All-ceramic Crowns in Patients With Sleep Bruxism

NCT ID: NCT03039985

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2022-11-02

Brief Summary

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

Detailed Description

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Conditions

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Sleep Bruxism Monolithic Ceramic Fixed Dental Prosthesis (Single Crowns)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bruxism + lithium disilicate crown

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

Group Type EXPERIMENTAL

lithium disilicate crowns (IPSe.max®)

Intervention Type DEVICE

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

No bruxism + lithium disilicate crown

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

Group Type EXPERIMENTAL

lithium disilicate crowns (IPSe.max®)

Intervention Type DEVICE

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

Bruxism + zirconia crown

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

Group Type EXPERIMENTAL

Zirconia crowns (Prettau®)

Intervention Type DEVICE

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

No bruxism + zirconia crown

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

Group Type EXPERIMENTAL

Zirconia crowns (Prettau®)

Intervention Type DEVICE

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

Interventions

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Zirconia crowns (Prettau®)

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

Intervention Type DEVICE

lithium disilicate crowns (IPSe.max®)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* no Antagonist pregnancy, bleeding, periodontal diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Brigitte Ohlmann

Prof. Dr. med.dent.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brigitte Ohlmann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Marc Schmitter, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Würzburg

Locations

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Department of Prosthodontics, University of Heidelberg

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 35348247 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34862565 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29777735 (View on PubMed)

Other Identifiers

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SCHM2456/4-1

Identifier Type: -

Identifier Source: org_study_id

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