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NCT03039985 Clinical Trial

All-ceramic Crowns in Patients With Sleep Bruxism

Sleep Bruxism Clinical Trial

Official title:
All-ceramic Crowns in Patients With Sleep Bruxism - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03039985
Other study ID # SCHM2456/4-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date November 2, 2022

Study information
Verified date May 2023
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate the complication rate of 2 types of all-ceramic crowns in patients with or without bruxism.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date November 2, 2022
Est. primary completion date November 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - need a molar crown - tooth antagonist (no implant) Exclusion Criteria: - no Antagonist pregnancy, bleeding, periodontal diseases

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Zirconia crowns (Prettau®)
Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism
• lithium disilicate crowns (IPSe.max®)
lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism

Locations
Country Name City State
Germany Department of Prosthodontics, University of Heidelberg Heidelberg

Sponsors (2)
Lead Sponsor Collaborator
Heidelberg University German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Success of all-ceramic crowns as determined by complication rate In this study, a complication is defined as any event happening at the study crown or the supporting tooth that requires a clinical intervention. up to 5 years
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