- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06053723
Bruxism and Severity of Temporomandibular Dsyfunction
September 28, 2023 updated by: Hazel Çelik Güzel, Bandırma Onyedi Eylül University
The Effect of Bruxism on Masticatory Functionality and Severity of Temporomandibular Dsyfunction: A Cross-sectional Study
The aim of the study was to investigate the effect of bruxism on Temporomanbular joint functionality and dysfunction severity in individuals with Temporomandibular Dysfunction (TMD).
Study Overview
Status
Completed
Conditions
Detailed Description
The study included 91 individuals aged 20-55 years with TMD.
Participants who volunteered to participate in the study signed the Informed Consent Form and completed the Descriptive Data Form including demographic characteristics.
The presence of bruxism in individuals with TMD was questioned and the maximum mouth opening measurement was recorded.
TMD severity was assessed by Fonseca's Anamnestic Questionnaire (FAQ), pain severity was assessed by Numeric Pain Scale (NPS), and masticatory and TMJ functioning was assessed by JAW Functional Limitation Scale-20 (JFLS-20).
The evaluations of the participants were performed only once.
Study Type
Observational
Enrollment (Actual)
91
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
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Balıkesir, Turkey
- Bandirma Onyedi Eylül University
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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
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
diagnosed with TMD
Description
Inclusion Criteria:
- Aged between 20 and 55 years,
- Diagnosed with TMD,
- volunteer to participate in the study
Exclusion Criteria:
- having a non-reduced disc problem,
- surgical operation due to spine, abdomen and/or TMJ problem,
- trauma, cancer, neurological problems, congenital anomalies, musculoskeletal system problems,
- systemic disease,
- facial paralysis
- Less than 6 months of receiving any treatment related to the spine and TMJ
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 |
|---|---|---|
|
Bruxism evaluation
Time Frame: April 2023- September 2023
|
Sleep bruxism reported by the individual was recorded.
As clinical diagnostic criteria for bruxism; the presence of regular or frequent teeth clenching and grinding sounds followed by pain or fatigue in the jaw muscles on waking up in the morning, temporal headache, masseter muscle hypertrophy, abnormal tooth abrasion and/or jaw locking were questioned and the presence of one or more clinical findings was recorded as bruxism.
|
April 2023- September 2023
|
|
Maximum mouth opening
Time Frame: April 2023- September 2023
|
Maximum pain-free mouth opening was measured with a 15 cm ruler
|
April 2023- September 2023
|
|
Severity of Temporomandibular dysfunction
Time Frame: April 2023- September 2023
|
Fonseca's Anamnestic Questionnaire (FAQ) was used.
The questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress.
As a result of the questionnaire, the presence of TMD is accepted in patients with a score of 25 and above, and the severity can be classified as mild TMJ disorder (25-45), moderate TMJ disorder (50-65) and severe TMJ disorder (70-100).
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April 2023- September 2023
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|
Pain intensity
Time Frame: April 2023- September 2023
|
Numeric Pain Scale (NAS): It is a simple, reliable and short-term method commonly used in the clinic to measure pain intensity.
The patient is told that the most severe pain he/she feels in the TMJ region is 10, and if there is no pain, the pain intensity is 0. The participant was asked to say a number between 0 and 10 corresponding to the intensity of pain felt in the TMJ region.
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April 2023- September 2023
|
|
Jaw Functionality
Time Frame: April 2023- September 2023
|
Jaw Functionality Limitation Scale-20 was used.
It includes a total of 20 items, with "0" indicating no limitation and "10" indicating severe limitation in each item, about the function of the TMJ during different activities, difficulty in chewing and jaw limitation.
As a result of the questionnaire, it was reported that TMJ function was limited in individuals with a score of 5 and above.
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April 2023- September 2023
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
April 15, 2023
Primary Completion (Actual)
September 1, 2023
Study Completion (Actual)
September 15, 2023
Study Registration Dates
First Submitted
September 19, 2023
First Submitted That Met QC Criteria
September 19, 2023
First Posted (Actual)
September 26, 2023
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 28, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-54
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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