Temporomandibular Joint DisordersNCT03065608
Evaluation of C-reactive Protein Level in the Group of Patient With Pain Form of Temporomandibular Joint Dysfunction
An observational study of Temporomandibular Joint Disorders, run by Jagiellonian University.
Trial summary
Temporomandibular joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Joint Disorders
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study enrolled a group of 72 patients, aged 21 to 48 years, 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 February 2017, due to the pain and painless form of the temporomandibular joints dysfunction, and acoustic symptoms, accompanied by excessive tension of masticatory muscle. Symptoms persisted from 3 to 12 months prior to beginning of the treatment.
Who may be able to join
- Factors of inclusion in the study are: pain form of temporomandibular joints dysfunction, the required age range, a good general state of health (particularly with regard to cardiac and metabolic disorders).
Who cannot join
- Factors for exclusion from the research include: the will of the patient, the emergence of general diseases, trauma, or local inflammation.
About this study
Temporomandibular joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures.
The aim of the study was to compare the level of C-reactive protein in patients with pain and painless form of temporomandibular joints dysfunction.
Read the detailed description
Temporomandibular joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures.
The aim of the study was to compare the level of C-reactive protein in patients with pain and painless form of temporomandibular joints dysfunction.
Material and methods The research material consisted of 72 patients who reported to the prosthetic treatment because of temporomandibular joint dysfunction. The study group included 36 patients with pain form of dysfunction, and control group - 36 patients with painless form of disorder. Each patient underwent specialized examination of functional disorders, in order to diagnose the type of dysfunction and commissioned to carry out a study of the blood test concern with evaluation of the C-reactive protein (CRP) level in the same analytical laboratory.
The results of the investigation were subjected to statistical analysis.
- Conditions
- Temporomandibular Joint Disorders
- 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 |
|---|---|---|
| Study Group | The study group included 36 patients with pain form of dysfunction. | |
| Control Group | The control group consisted of 36 patients with painless form of disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
By means of the CRP-level it will be verified if the temporomandibular joint dysfunctions are associated with inflammations of the temporomandibular joints.
The aim of the study is to avaluation of the level of C-reactive protein in patients treated prosthetically due to the pain form of temporomandibular joints 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 posted28 Feb 2017
- Study startJan 2015
- Primary completionFeb 2017
- Study completionFeb 2017
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 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, Associate Professor, Principal investigator, Jagiellonian UniversityPiotr Ceranowicz, MD,PhD,, Study chair, Jagiellonian UniversityAndrzej Gala, DDS,PhD,, Study chair, Jagiellonian UniversityMieszko Więckiewicz, DMD,PhD,, Study chair, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065608
- Sponsor's protocol ID
- KBET/125/L/2013
- Status last verified
- Feb 2017
- First submitted
- 17 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of C-reactive Protein Level in the Group of Patient With Pain Form of Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT03065608
- Acronym / sponsor ID
- KBET/125/L/2013
- Conditions
- Temporomandibular Joint Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 28 Feb 2017 (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 joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures.
The aim of the study was to compare the level of C-reactive protein in patients with pain and painless form of temporomandibular joints dysfunction.
Detailed description
Temporomandibular joints dysfunction is a functional disorder concern with the abnormal functioning of the muscles of the stomatognathic system, temporomandibular joints involved in the dynamic movements of the jaw and surrounding structures.
The aim of the study was to compare the level of C-reactive protein in patients with pain and painless form of temporomandibular joints dysfunction.
Material and methods The research material consisted of 72 patients who reported to the prosthetic treatment because of temporomandibular joint dysfunction. The study group included 36 patients with pain form of dysfunction, and control group - 36 patients with painless form of disorder. Each patient underwent specialized examination of functional disorders, in order to diagnose the type of dysfunction and commissioned to carry out a study of the blood test concern with evaluation of the C-reactive protein (CRP) level in the same analytical laboratory.
The results of the investigation were subjected to statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –The study group included 36 patients with pain form of dysfunction. |
| Control Group | – | –The control group consisted of 36 patients with painless form of disorder. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study enrolled a group of 72 patients, aged 21 to 48 years, 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 February 2017, due to the pain and painless form of the temporomandibular joints dysfunction, and acoustic symptoms, accompanied by excessive tension of masticatory muscle. Symptoms persisted from 3 to 12 months prior to beginning of the treatment.
Key inclusion criteria (1 listed)
- Factors of inclusion in the study are: pain form of temporomandibular joints dysfunction, the required age range, a good general state of health (particularly with regard to cardiac and metabolic disorders).
Key exclusion criteria (1 listed)
- Factors for exclusion from the research include: the will of the patient, the emergence of general diseases, trauma, or 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
By means of the CRP-level it will be verified if the temporomandibular joint dysfunctions are associated with inflammations of the temporomandibular joints.
Time frame: 12 months
The aim of the study is to avaluation of the level of C-reactive protein in patients treated prosthetically due to the pain form of temporomandibular joints 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 28 Feb 2017.
- Individual participant dataSharing planned: No
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Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
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R01_Pilot Jaw Muscle Phenotypes
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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, Associate Professor principal investigator
Jagiellonian University
Piotr Ceranowicz, MD,PhD, study chair
Jagiellonian University
Andrzej Gala, DDS,PhD, study chair
Jagiellonian University
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Joint Disorders, run by Jagiellonian University.
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 28 Feb 2017. 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?
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?
By means of the CRP-level it will be verified if the temporomandibular joint dysfunctions are associated with inflammations of the temporomandibular joints. (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 28 Feb 2017.