- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04059432
CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?
August 19, 2019 updated by: Mainjot Amélie, University of Liege
This study aims to explore the relationships between tooth wear (TW) and musculoskeletal disorders (MSDs).
The null hypothesis is that TW is not associated to MSDs.
It also explores the influence of bruxism signs, life habits and stress on TW and MSDs.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study is based on questionnaires and clinical examination performed by a dentist.
Study Type
Observational
Enrollment (Anticipated)
385
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
-
-
Choose A State
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Liege, Choose A State, Belgium, 4020
- Recruiting
- Institute of Dentistry University of Liege
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Contact:
- Amélie Mainjot
- Phone Number: +32 496 95 30 30
- Email: a.mainjot@chuliege.be
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-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients consulting in the Fixed Prosthesis Department (Dentistry Department) at the Polyclinic Lucien Brull from Liège University Hospital between March 2019 and October 2019
Description
Inclusion Criteria:
- Between 18 and 80 years old
- Have the mental abilities to participate in study
- Understand the language of the survey (French)
- Sign free and informed consent
Exclusion Criteria:
- Consult for a painful dental emergency
- Do not have at least 8 teeth per maxilla, with natural dental tissues in contact with the antagonistic teeth
- Being in the process of an orthodontic treatment
- Wear of a bimaxillary orthognathic nightguard
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Presence of musculoskeletal disorders (MSDs)
Time Frame: through study completion, an average of 1 year
|
"Nordique Questionnaire": validated self-report questionnaire to evaluate musculo skeletal health, particularly MSD on 9 different zones
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through study completion, an average of 1 year
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|
Tooth wear following BEWE index
Time Frame: through study completion, an average of 1 year
|
Clinical examination will give a global score on 18 following Basic Erosive Wear Examination (BEWE) index.
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Life habits and stress
Time Frame: through study completion, an average of 1 year
|
10-points likert scale self-report questionnaire
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amélie Mainjot, CHU-ULg
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 (Actual)
March 1, 2019
Primary Completion (Anticipated)
October 30, 2019
Study Completion (Anticipated)
October 30, 2019
Study Registration Dates
First Submitted
August 9, 2019
First Submitted That Met QC Criteria
August 15, 2019
First Posted (Actual)
August 16, 2019
Study Record Updates
Last Update Posted (Actual)
August 21, 2019
Last Update Submitted That Met QC Criteria
August 19, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Include some patients in a second study to be developed
IPD Sharing Supporting Information Type
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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