Sleep BruxismNCT03039985
All-ceramic Crowns in Patients With Sleep Bruxism
A study testing Zirconia crowns (Prettau®) and lithium disilicate crowns (IPSe.max®) in people with Sleep Bruxism and Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns), run by Heidelberg University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Bruxism, Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns)
- What is being tested?
- Zirconia crowns (Prettau®) and lithium disilicate crowns (IPSe.max®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2015to 2 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- need a molar crown
- tooth antagonist (no implant)
Who cannot join
- no Antagonist pregnancy, bleeding, periodontal diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Prosthodontics, University of Heidelberg
Heidelberg, 69120
About this study
Official title: 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.
- Being tested
- Zirconia crowns (Prettau®), lithium disilicate crowns (IPSe.max®)
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia crowns (Prettau®)Device
Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism
lithium disilicate crowns (IPSe.max®)Device
lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism
| Study group | Role | What they receive |
|---|---|---|
| Bruxism + lithium disilicate crown | Experimental | Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate. Receives: Device: lithium disilicate crowns (IPSe.max®) |
| No bruxism + lithium disilicate crown | Experimental | Participant without sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate. Receives: Device: lithium disilicate crowns (IPSe.max®) |
| Bruxism + zirconia crown | Experimental | Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia. Receives: Device: Zirconia crowns (Prettau®) |
| No bruxism + zirconia crown | Experimental | Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia. Receives: Device: Zirconia crowns (Prettau®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startFeb 2015
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Brigitte Ohlmann, Heidelberg University
- Investigators
- Brigitte Ohlmann, Prof. Dr., Principal investigator, Heidelberg UniversityMarc Schmitter, Prof. Dr., Principal investigator, University of Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039985
- Sponsor's protocol ID
- SCHM2456/4-1
- Status last verified
- May 2023
- First submitted
- 13 Jan 2017
- Last updated
- 16 May 2023
- Results posted
- No
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 41967567Ohlmann 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 35348247Ohlmann 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 34862565Ohlmann 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
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- All-ceramic Crowns in Patients With Sleep Bruxism - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03039985
- Acronym / sponsor ID
- SCHM2456/4-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- Feb 2015
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Bruxism + lithium disilicate crown | Experimental | Device: lithium disilicate crowns (IPSe.max®)Participant with sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate. |
| No bruxism + lithium disilicate crown | Experimental | Device: lithium disilicate crowns (IPSe.max®)Participant without sleep bruxism receives a monolithic molar crown manufactured from lithium disilicate. |
| Bruxism + zirconia crown | Experimental | Device: Zirconia crowns (Prettau®)Participant with sleep bruxism receives a monolithic molar crown manufactured from zirconia. |
| No bruxism + zirconia crown | Experimental | Device: Zirconia crowns (Prettau®)Participant without sleep bruxism receives a monolithic molar crown manufactured from zirconia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- need a molar crown
- tooth antagonist (no implant)
Key exclusion criteria (1 listed)
- no Antagonist pregnancy, bleeding, periodontal diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia crowns (Prettau®)Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism | Device | Bruxism + zirconia crown, No bruxism + zirconia crown |
| lithium disilicate crowns (IPSe.max®)lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism | Device | Bruxism + lithium disilicate crown, No bruxism + lithium disilicate crown |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Derived from this study: PubMed 41967567Bomicke 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.
- Derived from this study: PubMed 35348247Ohlmann 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.
- Derived from this study: PubMed 34862565Ohlmann 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.
- Derived from this study: PubMed 29777735Ohlmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Ohlmann, Prof. Dr. principal investigator
Heidelberg University
Marc Schmitter, Prof. Dr. principal investigator
University of Würzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia crowns (Prettau®) and lithium disilicate crowns (IPSe.max®) in people with Sleep Bruxism and Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns), run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of all-ceramic crowns as determined by complication rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03039985, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2023.