Monolithic zirconia crowns – a prospective randomized controlled clinical trial and monolithic zirconia partial crowns - a prospective clinical trial

Not Applicable

• Conditions: severe wear of teeth to be restored; K02.1; K02.2; K02.3; K02.4; K02.5; K02.8; K02.9; Caries of dentine; Caries of cementum

• Registration Number: DRKS00013257
• Lead Sponsor: niklinik RWTH Aachen Klinik für Zahnärztliche Prothetik und Biomaterialien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. Due to the fact that the preparations for the study crowns are not different from other crown indications already prepared teeth can be included.
2. The participants of the study must be adult and growth must be completed. Written informed consent must be available.
3. Indication for posterior crown(s) or partial crown.
4. Natural teeth or fixed partial dentures / fixed restorations as antagonists.
5. High probability that the antagonist material stays in situ for at least three years.
6. Within in the study a maximum of two crowns (one zirconia and one lithiumdisilicate) and at least one partial crown made of zirconia can be inserted.
7. No general dental complaints
8. No periodontal treatment needs. Absence of periodontal diseases are characterized by: pocket depths > 3mm, affection of furcation, tooth loosening. Does a patient not fulfill the requirements the monitor or the quality assurance makes a decision if the patient can be included after certain pretreatments.
9. Sufficient oral hygiene: Threshold is the Sulcus Bleeding Index (SBI) of 70%.
10. Within the first four years there should not be the need of comprehensive treatments beside the study teeth.
11. The patient should be able to attend probably the recall appointments.

Exclusion Criteria

1. Patients exhibiting signs of TMDs (temporo mandibular disorders) including pathological signs in static and dynamic occlusion.
2. Teeth with pathological signs (sensitivity, periodontal status).
3. Insufficient oral hygiene.
4. Adverse general health conditions.
5. Pregnancy and breast-feeding patients
6. Bruxism is no contra-indication.
7. Minors
8. Consent inability.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival rate of the monolithic restoratiions in comparison with existing standard restorations

Secondary Outcome Measures

Name	Time	Method
a) The marginal fit of the lithiumdisilicate and zironia <br>crowns do not differ more than 50 µm exhibiting a standarddviation more than 40 µm.<br>b) The marginal fit of the partial crowns does not differ in the same range compared to the monolithic crowns.<br>c) The antagonist wear caused by the restorations does not differ dependent from the material used within the study.<br>d) The lithium disilicate crowns and the monolithic zirconia crowns do not differ significantly with respect to shape and esthetics.<br>e) Evaluation of the temporary cement with respect to retention and sensitivity.