Temporomandibular ArthritisNCT03279016
Arthroscopic Guided Synovial Biopsies
An observational study of Temporomandibular Arthritis, run by Cairo University at 2 sites in Egypt.
Trial summary
To detect accuracy of serology in diagnosis of temporomandibular joint arthritis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Arthritis
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- May 2018to Dec 2019
- 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: patient complaing from arthritis symptoms,an diagnosed as arthritic patient with MRI
Who may be able to join
- Patients suffering from TEMPOROMANDIBULAR JOINT ARTHRITIS.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent
Who cannot join
- Patients with any systemic disease that may affect normal healing.
- Pregnant females.
- Patients with acute infection.
- Patients with bony ankyloses.
- Patients with risk of tumor dissemination.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Completed
Faculty of Oral and Dental Medicine
Cairo
- Recruiting
Faculty of Oral and Dental Medicine
Cairo
REEM HAMDY, PHD, +201006250787, reemhamdy@hotmail.com
About this study
Official title: Diagnosis of Temporomandibular Joint Arthritic Disease Using Arthroscopic Guided Synovial Biopsies
To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.
Read the detailed description
According to a search of previously published studies on accuracy of serology no sensitivity or specificity data was found regarding accurate detection of arthritis through serology, hence the aim of this study is to detect accuracy of serology in diagnosis of temporomandibular joint arthritis.
- Conditions
- Temporomandibular Arthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of serology
To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis
Measured: 2 years
Secondary outcomes (7)
Rheumatoid factor
To be measured in a blood sample with (IU/mL) unit as The normal reference range for RF is less than 15 IU/mL
Measured: 2 years
C-reactive protein
To be measured in a blood sample with (mg/dL) unit where Normal CRP levels are below 3.0 mg/dL.
Measured: 2 years
Anti-Cyclic Citrullinated Peptide
To be measured in a blood sample with (titre-AU)
Measured: 2 years
ANA
To be measured in a blood sample with binary outcome (positive or negative)
Measured: 2 years
HLA-B27
To be measured in a blood sample with binary outcome (positive or negative)
Measured: 2 years
Cellular population- type
Presence of inflammatory cells infiltrate at the synovial membrane biopsy :
- type of cells
Measured: 2 years
Cellular population- number of cells
Presence of inflammatory cells infiltrate at the synovial membrane biopsy:
- mean number of cells
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startMay 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular ArthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel EISSA, Cairo University
- Investigators
- sameh mekhaimer, professor, Study director, professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279016
- Sponsor's protocol ID
- CEBD-CU-2017-08-28
- Status last verified
- Feb 2018
- First submitted
- 31 Aug 2017
- Last updated
- 6 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Temporomandibular Joint Arthritic Disease Using Arthroscopic Guided Synovial Biopsies
- ClinicalTrials.gov ID
- NCT03279016
- Acronym / sponsor ID
- CEBD-CU-2017-08-28
- Conditions
- Temporomandibular Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 12 Sep 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.
To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.
Detailed description
According to a search of previously published studies on accuracy of serology no sensitivity or specificity data was found regarding accurate detection of arthritis through serology, hence the aim of this study is to detect accuracy of serology in diagnosis of temporomandibular joint arthritis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patient complaing from arthritis symptoms,an diagnosed as arthritic patient with MRI
Key inclusion criteria (3 listed)
- Patients suffering from TEMPOROMANDIBULAR JOINT ARTHRITIS.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent
Key exclusion criteria (5 listed)
- Patients with any systemic disease that may affect normal healing.
- Pregnant females.
- Patients with acute infection.
- Patients with bony ankyloses.
- Patients with risk of tumor dissemination.
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
accuracy of serology
Time frame: 2 years
To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis
7 secondary outcomes
Rheumatoid factor
Time frame: 2 years
C-reactive protein
Time frame: 2 years
Anti-Cyclic Citrullinated Peptide
Time frame: 2 years
ANA
Time frame: 2 years
HLA-B27
Time frame: 2 years
Cellular population- type
Time frame: 2 years
Cellular population- number of cells
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Temporomandibular Arthritis
RecruitingObservational study
Dysphagia in Rheumatoid Arthritis
Rheumatoid Arthritis (RA
Enrolling by invitationPhase 2/3
Effectiveness of iPRF Injections in Temporomandibular Joints Degeneration Management
Temporomandibular Disorder, Temporomandibular Joint Disorders
Not yet recruitingObservational study
CBCT and Audiological Analysis of the TMJ-Tinnitus Relationship
Tinnitus, Temporomandibular Joint Disorders
Not yet recruitingObservational study
Clinical, Microbial and Tissue-based Characterization of Patients Treated for Severe Temporomandibular Joint Pathology
TMJ Disorder, Ankylosis
Recruiting
Exploring Radiotherapy of Temporomandibular Joint Arthritis
Arthritis of Temporomandibular Joint
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.
sameh mekhaimer, professor study director
professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Arthritis, run by Cairo University at 2 sites in Egypt.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AHMED EISSA, MASTER (+201147700383, drahmedadel75@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of serology (time frame: 2 years). 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 6 Feb 2018.