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

Mansoura University

Status: Enrolling

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

Treatments: Other: Pressed lithium-disilicate ceramic onlay (IPS e.max Press); Other: Machinable lithium-disilicate ceramic onlay (IPS e.max CAD); Other: Machinable composite onlay (BRILLIANT Crios)

Study type: Interventional

Funder types: Other

Identifiers

NCT07157410

A0502025CD

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

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

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

Experimental group

Description:

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.

Treatment:

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

Machinable composite onlay (BRILLIANT Crios)

Experimental group

Description:

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.

Treatment:

Other: Machinable composite onlay (BRILLIANT Crios)