- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279691
Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis
February 19, 2020 updated by: Naglaa Elwakeel, October University for Modern Sciences and Arts
Synovial and Gingival Crevicular Fluid Levels of Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis
In this study we will assess the presence of prolactin hormone in the gingival crevicular fluid , and synovial fluid of patient with rheumatoid arthritis and periodontitis
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Egyptian patients with active rheumatoid arthritis and periodontitis.
Description
Inclusion Criteria:
- for first group patients with active rheumatoid arthritis with periodontitis.
- second group , patients with periodontitis and otherwise systemically healthy
- third group, systemically and periodontallly healthy subjects
Exclusion Criteria:
- smokers,
- pregnant or lactating females
- patients taking medications the affects levels of prolactin hormone.
- no periodontal treatment in the past six months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
periodontitis and rheumatoid arthritis
group 1: patiernts with periodontitis and rheumatoid arthritis.
only
|
|
periodontitis
group 2: patiernts with periodontitis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prolactin hormone levels in the tested media
Time Frame: 24 hours
|
changes in prolactin hormone expression in the tested media
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2020
Primary Completion (Anticipated)
April 1, 2020
Study Completion (Anticipated)
April 1, 2020
Study Registration Dates
First Submitted
February 19, 2020
First Submitted That Met QC Criteria
February 19, 2020
First Posted (Actual)
February 21, 2020
Study Record Updates
Last Update Posted (Actual)
February 21, 2020
Last Update Submitted That Met QC Criteria
February 19, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETH14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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