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CompletedNCT03039985Updated May 16, 2023

All-ceramic Crowns in Patients With Sleep Bruxism

An interventional study of Zirconia crowns (Prettau®) and lithium disilicate crowns (IPSe.max®) in Sleep Bruxism and Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns), sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Heidelberg University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
109
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Sleep Bruxism
  • Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns)

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03

In context

Sleep Bruxism

63 studies on the registry are indexed under Sleep Bruxism; 10 are open to participants now.

This study's enrollment of 109 is above the median of 40 across 41 interventional studies indexed under Sleep Bruxism.

Browse Sleep Bruxism studies →

Lead sponsor

Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no Antagonist pregnancy, bleeding, periodontal diseases
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
109 participants (actual)

Study arms

  • Experimental
    Bruxism + lithium disilicate crown

    Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate.

    Device: lithium disilicate crowns (IPSe.max®)

  • 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®)

  • Experimental
    Bruxism + zirconia crown

    Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia.

    Device: Zirconia crowns (Prettau®)

  • Experimental
    No bruxism + zirconia crown

    Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia.

    Device: Zirconia crowns (Prettau®)

Interventions

  • DeviceZirconia crowns (Prettau®)

    Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism

  • Devicelithium disilicate crowns (IPSe.max®)

    lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 5 years

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Study locations

1 site
  • Department of Prosthodontics, University of Heidelberg
    Heidelberg, 69120, Germany
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References and documents

Publications

  • Bomicke W, Schmitter M, Waldecker M, Handermann R, Labis C, Rammelsberg P, Ohlmann B. Ceramic crowns and sleep bruxism: 3-year results of a randomized controlled trial. J Dent. 2026 Jul;170:106691. doi: 10.1016/j.jdent.2026.106691. Epub 2026 Apr 10. PubMed 41967567 ↗
  • 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. PubMed 35348247 ↗
  • 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. PubMed 34862565 ↗
  • 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. PubMed 29777735 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03039985
Collaborators
German Research Foundation
Responsible party
Brigitte Ohlmann (Prof. Dr. med.dent., Heidelberg University) — Principal investigator
First posted
Feb 1, 2017
Start date
Feb 2015
Primary completion
Nov 2, 2022
Completion
Nov 2, 2022
Last update
May 16, 2023

Study contacts

Brigitte Ohlmann, Prof. Dr.
principal investigator · Heidelberg University
Marc Schmitter, Prof. Dr.
principal investigator · University of Würzburg
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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