Vital and Non-vital Posterior Teeth Restored With Onlays and Single Crowns Using Three Different Restorative Materials.

NCT ID: NCT07259265

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2024-02-06

Brief Summary

The objective of this study is to assess the survival rate and the biological and technical outcomes of onlays and single crowns made out of different restorative materials on vital and non-vital teeth. The onlays are made either out of a lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or out of a lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann). The crowns are made either out of lithium aluminosilicate glass ceramic reinforced with lithium disilicate (N!ce, Straumann), hybrid ceramic (VITA ENAMIC, VITA Zahnfabrik) or lithium-disilicate glass ceramic (E.max CAD, Ivoclar Vivadent).

Conditions

Decayed Teeth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Crown restoration

The tooth is restored with a conventional, full-coverage crown.

Group Type: ACTIVE_COMPARATOR

Crown preparation

Intervention Type: PROCEDURE

The conventional crown preparation will be performed.

Onlay restoration

The tooth is restored with a defect-oriented onlay.

Group Type: EXPERIMENTAL

Onlay preparation

Intervention Type: PROCEDURE

A defect-oriented tooth preparation is performed for an onlay restoration.

Interventions

Crown preparation

The conventional crown preparation will be performed.

Intervention Type: PROCEDURE

Onlay preparation

A defect-oriented tooth preparation is performed for an onlay restoration.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• • Subjects with the need for a fixed reconstruction in premolar and molar region with indication for either crown or onlay.

• min. 18 years of age and ≤ 80 years
• Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5)
• Capable of providing written informed consent
• Absence of any active periodontal and pulpal disease

Exclusion Criteria

• Presence of conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids e.g. history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.
• Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, Hepatitis
• History of neoplastic disease requiring the use of radiation or chemotherapy
• Inability to perform adequate oral hygiene
• Significant reduced saliva flow rate
• Unable or unwilling to cooperate for the trial period
• Allergy to any components of the reconstruction materials and cements
• Alcohol or drug abuse
• Pregnant or lactating women

Specific criteria:

• Root caries / root canal caries
• Extreme short dental arch (eSDA)
• Severe bruxism or clenching habits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Straumann AG

INDUSTRY

Sponsor Role: collaborator

Ivoclar Vivadent AG

INDUSTRY

Sponsor Role: collaborator

Dr. med. dent. Malin Strasding

OTHER

Sponsor Role: lead

Responsible Party

Dr. med. dent. Malin Strasding

PD Dr med dent

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Geneva

Geneva, Canton of Geneva, Switzerland

Countries

Switzerland

Other Identifiers

GTC Study

Identifier Type: -

Identifier Source: org_study_id