilicate onlay (IPS e.max CAD). Adhesive luting is performed under rubber-dam isolation using the standardized protocol.
Intervention: Machinable lithium-disilicate ceramic onlay (IPS e.max CAD) (Other)
Pressed lithium-disilicate ceramic onlay (IPS e.max Press)
Each participant contributes one randomized molar restored with a pressed lithium-disilicate onlay (IPS e.max Press). Adhesive luting is performed under rubber-dam isolation using the standardized protocol.
Intervention: Pressed lithium-disilicate ceramic onlay (IPS e.max Press) (Other)
Machinable composite onlay (BRILLIANT Crios)
Each participant contributes one randomized molar restored with a machinable composite onlay (BRILLIANT Crios). Adhesive luting is performed under rubber-dam isolation using the standardized protocol.
Intervention: Machinable composite onlay (BRILLIANT Crios) (Other)
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported