Temporomandibular Joint Dysfunction SyndromeNCT05802953
Quality of Life in Temporomandibular Joint Dysfunction
An observational study of Temporomandibular Joint Dysfunction Syndrome, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
It is planned to examine the relationship between quality of life in patients with temporomandibular joint dysfunction and the patient's individual, physical and psychosocial characteristics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Physical assessments and Questionnaire
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2022to 25 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be conducted in Afyonkarahisar Health Science University Faculty of Dentistry. 18-85 aged patients with TMD will be included.
Who may be able to join
- Being between the ages of 18-65,
- Being in group I according to RDC/TMD Axis I,
Who cannot join
- Any treatment for temporomandibular joint dysfunction (TMD) in the last six months
- Having dental problems
- Having any disorder and/or disease involving structures and/or masticatory muscles associated with TMD
- Having a history of trauma in the head and neck region,
- Having previously undergone temporomandibular joint surgery,
- Using corticosteroid and anticonvulsant drugs
- Patients who have received physiotherapy and rehabilitation related to the temporomandibular joint in the last six months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Emel Taşvuran Horata
Afyonkarahisar, 03030
EMEL TAŞVURAN HORATA, PhD, 05547759663, ethorata@gmail.com
Emel TAŞVURAN HORATA
About this study
Official title: Investigation of the Relationship of Individual, Physical and Psychosocial Characteristics With Quality of Life in Temporomandibular Joint Dysfunction
It is planned to examine the relationship between quality of life in patients with temporomandibular joint dysfunction and the patient's individual, physical and psychosocial characteristics.
Read the detailed description
A recent study showed that individuals with TMD have a lower quality of life than healthy controls. In addition, it was determined in the study that investigating the quality of life is insufficient. Future studies should search for psychosocial aspects related to TMD. The aim of this study is to individual the physical and psychosocial characteristics of individuals with Axis I TMD and examine their relationship with quality of life.
- Being tested
- Physical assessments, Questionnaire
- Keywords
- Temporomandibular Joint Dysfunction Syndrome, Quality of Life
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical assessmentsOther
Physical assessments include the presence of joint sounds (yes/no), Fonseca Anamnestic Questionnaire, tenderness/pressure pain threshold rating, muscle strengths assessments, temporomandibular joint and cervical region range of motion measurements, and pain.
QuestionnaireOther
General Health Questionnaire-28 and SF-36 will be apply.
| Study group | Role | What they receive |
|---|---|---|
| Temporomandibular joint dysfunction group | The group will include patients with temporomandibular joint dysfunction. Receives: Other: Physical assessments; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life scores
The quality of life will be assess using SF-36. This questionnaire has 8 sections and 36 items. The sections evaluate health between 0-100 and the higher the score indicates the better the quality of life.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start2 Nov 2022
- Primary completion25 Dec 2023
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802953
- Sponsor's protocol ID
- 2022/5
- Status last verified
- Dec 2023
- First submitted
- 26 Mar 2023
- Last updated
- 27 Dec 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Individual, Physical and Psychosocial Characteristics With Quality of Life in Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT05802953
- Acronym / sponsor ID
- 2022/5
- Keywords
- Temporomandibular Joint Dysfunction Syndrome, Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 7 Apr 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.
It is planned to examine the relationship between quality of life in patients with temporomandibular joint dysfunction and the patient's individual, physical and psychosocial characteristics.
Detailed description
A recent study showed that individuals with TMD have a lower quality of life than healthy controls. In addition, it was determined in the study that investigating the quality of life is insufficient. Future studies should search for psychosocial aspects related to TMD. The aim of this study is to individual the physical and psychosocial characteristics of individuals with Axis I TMD and examine their relationship with quality of life.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Temporomandibular joint dysfunction group | – | Other: Physical assessments, Other: QuestionnaireThe group will include patients with temporomandibular joint dysfunction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be conducted in Afyonkarahisar Health Science University Faculty of Dentistry. 18-85 aged patients with TMD will be included.
Key inclusion criteria (2 listed)
- Being between the ages of 18-65,
- Being in group I according to RDC/TMD Axis I,
Key exclusion criteria (7 listed)
- Any treatment for temporomandibular joint dysfunction (TMD) in the last six months
- Having dental problems
- Having any disorder and/or disease involving structures and/or masticatory muscles associated with TMD
- Having a history of trauma in the head and neck region,
- Having previously undergone temporomandibular joint surgery,
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 |
|---|---|---|
| Physical assessmentsPhysical assessments include the presence of joint sounds (yes/no), Fonseca Anamnestic Questionnaire, tenderness/pressure pain threshold rating, muscle strengths assessments, temporomandibular joint and cervical region range of motion measurements, and pain. | Other | Temporomandibular joint dysfunction group |
| QuestionnaireGeneral Health Questionnaire-28 and SF-36 will be apply. | Other | Temporomandibular joint dysfunction group |
Primary outcome
Quality of life scores
Time frame: 10 minutes
The quality of life will be assess using SF-36. This questionnaire has 8 sections and 36 items. The sections evaluate health between 0-100 and the higher the score indicates the better the quality of life.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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.
EMEL TAŞVURAN HORATA, PhD principal investigator
Afyonkarahisar Health Sciences University
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 Joint Dysfunction Syndrome, run by Afyonkarahisar Health Sciences 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 2 inclusion and 7 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 27 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EMEL TAŞVURAN HORATA, PhD (+905547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life scores (time frame: 10 minutes). 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 27 Dec 2023.