Temporomandibular Joint DisordersPIR-TMDNCT07130279
Post-Isometric Relaxation in Temporomandibular Disorders
A study testing Postural Exercises + Post-Isometric Relaxation (PIR) Technique and Postural Exercises in people with Temporomandibular Joint Disorders and Myofascial Pain Syndromes, run by Sanem ŞENER.
Trial summary
This planned randomized, single-blind clinical trial will investigate the effects of adding the Post-Isometric Relaxation (PIR) technique to a standard postural exercise program in individuals with moderate to severe temporomandibular joint dysfunction (TMD). Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes, Mandibular Dysfunction
- What is being tested?
- Postural Exercises + Post-Isometric Relaxation (PIR) Technique and Postural Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2025to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 25 years
- Diagnosis of moderate or severe temporomandibular joint dysfunction (TMD) according to the Fonseca Anamnestic Questionnaire
- Presence of TMD symptoms for at least 6 months
- No TMD treatment received within the last 6 months
- Presence of chewing muscle pain for at least 6 months
- Able and willing to participate in the study and follow the exercise program
- Signed informed consent form
Who cannot join
- History of jaw or facial trauma within the past year
- History of temporomandibular joint surgery
- Presence of systemic rheumatologic, neurological, or musculoskeletal disorders affecting the jaw, neck, or spine
- Pregnancy
- Current participation in another clinical trial
- Inability to perform the exercise program due to medical or physical limitations
- Refusal to provide informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Post-Isometric Relaxation Technique on Cervical Range of Motion, Mandibular Mobility, Head Anterior Tilt, and Kyphotic Posture in Individuals With Temporomandibular Joint Dysfunction
This planned randomized, single-blind clinical trial will investigate the effects of adding the Post-Isometric Relaxation (PIR) technique to a standard postural exercise program in individuals with moderate to severe temporomandibular joint dysfunction (TMD). Forty volunteers aged 18-25 years will be recruited and randomly assigned to either an experimental group (postural exercises + PIR) or a control group (postural exercises only). The intervention will be delivered three times per week for six weeks. Primary outcomes will include cervical range of motion, mandibular mobility, head anterior tilt, and thoracic kyphosis index, measured before and after the intervention. The study aims to determine whether PIR provides additional benefits to standard postural exercises in improving jaw and neck function and postural alignment in young adults with TMD.
Read the detailed description
Temporomandibular joint dysfunction (TMD) is a common musculoskeletal condition characterized by jaw pain, limited mouth opening, and joint sounds, often accompanied by postural deviations such as forward head posture and thoracic kyphosis. Conservative treatments, including postural exercises and manual therapy, are recommended to improve jaw and neck function and reduce symptoms.
The Post-Isometric Relaxation (PIR) technique is a manual therapy method that uses gentle isometric contractions followed by passive stretching to reduce muscle tension and increase mobility. While PIR has been shown to improve masticatory muscle function, its combined use with postural exercises in TMD management has not been fully evaluated.
In this planned study, forty volunteers aged 18-25 years with moderate or severe TMD (diagnosed using the Fonseca Anamnestic Questionnaire) will be recruited. Participants will be randomly assigned into two groups:
Experimental group: Postural exercise program + PIR technique
Control group: Postural exercise program only
The postural exercise program will include strengthening, stretching, and mobility exercises for the cervical and thoracic regions, performed three times per week for six weeks. In the experimental group, the PIR technique will be applied to jaw muscles according to a standardized protocol.
Outcome measures will include:
Cervical range of motion (flexion, extension, lateral flexion, rotation) measured with a goniometer
Mandibular mobility (depression, lateral deviation, protrusion) measured with a caliper
Head anterior tilt (chin-sternum distance, occiput-wall distance)
Thoracic kyphosis index measured with a flexicurve
Assessments will be conducted before the intervention and after the six-week program. The primary hypothesis is that the addition of PIR to postural exercises will produce greater improvements in cervical and mandibular mobility than postural exercises alone.
