Clinical Evaluation of Indirect Tooth-Colored Onlays With Cervical Margin Relocation

NCT ID: NCT07157410

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-14

Study Completion Date

2027-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Indirect Tooth-colored Onlay Restorations in Posterior Teeth Clinical Performance of Cervical-margin-relocated Onlay Restorations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Split-mouth randomized allocation at the tooth level (each participant receives three onlays, one per material).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Machinable lithium-disilicate ceramic onlay (IPS e.max CAD)

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Pressed lithium-disilicate ceramic onlay (IPS e.max Press)

Intervention Type OTHER

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.

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.

Group Type EXPERIMENTAL

Machinable composite onlay (BRILLIANT Crios)

Intervention Type OTHER

Single indirect onlay restoration milled from a BRILLIANT Crios block and then adhesively luted on a randomized molar under rubber-dam isolation.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Ihsan AlQurashi

Role: CONTACT

+9647813003774

Facility Contacts

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Ali Ihsan AlQurashi

Role: primary

+9647813003774

Other Identifiers

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A0502025CD

Identifier Type: -

Identifier Source: org_study_id

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