NCT03039985

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 1, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2022

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

7.8 years

First QC Date

January 13, 2017

Last Update Submit

May 15, 2023

Conditions

Sleep BruxismMonolithic Ceramic Fixed Dental Prosthesis (Single Crowns)

Outcome Measures

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.

    up to 5 years

Study Arms (4)

Bruxism + lithium disilicate crown

EXPERIMENTAL

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

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.

Device: lithium disilicate crowns (IPSe.max®)

Bruxism + zirconia crown

EXPERIMENTAL

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

Device: Zirconia crowns (Prettau®)

No bruxism + zirconia crown

EXPERIMENTAL

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

Device: Zirconia crowns (Prettau®)

Interventions

Zirconia crowns (Prettau®)DEVICE

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

Bruxism + zirconia crownNo bruxism + zirconia crown
lithium disilicate crowns (IPSe.max®)DEVICE

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

Bruxism + lithium disilicate crownNo bruxism + lithium disilicate crown

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • no Antagonist pregnancy, bleeding, periodontal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Prosthodontics, University of Heidelberg

Heidelberg, 69120, Germany

Location

Related Publications (3)

  • 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.

    PMID: 35348247DERIVED

  • 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.

    PMID: 34862565DERIVED

  • 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.

    PMID: 29777735DERIVED

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

BruxismTooth DiseasesStomatognathic DiseasesParasomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Brigitte Ohlmann, Prof. Dr.

    Heidelberg University

    PRINCIPAL INVESTIGATOR

  • Marc Schmitter, Prof. Dr.

    University of Würzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.dent.

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 1, 2017

Study Start

February 1, 2015

Primary Completion

November 2, 2022

Study Completion

November 2, 2022

Last Updated

May 16, 2023

Record last verified: 2023-05

Locations

DE(1)