Temporomandibular DisorderNCT04967131
Proprioceptive Neuromuscular Facilitation Exercises in Temporomandibular Dysfunction
An observational study of Temporomandibular Disorder and Temporomandibular Joint Disorders, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Individuals who were diagnosed with reduction disc displacement by Research Diagnostic criteria for Temporomandibular Disorder (TMD / RDC) were included in the study. Proprioceptive neuromuscular facilitation exercises were performed for 30 minutes using neck jaw and tongue patterns with rhythmic stabilization (RS)… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Temporomandibular Disorder, Temporomandibular Joint Disorders, Pain
- What is being tested?
- PNF exercises
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jan 2020to 31 Dec 2022
- 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
- Women only
- No healthy volunteers
- Adult
Study population: University students
Who may be able to join
- Volunteers between 18-25 years female, admitted to the study with clenching, grinding, clicking, jaw pain when eating hard foods, and limited and painful mouth movements.
Who cannot join
- Having orthopedic, neurological or rheumatological cervical disorders which affect the jaw motions; receiving occlusal therapy as a companion to treatment, those who have an operation in the area of jaw, head and neck and those with vertigo that prevents head movements during exercises.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: The Immediate Effect of Proprioceptive Neuromuscular Facilitation on Pain and Maximal Mouth Opening in Temporomandibular Dysfunction: Pilot Study
Individuals who were diagnosed with reduction disc displacement by Research Diagnostic criteria for Temporomandibular Disorder (TMD / RDC) were included in the study. Proprioceptive neuromuscular facilitation exercises were performed for 30 minutes using neck jaw and tongue patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques by physiotherapist. Maximal mouth openings were measured with caliper, pain intensities were measured with visual analogue scale and pressure pain thresholds with hand algometer.
Read the detailed description
TMD patients who are diagnosed by TMD/RDC are firstly assessed by physiotherapist for maximal mouth opening(MMO), pain intensity and pressure pain threshold. Then they will taught exercises with rhythmic initiation which includes repetation of the patern and 15 repetitions are applied as warm-up period. Proprioceptive neuromuscular facilitation (PNF) exercises are performed in the neck and jaw patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques. In the neck, right rotation-right lateral flexion, left rotation-left lateral flexion pattern, and the opening and closing pattern according to the working mechanics of the masseter and temporal muscle in the chin, RS and CI techniques are used. By providing maximum resistance in accordance with the needs of each individual, the RS protocol consist of isometric contractions that would not involve changing movements for 10 seconds. The combination of isotonics technique include combined concentric, isometric, and eccentric contraction of the agonist muscle for 5 seconds of each contraction without rest. CI exercises consist of 15 repetitions per set. A 30-second rest given between sets to include recovery. After exercises immediate MMO, pain intensity and pain treshold assessment will be applied.
- Being tested
- PNF exercises
- Keywords
- Orofacial Pain, Proprioceptive Neuromuscular Facilitation, Therapeutic Management, Threshold Pressure, Temporomandibular Joint Disorders, Pressure Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Pain, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNF exercisesOther
PNF exercises were applied in 3 sets of 15 repetitions based on movement in the diagonal plane, using head, neck and chin patterns. Contractions were sustained for at least 10 seconds.
| Study group | Role | What they receive |
|---|---|---|
| PNF group | Proprioceptive Neuromuscular Fascilitation exercises were given this group Receives: Other: PNF exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Treshold
The pain threshold will be measured with an algometer at certain points on the muscles in the area where the exercise is applied.
Measured: the immediate effect will be measured as soon as the exercise is finished
Pain intensity
The level of pain felt will be marked with a visual analog scale on a 10-centimeter paper.
Measured: the immediate effect will be measured as soon as the exercise is finished
Maximum mouth opening
Individuals will be asked to open their mouths as much as they can, and mouth opening will be measured with a caliper.
Measured: the immediate effect will be measured as soon as the exercise is finished
Secondary outcomes (3)
Unassisted opening
the individual is told to open their mouth and the gap is measured with a caliper.
Measured: the immediate effect will be measured as soon as the exercise is finished
maximum unassisted opening
Without trying to increase the mouth opening with hand or any help, the individual actively opens mouth as much as they can and the opening is measured with a caliper.
Measured: the immediate effect will be measured as soon as the exercise is finished
maximum assisted opening
It is measured with a caliper by asking individuals to open their mouths as much as they can and open more by helping with their hands at the last point.
