Arthroscopic Guided Synovial Biopsies

• Conditions: Temporomandibular Arthritis

• Registration Number: NCT03279016
• Lead Sponsor: Cairo University

Brief Summary

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 Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-09-08
• Study First Posted: 2017-09-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-04
• Last Update Posted: 2018-02-06
• Study Start: 2018-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
accuracy of serology	2 years	To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis

Secondary Outcome Measures

Name	Time	Method
Cellular population- type	2 years	Presence of inflammatory cells infiltrate at the synovial membrane biopsy : - type of cells
Cellular population- number of cells	2 years	Presence of inflammatory cells infiltrate at the synovial membrane biopsy: - mean number of cells
C-reactive protein	2 years	To be measured in a blood sample with (mg/dL) unit where Normal CRP levels are below 3.0 mg/dL.
Rheumatoid factor	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
Anti-Cyclic Citrullinated Peptide	2 years	To be measured in a blood sample with (titre-AU)
HLA-B27	2 years	To be measured in a blood sample with binary outcome (positive or negative)
ANA	2 years	To be measured in a blood sample with binary outcome (positive or negative)

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine; 🇪🇬 Cairo, Egypt