Temporomandibular Disorder (TMD)TMED-CME-PPTNCT07407127
Cervical Muscle Endurance and Pressure Pain Threshold in University Students With TMD: A Case-Control Study
An observational study of Temporomandibular Disorder (TMD) and Pain Threshold, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study aims to compare the static endurance of cervical region muscles, pressure pain thresholds of selected muscles of the stomatognathic system, and postural characteristics in young adults with and without temporomandibular joint dysfunction (TMD). Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder (TMD), Pain Threshold
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 15 Jun 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population consisted of university students aged 18-25 studying at Igdir University Karaagac Campus.
Who may be able to join
- Currently enrolled as a student at Igdır University.
- The inclusion criterion for the TMD group was defined as scoring 15 points or more on the Fonseca Anamnesis Index (FAI), while the criterion for the control group was an FAI score below 15.
Who cannot join
- Underwent surgery in the neck or mandibular regions
- Had a history of intervertebral disk problems, regardless of clinical symptoms
- Experienced mechanical neck pain for ≥3 months
- Had scoliosis
- Had reducible or irreducible displacement of the temporomandibular joint disk
- Had a history of trigeminal neuralgia
- Were undergoing orthodontic dental treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Cervical Muscle Endurance and Pressure Pain Threshold in University Students With Temporomandibular Joint Dysfunction: A Case-Control Study
Aim: This study aims to compare the static endurance of cervical region muscles, pressure pain thresholds of selected muscles of the stomatognathic system, and postural characteristics in young adults with and without temporomandibular joint dysfunction (TMD).
Method: A total of 60 university students aged between 18 and 25 years will be included in the study. Participants will be divided into two groups: individuals with temporomandibular joint dysfunction (TMD group, n=30) and healthy controls (control group, n=30). The static endurance of cervical flexor and extensor muscles will be assessed using standardized endurance tests. Pressure pain thresholds of the temporalis, masseter, sternocleidomastoid, and upper trapezius muscles will be measured using a pressure algometer. Postural characteristics will be evaluated using the New York Posture Analysis (NYPA).
Read the detailed description
The socio-demographic data of the individuals, including age, height, weight, etc., were recorded. The Fonseca Anamnestic Index (FAI) was used to identify the presence of TMD, and individuals with a score above 15 (FAI≥15) were determined to have TMD. Additionally, individuals' muscular endurance was assessed using a standard endurance test, pressure pain thresholds were measured with an algometer, and posture was evaluated using the New York Posture Analysis.
- Conditions
- Temporomandibular Disorder (TMD), Pain Threshold
- Keywords
- Temporomandibular joint dysfunction, cervical muscle endurance, pain threshold, posture
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TMD Group | TMD group was defined as scoring 15 points or more on the Fonseca Anamnesis Index (FAI). | |
| Control Group | Control group was an FAI score below 15. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Muscle Endurance Assessment
Static endurance of cervical flexor and extensor muscles was measured in seconds. Extensors: participants lay prone, lifted the head slightly, and held a 2-kg weight as long as possible. Flexors: participants lay supine, performed slight craniocervical flexion, and maintained the position. Test ended with pain, loss of position, or sufficient endurance. Intra-observer reliability: flexors 0.71-0.93, extensors 0.73-0.85.
Measured: 2 week
Pressure Pain Threshold Assesment
Pressure pain threshold (PPT) was measured using a Baseline Push-Pull Force Gauge® algometer with a 1 cm rubber tip. After familiarization, pressure was applied perpendicularly to the most sensitive points of the upper trapezius, masseter, temporalis, and SCM muscles until participants reported pain. Each site was tested three times with ≥20 s intervals, and the average value was recorded as the PPT.
