Temporomandibular DisordersNCT03736408
Frequency of Occurrence of the Pain Form of Temporomandibular Joint Dysfunction
An observational study of Temporomandibular Disorders, run by Jagiellonian University at 1 site in Poland.
Trial summary
Temporomandibular joint dysfunction (TMJD) includes disorders of the masticatory muscles in the stomatognathic system, temporomandibular joints and the surrounding structures. They are often associated with abnormal conditions of occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders
- How many people
- 334 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2018to 30 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study enrolled a group of 334 patients of both sexes, who reported to the prosthodontic treatment in Consulting Room of Temporomandibular Joint Dysfunction at Dental Institute at Jagiellonian University in Cracow, between January 2015 to June 2018, due to the pain and painless form of the temporomandibular joints dysfunctions.
Who may be able to join
- pain and painless form of temporomandibular joints dysfunction,
- required age range (>18 years)
- good general state of health
Who cannot join
- the will of the patient,
- emergence of general diseases,
- trauma,
- local inflammation.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jagiellonian University Department of Prosthetic Dentistry
Krakow, Lesser Poland Voivodeship, 31-155
About this study
Temporomandibular joint dysfunction (TMJD) includes disorders of the masticatory muscles in the stomatognathic system, temporomandibular joints and the surrounding structures. They are often associated with abnormal conditions of occlusion. The term "functional disorders" does not include all diseases of the muscular and joint system, like inflammatory, degenerative changes and cancer lesions of the muscles (multiple sclerosis, tetany, dermatomyositis). They are often the result of excessive and prolonged muscle hyperactivities and excessive work that cause non-physiological loads occurring in temporomandibular joints
Read the detailed description
Temporomandibular joint dysfunction (TMJD) includes disorders of the masticatory muscles in the stomatognathic system, temporomandibular joints and the surrounding structures. They are often associated with abnormal conditions of occlusion. The term "functional disorders" does not include all diseases of the muscular and joint system, like inflammatory, degenerative changes and cancer lesions of the muscles (multiple sclerosis, tetany, dermatomyositis). They are often the result of excessive and prolonged muscle hyperactivities and excessive work that cause non-physiological loads occurring in temporomandibular joints.
Certainly the most common complaint in this group of patients is muscle pain, which may range from slight tenderness to extreme discomfort. However, the origin of that pain is most often associated with increased levels of muscular use. Clinically this is seen as an inability to open the mouth widely. The restriction may be at any degree of opening depending on where the discomfort is felt. Local muscle soreness is a primary non-inflammatory muscular pain discomfort. It is often the first response of the muscle tissue to prolonged excessive contraction and is the most common type of acute muscle pain in dental practice.
The pain form of the disease is manifested by spontaneous pain in the preaural region, accompanied by pain or tenderness of the mastication muscle. Pain that appears during palpation examination of temporomandibular joints is frequently not related to inflammation of the soft tissue around the temporomandibular joints, as it is claimed by several authors of the paper. The cause of this problem is a long-term overload of soft tissue causally associated with excessive muscle tension, that sometimes even persists for years.
Due to an etiological factor, very important information associated with emotional tension and stress as well as sleep disturbances in relation to other pain complaints were verified.
The aim of the study was to carry out a retrospective assessment of the frequency of the pain form of functional disorders based on the analysis of medical records (results of a physical examination and a specialized functional test) of patients treated at the Consulting Room of Temporomandibular Joint Dysfunction.
- Conditions
- Temporomandibular Disorders
- Keywords
- temporomandibular joint dysfunction, pain form, treatment, epidemiologcal assessment
- 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 |
|---|---|---|
| 1. Group without Pain - TMJ disorders symptoms | 1. The symptoms concerning joints were: the type of sound symptoms (clicking or popping), their frequency and the phase of the movement of lowering and lifting the jaw during which they occurred, occurrence of the tension type headache or back pain. Hypertension of the mastication muscles is frequently connected with a parafunction activity like grinding or clenching the teeth, which cause abnormal pressure on the joints | |
| 2. Group with Pain and symptoms TMJ disorder | The pain form of the disease is manifested by spontaneous pain in the preaural region, accompanied by pain or tenderness of the mastication muscle. Pain that appears during palpation examination of temporomandibular joints is frequently not related to inflammation of the soft tissue around the temporomandibular joints, as it is claimed by several authors of the paper. The cause of this problem is a long-term overload of soft tissue causally associated with excessive muscle tension, that sometimes even persists for years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pain and painless type of the temporomandibular joint disorders.
