Arthroscopic Guided Synovial Biopsies

Diagnosis of Temporomandibular Joint Arthritic Disease Using Arthroscopic Guided Synovial Biopsies

To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Completed
    • Faculty of Oral and Dental Medicine
  • Cairo, Egypt
    • Recruiting
    • Faculty of Oral and Dental Medicine
    • Contact: REEM HAMDY, PHD; Phone Number: +201006250787; Email: reemhamdy@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patient complaing from arthritis symptoms,an diagnosed as arthritic patient with MRI

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of serology	To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	2 years
Anti-Cyclic Citrullinated Peptide	To be measured in a blood sample with (titre-AU)	2 years
ANA	To be measured in a blood sample with binary outcome (positive or negative)	2 years
HLA-B27	To be measured in a blood sample with binary outcome (positive or negative)	2 years
Cellular population- type	Presence of inflammatory cells infiltrate at the synovial membrane biopsy : - type of cells	2 years
Cellular population- number of cells	Presence of inflammatory cells infiltrate at the synovial membrane biopsy: - mean number of cells	2 years

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: sameh mekhaimer, professor, professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 8, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2018
• Last Update Submitted That Met QC Criteria: February 4, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: CEBD-CU-2017-08-28

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No