Rheumatoid ArthritisNCT04279691
Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis
An observational study of Rheumatoid Arthritis and Periodontitis, run by October University for Modern Sciences and Arts.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Periodontitis
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2020to Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Egyptian patients with active rheumatoid arthritis and periodontitis.
Who may be able to join
- 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
Who cannot join
- smokers,
- pregnant or lactating females
- patients taking medications the affects levels of prolactin hormone.
- no periodontal treatment in the past six months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- Rheumatoid Arthritis, Periodontitis
- Medical subject headings
- Arthritis, Rheumatoid, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| periodontitis and rheumatoid arthritis | group 1: patiernts with periodontitis and rheumatoid arthritis. only | |
| periodontitis | group 2: patiernts with periodontitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
prolactin hormone levels in the tested media
changes in prolactin hormone expression in the tested media
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Elwakeel, October University for Modern Sciences and Arts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279691
- Sponsor's protocol ID
- ETH14
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
El-Wakeel NM, Shalaby ZF, Abdulmaguid RF, Elhamed SSA, Shaker O. Local gingival crevicular fluid, synovial fluid, and circulating levels of prolactin hormone in patients with moderately active rheumatoid arthritis and stage III and IV periodontitis before and after non-surgical periodontal treatment-a controlled trial. Clin Oral Investig. 2023 Jun;27(6):2813-2821. doi: 10.1007/s00784-023-04867-w. Epub 2023 Jan 31.
PubMed 36717425
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synovial and Gingival Crevicular Fluid Levels of Prolactin Hormone in Rheumatoid Arthritis Patients With Periodontitis
- ClinicalTrials.gov ID
- NCT04279691
- Acronym / sponsor ID
- ETH14
- Conditions
- Rheumatoid Arthritis, Periodontitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| periodontitis and rheumatoid arthritis | – | –group 1: patiernts with periodontitis and rheumatoid arthritis. only |
| periodontitis | – | –group 2: patiernts with periodontitis |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Egyptian patients with active rheumatoid arthritis and periodontitis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- smokers,
- pregnant or lactating females
- patients taking medications the affects levels of prolactin hormone.
- no periodontal treatment in the past six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
prolactin hormone levels in the tested media
Time frame: 24 hours
changes in prolactin hormone expression in the tested media
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 36717425El-Wakeel NM, Shalaby ZF, Abdulmaguid RF, Elhamed SSA, Shaker O. Local gingival crevicular fluid, synovial fluid, and circulating levels of prolactin hormone in patients with moderately active rheumatoid arthritis and stage III and IV periodontitis before and after non-surgical periodontal treatment-a controlled trial. Clin Oral Investig. 2023 Jun;27(6):2813-2821. doi: 10.1007/s00784-023-04867-w. Epub 2023 Jan 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Periodontitis, run by October University for Modern Sciences and Arts.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naglaa El-Wakeel (01001757761, naglaelwakeel@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prolactin hormone levels in the tested media (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279691, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.