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Trial record 55 of 119 for:    ZIRCONIUM

All-ceramic Crowns in Patients With Sleep Bruxism

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ClinicalTrials.gov Identifier: NCT03039985
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Brigitte Ohlmann, Heidelberg University

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.

Condition or disease Intervention/treatment Phase
Sleep Bruxism Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns) Device: Zirconia crowns (Prettau®) Device: lithium disilicate crowns (IPSe.max®) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: All-ceramic Crowns in Patients With Sleep Bruxism - a Randomized Clinical Trial
Study Start Date : February 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bruxism + lithium disilicate crown
Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
Device: lithium disilicate crowns (IPSe.max®)
lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism

Experimental: No bruxism + lithium disilicate crown
Participant without sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.
Device: lithium disilicate crowns (IPSe.max®)
lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism

Experimental: Bruxism + zirconia crown
Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia.
Device: Zirconia crowns (Prettau®)
Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism

Experimental: No bruxism + zirconia crown
Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia.
Device: Zirconia crowns (Prettau®)
Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism




Primary Outcome Measures :
  1. Success of all-ceramic crowns as determined by complication rate [ Time Frame: up to 5 years ]
    In this study, a complication is defined as any event happening at the study crown or the supporting tooth that requires a clinical intervention.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • need a molar crown
  • tooth antagonist (no implant)

Exclusion Criteria:

  • no Antagonist pregnancy, bleeding, periodontal diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039985


Contacts
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Contact: Wolfgang Bömicke, Dr. , MSc Wolfgang.Boemicke@med.uni-heidelberg.de

Locations
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Germany
Department of Prosthodontics, University of Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Brigitte Ohlmann, Prof. Dr.       Brigitte_Ohlmann@med.uni-heidelberg.de   
Principal Investigator: Brigitte Ohlmann, Prof. Dr.         
Sponsors and Collaborators
Heidelberg University
German Research Foundation
Investigators
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Principal Investigator: Brigitte Ohlmann, Prof. Dr. Heidelberg University
Principal Investigator: Marc Schmitter, Prof. Dr. University of Würzburg

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brigitte Ohlmann, Prof. Dr. med.dent., Heidelberg University
ClinicalTrials.gov Identifier: NCT03039985     History of Changes
Other Study ID Numbers: SCHM2456/4-1
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Tooth Diseases
Stomatognathic Diseases
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Lithium Carbonate
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs