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Completed

NCT Number: NCT07259265

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

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Geneva

Geneva, Canton of Geneva, 1204, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crown preparation

Procedure

The conventional crown preparation will be performed.

Onlay preparation

Procedure

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

Primary outcomes

  1. Restoration survival

    Time frame: 5 years

    Survival of the inserted restorations

Secondary outcomes

  1. Fractures of the restorations.

    Time frame: 5 years

    Any chipping (uncritical fractures) or critical fractures will be assessed.

  2. Tooth vitality

    Time frame: 5 years

    The presence or absence of tooth vitality will be assessed by means of vitality test using cold spray.

  3. Biological outcome - presence of secondary caries

    Time frame: 5 years

    Biological outcome - presence of secondary caries - of the treated teeth using magnification loops, a dental probe and radiographs.

  4. Biological outcome - Bleeding on Probing

    Time frame: 5 years

    Bleeding on probing measures of the treated tooth using a periodontal probe.

  5. Biological outcome - Plaque index

    Time frame: 5 years

    Assessment of the Plaque index of the treated tooth using a dental probe.

  6. Biological outcome - tooth fractures

    Time frame: 5 years

    Assessment of tooth /root fractures using a dental probe and magnification loops.

  7. Biological outcome - pocket probing depth

    Time frame: 5 years

    The pocket probing depth will be assessed in millimeters with a periodontal probe with 1mm distances.

Other outcomes

  1. Restoration wear

    Time frame: 5 years

    Wear of the restorations by measuring the surface changes of the restorations over time. This is analyzed by means of digital intraoral scanning at different time points and measured in micrometers.

Sponsors and collaborators

Lead sponsor

Dr. med. dent. Malin Strasding

Other

Collaborators

  • Institut Straumann AG
  • Ivoclar Vivadent AG

Registry information

Official study title

Longterm Outcomes of Vital and Non-vital Posterior Teeth Restored With Onlays and Single Crowns: a Randomized, Controlled, Clinical Trial

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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