This trial is expected to provide new evidence for combining manual therapy with exercise in the management of TMD in young adults and may help guide future rehabilitation strategies.
- Being tested
- Postural Exercises + Post-Isometric Relaxation (PIR) Technique, Postural Exercises
- Keywords
- Temporomandibular Joint Dysfunction, Post-Isometric Relaxation, range of motion
- Medical subject headings
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postural Exercises + Post-Isometric Relaxation (PIR) TechniqueBehavioural
Participants will perform a standardized postural exercise program (strengthening, stretching, and mobility exercises for the cervical and thoracic regions) three times per week for six weeks. In addition, the Post-Isometric Relaxation (PIR) technique will be applied to jaw muscles during each session to reduce muscle tension and improve mandibular mobility.
Postural ExercisesBehavioural
Participants will perform a standardized postural exercise program designed to improve cervical and thoracic mobility and postural alignment. The program will include strengthening, stretching, and mobility exercises targeting the cervical spine, thoracic spine, and related musculature. Each session will last approximately 30-40 minutes and will be conducted three times per week for six weeks under the supervision of a trained therapist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm: Postural Exercises + Post-Isometric Relaxation (PIR) Technique | Experimental | Participants in this group will perform a standardized postural exercise program targeting cervical and thoracic regions, three times per week for six weeks. In addition, the Post-Isometric Relaxation (PIR) technique will be applied to the jaw muscles during each session, following a standardized manual therapy protocol to reduce muscle tension and improve mandibular mobility. Receives: Behavioral: Postural Exercises + Post-Isometric Relaxation (PIR) Technique; Behavioral: Postural Exercises |
| Control Arm: Postural Exercises Only | Active comparator | Participants in this group will perform the same standardized postural exercise program targeting cervical and thoracic regions, three times per week for six weeks, without the addition of the PIR technique. Receives: Behavioral: Postural Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mandibular depression (mouth opening)
The distance between the upper and lower central incisors during maximal mouth opening will be measured in millimeters using a caliper.
Measured: Baseline and after 6 weeks of intervention
Change in cervical range of motion
Cervical range of motion will be measured in degrees using a goniometer. Movements assessed will include flexion, extension, right and left lateral flexion, and right and left rotation.
Measured: Baseline and after 6 weeks of intervention
Change in mandibular lateral deviation (right and left)
The horizontal movement of the lower jaw to the right and left will be measured in millimeters using a caliper.
Measured: Baseline and after 6 weeks of intervention
Change in mandibular protrusion
The anterior translation of the mandible will be measured in millimeters using a caliper.
Outcome Measure: Change in head anterior tilt - chin-sternum distance
Measured: Baseline and after 6 weeks of intervention
Change in head anterior tilt - chin-sternum distance
The vertical distance from the midpoint of the chin to the superior border of the sternum will be measured in centimeters with a measuring tape.
Measured: Baseline and after 6 weeks of intervention
Change in head anterior tilt - occiput-wall distance
The distance between the occiput and the wall will be measured in centimeters while the participant stands in a natural posture against the wall.
Measured: Baseline and after 6 weeks of intervention
Change in thoracic kyphosis index
Thoracic kyphosis will be evaluated using a flexicurve ruler to measure curvature from C7 to T12. The thoracic kyphosis index will be calculated as (thoracic width / thoracic length) × 100.
