Temporomandibular DysfunctionNCT06053723
Bruxism and Severity of Temporomandibular Dsyfunction
An observational study of Temporomandibular Dysfunction, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Temporomandibular Dysfunction
- What is being tested?
- Fonseca's Anamnestic Questionnaire, Numeric Pain Scale and Jaw Functionality Limitation Scale-20
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Sep 2023
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: diagnosed with TMD
Who may be able to join
- Aged between 20 and 55 years,
- Diagnosed with TMD,
- volunteer to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Temporomandibular Dysfunction
- Being tested
- Fonseca's Anamnestic Questionnaire, Numeric Pain Scale, Jaw Functionality Limitation Scale-20
- Keywords
- temporomandibular dysfunction, bruxism, chewing functionality
- Medical subject headings
- Temporomandibular Joint Disorders, Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fonseca's Anamnestic QuestionnaireOther
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.
Numeric Pain ScaleOther
It is a simple, reliable and short-term method that is frequently used to measure pain intensity in the clinic.
Jaw Functionality Limitation Scale-20Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruxism evaluation
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.
Measured: April 2023- September 2023
Maximum mouth opening
Maximum pain-free mouth opening was measured with a 15 cm ruler
Measured: April 2023- September 2023
Severity of Temporomandibular dysfunction
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).
Measured: April 2023- September 2023
Pain intensity
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.
Measured: April 2023- September 2023
Jaw Functionality
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.
Measured: April 2023- September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start15 Apr 2023
- Primary completion1 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DysfunctionStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandırma Onyedi Eylül University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazel Çelik Güzel, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06053723
- Sponsor's protocol ID
- 2023-54
- Status last verified
- Sep 2023
- First submitted
- 19 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bruxism on Masticatory Functionality and Severity of Temporomandibular Dsyfunction: A Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06053723
- Acronym / sponsor ID
- 2023-54
- Conditions
- Temporomandibular Dysfunction
- Keywords
- temporomandibular dysfunction, bruxism, chewing functionality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Bandırma Onyedi Eylül UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 26 Sep 2023 (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.
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).
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- diagnosed with TMD
Key inclusion criteria (3 listed)
- Aged between 20 and 55 years,
- Diagnosed with TMD,
- volunteer to participate in the study
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Fonseca's Anamnestic QuestionnaireThe questionnaire includes 10 questions about joint, head and neck pain, pain during masticatory activity, parafunctional habits, decreased joint motion, impaired occlusion and emotional stress. | Other | – |
| Numeric Pain ScaleIt is a simple, reliable and short-term method that is frequently used to measure pain intensity in the clinic. | Other | – |
| Jaw Functionality Limitation Scale-20It 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. | Other | – |
Primary outcome
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.
Maximum mouth opening
Time frame: April 2023- September 2023
Maximum pain-free mouth opening was measured with a 15 cm ruler
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Temporomandibular Dysfunction, run by Bandırma Onyedi Eylül University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 29 Sep 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruxism evaluation (time frame: April 2023- September 2023). The study lists 5 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 29 Sep 2023.