The aim of the study was to carry out a retrospective assessment of the frequency of the pain form of functional disorders based on the analysis of medical records (results of a physical examination and a specialized functional test) of patients treated at the Consulting Room of Temporomandibular Joint Dysfunction.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 May 2018
- Primary completion1 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malgorzata Pihut, Jagiellonian University
- Investigators
- Małgorzata Pihut, Prof., Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736408
- Sponsor's protocol ID
- 1072.6120.57.2018
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 13 Nov 2018
- 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 13 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Occurrence of the Pain Form of Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT03736408
- Acronym / sponsor ID
- 1072.6120.57.2018
- Conditions
- Temporomandibular Disorders
- Keywords
- temporomandibular joint dysfunction, pain form, treatment, epidemiologcal assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 9 Nov 2018 (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.
Temporomandibular joint dysfunction (TMJD) includes disorders of the masticatory muscles in the stomatognathic system, temporomandibular joints and the surrounding structures. They are often associated with abnormal conditions of occlusion. The term "functional disorders" does not include all diseases of the muscular and joint system, like inflammatory, degenerative changes and cancer lesions of the muscles (multiple sclerosis, tetany, dermatomyositis). They are often the result of excessive and prolonged muscle hyperactivities and excessive work that cause non-physiological loads occurring in temporomandibular joints
Detailed description
Temporomandibular joint dysfunction (TMJD) includes disorders of the masticatory muscles in the stomatognathic system, temporomandibular joints and the surrounding structures. They are often associated with abnormal conditions of occlusion. The term "functional disorders" does not include all diseases of the muscular and joint system, like inflammatory, degenerative changes and cancer lesions of the muscles (multiple sclerosis, tetany, dermatomyositis). They are often the result of excessive and prolonged muscle hyperactivities and excessive work that cause non-physiological loads occurring in temporomandibular joints.
Certainly the most common complaint in this group of patients is muscle pain, which may range from slight tenderness to extreme discomfort. However, the origin of that pain is most often associated with increased levels of muscular use. Clinically this is seen as an inability to open the mouth widely. The restriction may be at any degree of opening depending on where the discomfort is felt. Local muscle soreness is a primary non-inflammatory muscular pain discomfort. It is often the first response of the muscle tissue to prolonged excessive contraction and is the most common type of acute muscle pain in dental practice.
The pain form of the disease is manifested by spontaneous pain in the preaural region, accompanied by pain or tenderness of the mastication muscle. Pain that appears during palpation examination of temporomandibular joints is frequently not related to inflammation of the soft tissue around the temporomandibular joints, as it is claimed by several authors of the paper. The cause of this problem is a long-term overload of soft tissue causally associated with excessive muscle tension, that sometimes even persists for years.
Due to an etiological factor, very important information associated with emotional tension and stress as well as sleep disturbances in relation to other pain complaints were verified.
The aim of the study was to carry out a retrospective assessment of the frequency of the pain form of functional disorders based on the analysis of medical records (results of a physical examination and a specialized functional test) of patients treated at the Consulting Room of Temporomandibular Joint Dysfunction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Group without Pain - TMJ disorders symptoms | – | –1. The symptoms concerning joints were: the type of sound symptoms (clicking or popping), their frequency and the phase of the movement of lowering and lifting the jaw during which they occurred, occurrence of the tension type headache or back pain. Hypertension of the mastication muscles is frequently connected with a parafunction activity like grinding or clenching the teeth, which cause abnormal pressure on the joints |
| 2. Group with Pain and symptoms TMJ disorder | – | –The pain form of the disease is manifested by spontaneous pain in the preaural region, accompanied by pain or tenderness of the mastication muscle. Pain that appears during palpation examination of temporomandibular joints is frequently not related to inflammation of the soft tissue around the temporomandibular joints, as it is claimed by several authors of the paper. The cause of this problem is a long-term overload of soft tissue causally associated with excessive muscle tension, that sometimes even persists for years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study enrolled a group of 334 patients of both sexes, who reported to the prosthodontic treatment in Consulting Room of Temporomandibular Joint Dysfunction at Dental Institute at Jagiellonian University in Cracow, between January 2015 to June 2018, due to the pain and painless form of the temporomandibular joints dysfunctions.
Key inclusion criteria (3 listed)
- pain and painless form of temporomandibular joints dysfunction,
- required age range (>18 years)
- good general state of health
Key exclusion criteria (4 listed)
- the will of the patient,
- emergence of general diseases,
- trauma,
- local inflammation.
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
Comparison of pain and painless type of the temporomandibular joint disorders.
Time frame: 12 months
The aim of the study was to carry out a retrospective assessment of the frequency of the pain form of functional disorders based on the analysis of medical records (results of a physical examination and a specialized functional test) of patients treated at the Consulting Room of Temporomandibular Joint Dysfunction.
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 13 Nov 2018.
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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.
Małgorzata Pihut, Prof. principal investigator
Jagiellonian 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 Disorders, run by Jagiellonian University at 1 site in Poland.
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 13 Nov 2018. 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 Poland. 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?
Comparison of pain and painless type of the temporomandibular joint disorders. (time frame: 12 months). 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 13 Nov 2018.