Tooth WearNCT04059432
CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?
An observational study of Tooth Wear and Musculoskeletal Disorder, run by University of Liege at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Wear, Musculoskeletal Disorder
- What is being tested?
- Tooth Wear and Musculoskeletal Disorders evaluation
- How many people
- 385 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 30 Oct 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sandrine Bekaert contact
Belgium1 site, 1 recruiting
- Recruiting
Institute of Dentistry University of Liege
Liège, Choose A State, 4020
Amélie Mainjot, +32 496 95 30 30, a.mainjot@chuliege.be
About this study
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.
Read the detailed description
This study is based on questionnaires and clinical examination performed by a dentist.
- Conditions
- Tooth Wear, Musculoskeletal Disorder
- Being tested
- Tooth Wear and Musculoskeletal Disorders evaluation
- Keywords
- Tooth Wear, Musculoskeletal Disorders
- Medical subject headings
- Tooth Wear, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth Wear and Musculoskeletal Disorders evaluationDiagnostic test
Evaluation of dental wear by BEWE (Basic Erosive Wear Examination: score 0-3) examination and Musculoskeletal disorders are listed by the "NORDIC" questionnaire developed by Kuorinka et al. (2001)
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of musculoskeletal disorders (MSDs)
"Nordique Questionnaire": validated self-report questionnaire to evaluate musculo skeletal health, particularly MSD on 9 different zones
Measured: through study completion, an average of 1 year
Tooth wear following BEWE index
Clinical examination will give a global score on 18 following Basic Erosive Wear Examination (BEWE) index.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Life habits and stress
10-points likert scale self-report questionnaire
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start1 Mar 2019
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth WearStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 385 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mainjot Amélie, University of Liege
- Investigators
- Amélie Mainjot, Study director, CHU-ULg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059432
- Sponsor's protocol ID
- CH001
- Status last verified
- Aug 2019
- First submitted
- 9 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Include some patients in a second study to be developed
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHAIN1 : Dental Wear and Musculoskeletal Disorders - Association?
- ClinicalTrials.gov ID
- NCT04059432
- Acronym / sponsor ID
- CH001
- Conditions
- Tooth Wear, Musculoskeletal Disorder
- Keywords
- Tooth Wear, Musculoskeletal Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 385 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 16 Aug 2019 (actual)
- 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.
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.
Detailed description
This study is based on questionnaires and clinical examination performed by a dentist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Tooth Wear and Musculoskeletal Disorders evaluationEvaluation of dental wear by BEWE (Basic Erosive Wear Examination: score 0-3) examination and Musculoskeletal disorders are listed by the "NORDIC" questionnaire developed by Kuorinka et al. (2001) | Diagnostic test | – |
Primary outcome
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
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.
1 secondary outcome
Life habits and stress
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: Yes. Include some patients in a second study to be developed
Related trials for Tooth Wear
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Evaluation of Wear Resistance of CAD/CAM Hybrid Ceramic and Nano-Hybrid Composite Overlays in Endodontically Treated Molars and Their Effect on Natural Antagonist Teeth
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PRINTOW: Occlusal Wear of Denture Teeth in Digitally Fabricated Complete Dentures
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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.
Sandrine Bekaert contact
Amélie Mainjot study director
CHU-ULg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Wear and Musculoskeletal Disorder, run by University of Liege at 1 site in Belgium.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Aug 2019. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amélie Mainjot, DDS, MSc, PhD (+32 496 95 30 30, a.mainjot@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of musculoskeletal disorders (MSDs) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2019.