- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03065608
Evaluation of C-reactive Protein Level in the Group of Patient With Pain Form of Temporomandibular Joint Dysfunction
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Factors for exclusion from the research include: the will of the patient, the emergence of general diseases, trauma, or local inflammation.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Study Group
The study group included 36 patients with pain form of dysfunction.
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Control Group
The control group consisted of 36 patients with painless form of disorder.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Małgorzata Pihut, Associate Professor, Jagiellonian University
- Study Chair: Piotr Ceranowicz, MD,PhD,, Jagiellonian University
- Study Chair: Andrzej Gala, DDS,PhD,, Jagiellonian University
- Study Chair: Mieszko Więckiewicz, DMD,PhD,, Wroclaw Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KBET/125/L/2013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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