Measured: the immediate effect will be measured as soon as the exercise is finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start7 Jan 2020
- Primary completion30 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem ergezen, Istanbul Medipol University Hospital
- Investigators
- Esra Atılgan, PhD, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04967131
- Sponsor's protocol ID
- 10840098-604.01.01-E.60748
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effect of Proprioceptive Neuromuscular Facilitation on Pain and Maximal Mouth Opening in Temporomandibular Dysfunction: Pilot Study
- ClinicalTrials.gov ID
- NCT04967131
- Acronym / sponsor ID
- 10840098-604.01.01-E.60748
- Keywords
- Orofacial Pain, Proprioceptive Neuromuscular Facilitation, Therapeutic Management, Threshold Pressure, Temporomandibular Joint Disorders, Pressure Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Jul 2021 (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.
Individuals who were diagnosed with reduction disc displacement by Research Diagnostic criteria for Temporomandibular Disorder (TMD / RDC) were included in the study. Proprioceptive neuromuscular facilitation exercises were performed for 30 minutes using neck jaw and tongue patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques by physiotherapist. Maximal mouth openings were measured with caliper, pain intensities were measured with visual analogue scale and pressure pain thresholds with hand algometer.
Detailed description
TMD patients who are diagnosed by TMD/RDC are firstly assessed by physiotherapist for maximal mouth opening(MMO), pain intensity and pressure pain threshold. Then they will taught exercises with rhythmic initiation which includes repetation of the patern and 15 repetitions are applied as warm-up period. Proprioceptive neuromuscular facilitation (PNF) exercises are performed in the neck and jaw patterns with rhythmic stabilization (RS) and combination of isotonics (CI) techniques. In the neck, right rotation-right lateral flexion, left rotation-left lateral flexion pattern, and the opening and closing pattern according to the working mechanics of the masseter and temporal muscle in the chin, RS and CI techniques are used. By providing maximum resistance in accordance with the needs of each individual, the RS protocol consist of isometric contractions that would not involve changing movements for 10 seconds. The combination of isotonics technique include combined concentric, isometric, and eccentric contraction of the agonist muscle for 5 seconds of each contraction without rest. CI exercises consist of 15 repetitions per set. A 30-second rest given between sets to include recovery. After exercises immediate MMO, pain intensity and pain treshold assessment will be applied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PNF group | – | Other: PNF exercisesProprioceptive Neuromuscular Fascilitation exercises were given this group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- University students
Key inclusion criteria (1 listed)
- Volunteers between 18-25 years female, admitted to the study with clenching, grinding, clicking, jaw pain when eating hard foods, and limited and painful mouth movements.
Key exclusion criteria (1 listed)
- Having orthopedic, neurological or rheumatological cervical disorders which affect the jaw motions; receiving occlusal therapy as a companion to treatment, those who have an operation in the area of jaw, head and neck and those with vertigo that prevents head movements during exercises.
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 |
|---|---|---|
| PNF exercisesPNF exercises were applied in 3 sets of 15 repetitions based on movement in the diagonal plane, using head, neck and chin patterns. Contractions were sustained for at least 10 seconds. | Other | PNF group |
Primary outcome
Pain Treshold
Time frame: the immediate effect will be measured as soon as the exercise is finished
The pain threshold will be measured with an algometer at certain points on the muscles in the area where the exercise is applied.
Pain intensity
Time frame: the immediate effect will be measured as soon as the exercise is finished
The level of pain felt will be marked with a visual analog scale on a 10-centimeter paper.
Maximum mouth opening
Time frame: the immediate effect will be measured as soon as the exercise is finished
Individuals will be asked to open their mouths as much as they can, and mouth opening will be measured with a caliper.
3 secondary outcomes
Unassisted opening
Time frame: the immediate effect will be measured as soon as the exercise is finished
maximum unassisted opening
Time frame: the immediate effect will be measured as soon as the exercise is finished
maximum assisted opening
Time frame: the immediate effect will be measured as soon as the exercise is finished
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 1 May 2025.
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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.
Esra Atılgan, PhD study chair
Medipol 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 and Temporomandibular Joint Disorders, run by Istanbul Medipol University Hospital 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 1 inclusion and 1 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 1 May 2025. 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?
Pain Treshold (time frame: the immediate effect will be measured as soon as the exercise is finished). The study lists 3 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 1 May 2025.