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Arthroscopic Guided Synovial Biopsies

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ClinicalTrials.gov Identifier: NCT03279016
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : February 6, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Adel EISSA, Cairo University

Brief Summary:
To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.

Condition or disease
Temporomandibular 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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Diagnosis of Temporomandibular Joint Arthritic Disease Using Arthroscopic Guided Synovial Biopsies
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis Biopsy




Primary Outcome Measures :
  1. accuracy of serology [ Time Frame: 2 years ]
    To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis


Secondary Outcome Measures :
  1. Rheumatoid factor [ Time Frame: 2 years ]
    To be measured in a blood sample with (IU/mL) unit as The normal reference range for RF is less than 15 IU/mL

  2. C-reactive protein [ Time Frame: 2 years ]
    To be measured in a blood sample with (mg/dL) unit where Normal CRP levels are below 3.0 mg/dL.

  3. Anti-Cyclic Citrullinated Peptide [ Time Frame: 2 years ]
    To be measured in a blood sample with (titre-AU)

  4. ANA [ Time Frame: 2 years ]
    To be measured in a blood sample with binary outcome (positive or negative)

  5. HLA-B27 [ Time Frame: 2 years ]
    To be measured in a blood sample with binary outcome (positive or negative)

  6. Cellular population- type [ Time Frame: 2 years ]

    Presence of inflammatory cells infiltrate at the synovial membrane biopsy :

    - type of cells


  7. Cellular population- number of cells [ Time Frame: 2 years ]

    Presence of inflammatory cells infiltrate at the synovial membrane biopsy:

    - mean number of cells




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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient complaing from arthritis symptoms,an diagnosed as arthritic patient with MRI
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279016


Contacts
Contact: AHMED EISSA, MASTER +201147700383 drahmedadel75@gmail.com

Locations
Egypt
Faculty of Oral and Dental Medicine Completed
Cairo, Egypt
Faculty of Oral and Dental Medicine Recruiting
Cairo, Egypt
Contact: REEM HAMDY, PHD    +201006250787    reemhamdy@hotmail.com   
Sponsors and Collaborators
Cairo University
Investigators
Study Director: sameh mekhaimer, professor professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university

Responsible Party: Ahmed Adel EISSA, doctor, Cairo University
ClinicalTrials.gov Identifier: NCT03279016     History of Changes
Other Study ID Numbers: CEBD-CU-2017-08-28
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No