Temporomandibular Joint DisordersNCT05187325
The Clinical Effects of Myofascial Trigger Points in Disc Replacement With Reduction
An observational study of Temporomandibular Joint Disorders and Myofascial Trigger Point Pain, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Myofascial Trigger Point Pain, Jaw Diseases
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 17 Feb 2022
- How long will I take part?
- 1 Day
- 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: The participants who ages between 18-65 years of both genders with disc displacement with reduction with/ without myofascial trigger points in master muscles will be included in the study.
Who may be able to join
- 18-65 years old of both genders.
- Presence of disc displacement with reduction with/without myofascial trigger points in master muscles.
- Being accepted of the participation in the study.
Who cannot join
- Lack of cognitive ability to understand test instructions, illiteracy, aphasia, presence of a known psychiatric illness
- Refusal to participate in the study
- Patients under the age of 18 and over the age of 65
- Having other temporomandibular joint disorders other than the diagnosis of RDD and/or myofascial trigger points
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Kucukcekmece, 34303
About this study
Official title: The Effect of Myofascial Trigger Points on Clinical Symptoms, Pain and Limitation of Temporomandibular Joint Function in Disc Displacement With Reduction
This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. These two groups will be compared for clinical findings, pain severity and limitation of the temporomadibular function.
Read the detailed description
This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. The participants' ages will be between 18-65 years of both genders.
These two groups will be compared for clinical findings with DC/TMD Axis I- Symptom Questionnaire, pain levels in the last 1 month with DC/TMD Axis II-Graded Chronic Pain Scale, and limitation of the temporomadibular function with DC/TMD Axis II-Jaw Functional Limitation Scale-8.
- Being tested
- no intervention
- Keywords
- temporomandibular joint, disc displacement with reduction, trigger point, pain level
- Medical subject headings
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes, Jaw Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| myofascial trigger point and disc displacement with reduction | the participants have myofascial trigger points in master muscle and also temporomandibular joint disc displacement with reduction. Receives: Other: no intervention | |
| disc displacement with reduction | the participants have only temporomandibular joint disc displacement with reduction. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
mouth opening distance
Maximal opening of mouth is described as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly or as the inter incisal distance plus the overbite.
Measured: 1 day
bruxism
bruxism is a stereotyped movement disorder characterized by grinding or clenching of the teeth
Measured: 1 day
limitation of the movement of the temporomandibular joint
limitation of the movement of the temporomandibular joint
Measured: 1 day
temporomandibular joint noises
noises of the temporomandibular joint
Measured: 1 day
locking of the temporomandibular joint
locking of the temporomandibular joint
Measured: 1 day
Graded Chronic pain Scale v.2.0
Version 2 of the GCPS includes, in addition to the 3 items for pain intensity and 4 items for function, one item for number of days of pain.
Measured: 1 day
Jaw Functional Limitation Scale-8
The JFLS was initially developed as an 8-item global scale for overall functional limitation of the masticatory system; based on the resultant items and supporting psychometric data, the instrument was re-developed in order to expand measured constructs to also include masticatory limitation, vertical mobility limitation, and verbal and non-verbal communication limitation.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start15 Dec 2021
- Primary completion15 Feb 2022
- Study completion17 Feb 2022
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Damla Korkmaz, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187325
- Sponsor's protocol ID
- KAEK/2021.11.309
- Status last verified
- Mar 2022
- First submitted
- 25 Dec 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be decided after the publication
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Myofascial Trigger Points on Clinical Symptoms, Pain and Limitation of Temporomandibular Joint Function in Disc Displacement With Reduction
- ClinicalTrials.gov ID
- NCT05187325
- Acronym / sponsor ID
- KAEK/2021.11.309
- Keywords
- temporomandibular joint, disc displacement with reduction, trigger point, pain level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 11 Jan 2022 (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 is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. These two groups will be compared for clinical findings, pain severity and limitation of the temporomadibular function.
Detailed description
This is a prospective, and controlled trial. 60 participants with myofascial trigger points and disc displacement with reduction and 60 participants with disc displacement with reduction will be included in the study. The participants' ages will be between 18-65 years of both genders.
These two groups will be compared for clinical findings with DC/TMD Axis I- Symptom Questionnaire, pain levels in the last 1 month with DC/TMD Axis II-Graded Chronic Pain Scale, and limitation of the temporomadibular function with DC/TMD Axis II-Jaw Functional Limitation Scale-8.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| myofascial trigger point and disc displacement with reduction | – | Other: no interventionthe participants have myofascial trigger points in master muscle and also temporomandibular joint disc displacement with reduction. |
| disc displacement with reduction | – | Other: no interventionthe participants have only temporomandibular joint disc displacement with reduction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants who ages between 18-65 years of both genders with disc displacement with reduction with/ without myofascial trigger points in master muscles will be included in the study.
Key inclusion criteria (3 listed)
- 18-65 years old of both genders.
- Presence of disc displacement with reduction with/without myofascial trigger points in master muscles.
- Being accepted of the participation in the study.
Key exclusion criteria (4 listed)
- Lack of cognitive ability to understand test instructions, illiteracy, aphasia, presence of a known psychiatric illness
- Refusal to participate in the study
- Patients under the age of 18 and over the age of 65
- Having other temporomandibular joint disorders other than the diagnosis of RDD and/or myofascial trigger points
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 |
|---|---|---|
| no interventionthere is no intervention | Other | disc displacement with reduction, myofascial trigger point and disc displacement with reduction |
Primary outcome
mouth opening distance
Time frame: 1 day
Maximal opening of mouth is described as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible painlessly or as the inter incisal distance plus the overbite.
bruxism
Time frame: 1 day
bruxism is a stereotyped movement disorder characterized by grinding or clenching of the teeth
limitation of the movement of the temporomandibular joint
Time frame: 1 day
limitation of the movement of the temporomandibular joint
temporomandibular joint noises
Time frame: 1 day
noises of the temporomandibular joint
locking of the temporomandibular joint
Time frame: 1 day
locking of the temporomandibular joint
Graded Chronic pain Scale v.2.0
Time frame: 1 day
Version 2 of the GCPS includes, in addition to the 3 items for pain intensity and 4 items for function, one item for number of days of pain.
Jaw Functional Limitation Scale-8
Time frame: 1 day
The JFLS was initially developed as an 8-item global scale for overall functional limitation of the masticatory system; based on the resultant items and supporting psychometric data, the instrument was re-developed in order to expand measured constructs to also include masticatory limitation, vertical mobility limitation, and verbal and non-verbal communication limitation.
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 31 Mar 2022.
- Individual participant dataSharing planned: Undecided. It will be decided after the publication
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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 Joint Disorders and Myofascial Trigger Point Pain, run by Kanuni Sultan Suleyman Training and Research 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 3 inclusion and 4 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 31 Mar 2022. 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?
mouth opening distance (time frame: 1 day). 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 31 Mar 2022.