Measured: Baseline and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start11 Aug 2025 (estimated)
- Primary completion22 Sep 2025 (estimated)
- Study completion25 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned into two parallel groups: the experimental group will receive postural exercises combined with the Post-Isometric Relaxation (PIR) technique, while the control group will receive postural exercises only. Both groups will follow the intervention protocol three times per week for six weeks, with no crossover between groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanem ŞENER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sanem ŞENER, Bulent Ecevit University
- Investigators
- Sanem ŞENER, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130279
- Sponsor's protocol ID
- TME-PIR-2024-01
- Acronym
- PIR-TMD
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study's ethics committee approval does not include provisions for external sharing of raw participant-level data. Data will be stored securely at Yeniyüzyıl University and will only be accessible to the research team for purposes of analysis and reporting
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Post-Isometric Relaxation Technique on Cervical Range of Motion, Mandibular Mobility, Head Anterior Tilt, and Kyphotic Posture in Individuals With Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT07130279
- Acronym / sponsor ID
- PIR-TMD / TME-PIR-2024-01
- Keywords
- Temporomandibular Joint Dysfunction, Post-Isometric Relaxation, range of motion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sanem ŞENERUniversity, hospital or other
- Study start
- 11 Aug 2025 (estimated)
- Primary completion
- 22 Sep 2025 (estimated)
- Study completion
- 25 Sep 2025 (estimated)
- First posted
- 19 Aug 2025 (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 planned randomized, single-blind clinical trial will investigate the effects of adding the Post-Isometric Relaxation (PIR) technique to a standard postural exercise program in individuals with moderate to severe temporomandibular joint dysfunction (TMD). Forty volunteers aged 18-25 years will be recruited and randomly assigned to either an experimental group (postural exercises + PIR) or a control group (postural exercises only). The intervention will be delivered three times per week for six weeks. Primary outcomes will include cervical range of motion, mandibular mobility, head anterior tilt, and thoracic kyphosis index, measured before and after the intervention. The study aims to determine whether PIR provides additional benefits to standard postural exercises in improving jaw and neck function and postural alignment in young adults with TMD.
Detailed description
Temporomandibular joint dysfunction (TMD) is a common musculoskeletal condition characterized by jaw pain, limited mouth opening, and joint sounds, often accompanied by postural deviations such as forward head posture and thoracic kyphosis. Conservative treatments, including postural exercises and manual therapy, are recommended to improve jaw and neck function and reduce symptoms.
The Post-Isometric Relaxation (PIR) technique is a manual therapy method that uses gentle isometric contractions followed by passive stretching to reduce muscle tension and increase mobility. While PIR has been shown to improve masticatory muscle function, its combined use with postural exercises in TMD management has not been fully evaluated.
In this planned study, forty volunteers aged 18-25 years with moderate or severe TMD (diagnosed using the Fonseca Anamnestic Questionnaire) will be recruited. Participants will be randomly assigned into two groups:
Experimental group: Postural exercise program + PIR technique
Control group: Postural exercise program only
The postural exercise program will include strengthening, stretching, and mobility exercises for the cervical and thoracic regions, performed three times per week for six weeks. In the experimental group, the PIR technique will be applied to jaw muscles according to a standardized protocol.
Outcome measures will include:
Cervical range of motion (flexion, extension, lateral flexion, rotation) measured with a goniometer
Mandibular mobility (depression, lateral deviation, protrusion) measured with a caliper
Head anterior tilt (chin-sternum distance, occiput-wall distance)
Thoracic kyphosis index measured with a flexicurve
Assessments will be conducted before the intervention and after the six-week program. The primary hypothesis is that the addition of PIR to postural exercises will produce greater improvements in cervical and mandibular mobility than postural exercises alone.
