NCT03279016

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

August 31, 2017

Last Update Submit

February 4, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy of serology

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

    2 years

Secondary Outcomes (7)

  • Rheumatoid factor

    2 years

  • C-reactive protein

    2 years

  • Anti-Cyclic Citrullinated Peptide

    2 years

  • ANA

    2 years

  • HLA-B27

    2 years

  • +2 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Oral and Dental Medicine

Cairo, Egypt

COMPLETED

Faculty of Oral and Dental Medicine

Cairo, Egypt

RECRUITING

Study Officials

  • sameh mekhaimer, professor

    professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university

    STUDY DIRECTOR

Central Study Contacts

AHMED EISSA, MASTER

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 12, 2017

Study Start

May 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

February 6, 2018

Record last verified: 2018-02

Locations