Back to resultsAll-ceramic Crowns in Patients With Sleep Bruxism
Primary Purpose
Sleep Bruxism, Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns)
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Zirconia crowns (Prettau®)
lithium disilicate crowns (IPSe.max®)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Bruxism
Eligibility Criteria
Inclusion Criteria:
- need a molar crown
- tooth antagonist (no implant)
Exclusion Criteria:
- no Antagonist pregnancy, bleeding, periodontal diseases
Sites / Locations
- Department of Prosthodontics, University of Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Bruxism + lithium disilicate crown
No bruxism + lithium disilicate crown
Bruxism + zirconia crown
No bruxism + zirconia crown
Arm Description
Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
Participant without sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia.
Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03039985
First Posted
January 13, 2017
Last Updated
May 15, 2023
Sponsor
Heidelberg University
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03039985
Brief Title
All-ceramic Crowns in Patients With Sleep Bruxism
Official Title
All-ceramic Crowns in Patients With Sleep Bruxism - a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
German Research Foundation
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Bruxism, Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bruxism + lithium disilicate crown
Arm Type
Experimental
Arm Description
Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
Arm Title
No bruxism + lithium disilicate crown
Arm Type
Experimental
Arm Description
Participant without sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
Arm Title
Bruxism + zirconia crown
Arm Type
Experimental
Arm Description
Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia.
Arm Title
No bruxism + zirconia crown
Arm Type
Experimental
Arm Description
Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia.
Intervention Type
Device
Intervention Name(s)
Zirconia crowns (Prettau®)
Intervention Description
Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism
Intervention Type
Device
Intervention Name(s)
lithium disilicate crowns (IPSe.max®)
Intervention Description
lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism
Primary Outcome Measure Information:
Title
Success of all-ceramic crowns as determined by complication rate
Description
In this study, a complication is defined as any event happening at the study crown or the supporting tooth that requires a clinical intervention.
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
need a molar crown
tooth antagonist (no implant)
Exclusion Criteria:
no Antagonist pregnancy, bleeding, periodontal diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Ohlmann, Prof. Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Schmitter, Prof. Dr.
Organizational Affiliation
University of Würzburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Prosthodontics, University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
35348247
Citation
Ohlmann B, Rathmann F, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Validity of patient self-reports and clinical signs in the assessment of sleep bruxism based on home-recorded electromyographic/electrocardiographic data. J Oral Rehabil. 2022 Jul;49(7):720-728. doi: 10.1111/joor.13327. Epub 2022 Apr 11.
Results Reference
derived
PubMed Identifier
34862565
Citation
Ohlmann B, Bomicke W, Behnisch R, Rammelsberg P, Schmitter M. Variability of sleep bruxism-findings from consecutive nights of monitoring. Clin Oral Investig. 2022 Apr;26(4):3459-3466. doi: 10.1007/s00784-021-04314-8. Epub 2021 Dec 3.
Results Reference
derived
PubMed Identifier
29777735
Citation
Ohlmann B, Bomicke W, Habibi Y, Rammelsberg P, Schmitter M. Are there associations between sleep bruxism, chronic stress, and sleep quality? J Dent. 2018 Jul;74:101-106. doi: 10.1016/j.jdent.2018.05.007. Epub 2018 May 17.
Results Reference
derived
Learn more about this trial
All-ceramic Crowns in Patients With Sleep Bruxism
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