Measured: 2 week
Secondary outcomes (1)
Posture Assessment
Posture was assessed using the NYPA, evaluating alignment of 13 body regions including head, neck, shoulders, back, waist, hips, and ankles. Each region was scored 1 (severe impairment), 3 (moderate), or 5 (good), giving a total score of 13-65. Scores were categorized as very good (≥45), good (40-44), moderate (30-39), poor (20-29), or bad (≤19). Reliability coefficients range from 0.93 to 0.98.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Apr 2024
- Primary completion15 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BİNNAZ BOZKURT AKPULAT, Kırıkkale University
- Investigators
- Aydan AYTAR, Prof. Dr., Study director, University of Health Sciences, Gülhane Faculty of Physiotherapy and RehabilitationBinnaz Bozkurt Akpulat, MSc., Principal investigator, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407127
- Sponsor's protocol ID
- IGDU-EC-27-03-2024
- Acronym
- TMED-CME-PPT
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and because the data were collected solely for the purposes approved by the ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Cervical Muscle Endurance and Pressure Pain Threshold in University Students With Temporomandibular Joint Dysfunction: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07407127
- Acronym / sponsor ID
- TMED-CME-PPT / IGDU-EC-27-03-2024
- Conditions
- Temporomandibular Disorder (TMD), Pain Threshold
- Keywords
- Temporomandibular joint dysfunction, cervical muscle endurance, pain threshold, posture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 15 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 12 Feb 2026 (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.
Aim: This study aims to compare the static endurance of cervical region muscles, pressure pain thresholds of selected muscles of the stomatognathic system, and postural characteristics in young adults with and without temporomandibular joint dysfunction (TMD).
Method: A total of 60 university students aged between 18 and 25 years will be included in the study. Participants will be divided into two groups: individuals with temporomandibular joint dysfunction (TMD group, n=30) and healthy controls (control group, n=30). The static endurance of cervical flexor and extensor muscles will be assessed using standardized endurance tests. Pressure pain thresholds of the temporalis, masseter, sternocleidomastoid, and upper trapezius muscles will be measured using a pressure algometer. Postural characteristics will be evaluated using the New York Posture Analysis (NYPA).
Detailed description
The socio-demographic data of the individuals, including age, height, weight, etc., were recorded. The Fonseca Anamnestic Index (FAI) was used to identify the presence of TMD, and individuals with a score above 15 (FAI≥15) were determined to have TMD. Additionally, individuals' muscular endurance was assessed using a standard endurance test, pressure pain thresholds were measured with an algometer, and posture was evaluated using the New York Posture Analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMD Group | – | –TMD group was defined as scoring 15 points or more on the Fonseca Anamnesis Index (FAI). |
| Control Group | – | –Control group was an FAI score below 15. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population consisted of university students aged 18-25 studying at Igdir University Karaagac Campus.
Key inclusion criteria (2 listed)
- Currently enrolled as a student at Igdır University.
- The inclusion criterion for the TMD group was defined as scoring 15 points or more on the Fonseca Anamnesis Index (FAI), while the criterion for the control group was an FAI score below 15.
Key exclusion criteria (7 listed)
- Underwent surgery in the neck or mandibular regions
- Had a history of intervertebral disk problems, regardless of clinical symptoms
- Experienced mechanical neck pain for ≥3 months
- Had scoliosis
- Had reducible or irreducible displacement of the temporomandibular joint disk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cervical Muscle Endurance Assessment
Time frame: 2 week
Static endurance of cervical flexor and extensor muscles was measured in seconds. Extensors: participants lay prone, lifted the head slightly, and held a 2-kg weight as long as possible. Flexors: participants lay supine, performed slight craniocervical flexion, and maintained the position. Test ended with pain, loss of position, or sufficient endurance. Intra-observer reliability: flexors 0.71-0.93, extensors 0.73-0.85.
Pressure Pain Threshold Assesment
Time frame: 2 week
Pressure pain threshold (PPT) was measured using a Baseline Push-Pull Force Gauge® algometer with a 1 cm rubber tip. After familiarization, pressure was applied perpendicularly to the most sensitive points of the upper trapezius, masseter, temporalis, and SCM muscles until participants reported pain. Each site was tested three times with ≥20 s intervals, and the average value was recorded as the PPT.
1 secondary outcome
Posture Assessment
Time frame: 2 week
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 12 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and because the data were collected solely for the purposes approved by the ethics committee.
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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.
Aydan AYTAR, Prof. Dr. study director
University of Health Sciences, Gülhane Faculty of Physiotherapy and Rehabilitation
Binnaz Bozkurt Akpulat, MSc. principal investigator
Igdir 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 Disorder (TMD) and Pain Threshold, run by Kırıkkale 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
Cervical Muscle Endurance Assessment (time frame: 2 week). 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 12 Feb 2026.