All-ceramic Crowns in Patients With Sleep Bruxism

May 15, 2023 updated by: Brigitte Ohlmann, Heidelberg University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69120
        • Department of Prosthodontics, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no Antagonist pregnancy, bleeding, periodontal diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Collaborators

German Research Foundation

Investigators

  • Principal Investigator: Brigitte Ohlmann, Prof. Dr., Heidelberg University
  • Principal Investigator: Marc Schmitter, Prof. Dr., University of Würzburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 2, 2022

Study Completion (Actual)

November 2, 2022

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 31, 2017

First Posted (Estimate)

February 1, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHM2456/4-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Bruxism

Clinical Trials on lithium disilicate crowns (IPSe.max®)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe