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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07259265

Enrollment

120

Registered

2025-12-02

Start date

2019-03-04

Completion date

2024-02-06

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decayed Teeth

Keywords

onlay, crown, partial coverage, full coverage, ceramic restoration

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).

Interventions

PROCEDURECrown preparation

The conventional crown preparation will be performed.

PROCEDUREOnlay preparation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Restoration survival	5 years	Survival of the inserted restorations

Secondary

Measure	Time frame	Description
Fractures of the restorations.	5 years	Any chipping (uncritical fractures) or critical fractures will be assessed.
Tooth vitality	5 years	The presence or absence of tooth vitality will be assessed by means of vitality test using cold spray.
Biological outcome - presence of secondary caries	5 years	Biological outcome - presence of secondary caries - of the treated teeth using magnification loops, a dental probe and radiographs.
Biological outcome - Plaque index	5 years	Assessment of the Plaque index of the treated tooth using a dental probe.
Biological outcome - tooth fractures	5 years	Assessment of tooth /root fractures using a dental probe and magnification loops.
Biological outcome - pocket probing depth	5 years	The pocket probing depth will be assessed in millimeters with a periodontal probe with 1mm distances.
Biological outcome - Bleeding on Probing	5 years	Bleeding on probing measures of the treated tooth using a periodontal probe.

Other

Measure	Time frame	Description
Restoration wear	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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026