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

NCT07259265 | Completed

• 1 other identifier: GTC Study
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

onlay; crown; partial coverage; full coverage; ceramic restoration

Outcome Measures

Primary Outcomes (1)

• Restoration survival

  Survival of the inserted restorations

  5 years

Secondary Outcomes (7)

• Fractures of the restorations.

  5 years

• Tooth vitality

  5 years

• Biological outcome - presence of secondary caries

  5 years

• Biological outcome - Bleeding on Probing

  5 years

• Biological outcome - Plaque index

  5 years

Other Outcomes (1)

• Restoration wear

  5 years

Study Arms (2)

Crown restoration

ACTIVE COMPARATOR

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

Procedure: Crown preparation

Onlay restoration

EXPERIMENTAL

The tooth is restored with a defect-oriented onlay.

Procedure: Onlay preparation

Interventions

Crown preparation PROCEDURE

The conventional crown preparation will be performed.

Crown restoration

Onlay preparation PROCEDURE

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

Onlay restoration

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. med. dent. Malin Strasding: lead
• Institut Straumann AG: collaborator
• Ivoclar Vivadent AG: collaborator

Study Sites (1)

University of Geneva

Geneva, Canton of Geneva, 1204, Switzerland

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr med dent

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 2, 2025
• Study Start: March 4, 2019
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)