Arthroscopic Guided Synovial Biopsies

Temporomandibular Arthritis Clinical Trial

Official title:

Diagnosis of Temporomandibular Joint Arthritic Disease Using Arthroscopic Guided Synovial Biopsies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03279016
• Other study ID #: CEBD-CU-2017-08-28
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2017
• Last updated: February 4, 2018
• Start date: May 2018
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: AHMED EISSA, MASTER
• Phone: +201147700383
• Email: drahmedadel75[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Temporomandibular Arthritis

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine	Cairo
Egypt	Faculty of Oral and Dental Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy of serology	To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis	2 years
Secondary	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
Secondary	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
Secondary	Anti-Cyclic Citrullinated Peptide	To be measured in a blood sample with (titre-AU)	2 years
Secondary	ANA	To be measured in a blood sample with binary outcome (positive or negative)	2 years
Secondary	HLA-B27	To be measured in a blood sample with binary outcome (positive or negative)	2 years
Secondary	Cellular population- type	Presence of inflammatory cells infiltrate at the synovial membrane biopsy : - type of cells	2 years
Secondary	Cellular population- number of cells	Presence of inflammatory cells infiltrate at the synovial membrane biopsy: - mean number of cells	2 years