This trial is expected to provide new evidence for combining manual therapy with exercise in the management of TMD in young adults and may help guide future rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups: the experimental group will receive postural exercises combined with the Post-Isometric Relaxation (PIR) technique, while the control group will receive postural exercises only. Both groups will follow the intervention protocol three times per week for six weeks, with no crossover between groups.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm: Postural Exercises + Post-Isometric Relaxation (PIR) Technique | Experimental | Behavioral: Postural Exercises + Post-Isometric Relaxation (PIR) Technique, Behavioral: Postural ExercisesParticipants in this group will perform a standardized postural exercise program targeting cervical and thoracic regions, three times per week for six weeks. In addition, the Post-Isometric Relaxation (PIR) technique will be applied to the jaw muscles during each session, following a standardized manual therapy protocol to reduce muscle tension and improve mandibular mobility. |
| Control Arm: Postural Exercises Only | Active comparator | Behavioral: Postural ExercisesParticipants in this group will perform the same standardized postural exercise program targeting cervical and thoracic regions, three times per week for six weeks, without the addition of the PIR technique. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age between 18 and 25 years
- Diagnosis of moderate or severe temporomandibular joint dysfunction (TMD) according to the Fonseca Anamnestic Questionnaire
- Presence of TMD symptoms for at least 6 months
- No TMD treatment received within the last 6 months
- Presence of chewing muscle pain for at least 6 months
Key exclusion criteria (7 listed)
- History of jaw or facial trauma within the past year
- History of temporomandibular joint surgery
- Presence of systemic rheumatologic, neurological, or musculoskeletal disorders affecting the jaw, neck, or spine
- Pregnancy
- Current participation in another clinical trial
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 |
|---|---|---|
| Postural Exercises + Post-Isometric Relaxation (PIR) TechniqueParticipants will perform a standardized postural exercise program (strengthening, stretching, and mobility exercises for the cervical and thoracic regions) three times per week for six weeks. In addition, the Post-Isometric Relaxation (PIR) technique will be applied to jaw muscles during each session to reduce muscle tension and improve mandibular mobility. | Behavioural | Experimental Arm: Postural Exercises + Post-Isometric Relaxation (PIR) Technique |
| Postural ExercisesParticipants will perform a standardized postural exercise program designed to improve cervical and thoracic mobility and postural alignment. The program will include strengthening, stretching, and mobility exercises targeting the cervical spine, thoracic spine, and related musculature. Each session will last approximately 30-40 minutes and will be conducted three times per week for six weeks under the supervision of a trained therapist. | Behavioural | Control Arm: Postural Exercises Only, Experimental Arm: Postural Exercises + Post-Isometric Relaxation (PIR) Technique |
Primary outcome
Change in mandibular depression (mouth opening)
Time frame: Baseline and after 6 weeks of intervention
The distance between the upper and lower central incisors during maximal mouth opening will be measured in millimeters using a caliper.
Change in cervical range of motion
Time frame: Baseline and after 6 weeks of intervention
Cervical range of motion will be measured in degrees using a goniometer. Movements assessed will include flexion, extension, right and left lateral flexion, and right and left rotation.
Change in mandibular lateral deviation (right and left)
Time frame: Baseline and after 6 weeks of intervention
The horizontal movement of the lower jaw to the right and left will be measured in millimeters using a caliper.
Change in mandibular protrusion
Time frame: Baseline and after 6 weeks of intervention
The anterior translation of the mandible will be measured in millimeters using a caliper. Outcome Measure: Change in head anterior tilt - chin-sternum distance
Change in head anterior tilt - chin-sternum distance
Time frame: Baseline and after 6 weeks of intervention
The vertical distance from the midpoint of the chin to the superior border of the sternum will be measured in centimeters with a measuring tape.
Change in head anterior tilt - occiput-wall distance
Time frame: Baseline and after 6 weeks of intervention
The distance between the occiput and the wall will be measured in centimeters while the participant stands in a natural posture against the wall.
Change in thoracic kyphosis index
Time frame: Baseline and after 6 weeks of intervention
Thoracic kyphosis will be evaluated using a flexicurve ruler to measure curvature from C7 to T12. The thoracic kyphosis index will be calculated as (thoracic width / thoracic length) × 100.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study's ethics committee approval does not include provisions for external sharing of raw participant-level data. Data will be stored securely at Yeniyüzyıl University and will only be accessible to the research team for purposes of analysis and reporting
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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.
Sanem ŞENER principal investigator
Zonguldak Bulent Ecevit University
Questions about this trial
What is this clinical trial studying?
A study testing Postural Exercises + Post-Isometric Relaxation (PIR) Technique and Postural Exercises in people with Temporomandibular Joint Disorders and Myofascial Pain Syndromes, run by Sanem ŞENER.
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 7 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: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanem ŞENER (+90 5535918396, sanemsener@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mandibular depression (mouth opening) (time frame: Baseline and after 6 weeks of intervention). The study lists 7 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 19 Aug 2025.