CClinicalTrials.gg
Status unknownNCT03279016Updated Feb 6, 2018

Arthroscopic Guided Synovial Biopsies

An observational study in Temporomandibular Arthritis, sponsored by Cairo University. Status unknown at 2 sites in Egypt. Per ClinicalTrials.gov, last updated 2018-02-06.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
20
Sex
All
01

Study summary

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.

02

Conditions studied

  • Temporomandibular Arthritis

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

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.
04

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
20 participants (estimated)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. accuracy of serology

    To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis

    Time frame: 2 years

Secondary outcomes

  1. 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

    Time frame: 2 years

  2. C-reactive protein

    To be measured in a blood sample with (mg/dL) unit where Normal CRP levels are below 3.0 mg/dL.

    Time frame: 2 years

  3. Anti-Cyclic Citrullinated Peptide

    To be measured in a blood sample with (titre-AU)

    Time frame: 2 years

  4. ANA

    To be measured in a blood sample with binary outcome (positive or negative)

    Time frame: 2 years

  5. HLA-B27

    To be measured in a blood sample with binary outcome (positive or negative)

    Time frame: 2 years

  6. Cellular population- type

    Presence of inflammatory cells infiltrate at the synovial membrane biopsy : - type of cells

    Time frame: 2 years

  7. Cellular population- number of cells

    Presence of inflammatory cells infiltrate at the synovial membrane biopsy: - mean number of cells

    Time frame: 2 years

06

Study locations

1 of 2 sites recruiting
  • Faculty of Oral and Dental Medicine
    Cairo, Egypt
    Completed
  • Faculty of Oral and Dental Medicine
    Cairo, Egypt
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03279016
Lead sponsor
Cairo University
Responsible party
Ahmed Adel EISSA (doctor, Cairo University) — Principal investigator
First posted
Sep 12, 2017
Start date
May 2018 (estimated)
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Feb 6, 2018

Study contacts

AHMED EISSA, MASTER
Contact
drahmedadel75@gmail.com
+201147700383
sameh mekhaimer, professor
study director · professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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