NCT04279691

Brief 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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

February 19, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

1 month

First QC Date

February 19, 2020

Last Update Submit

February 19, 2020

Conditions

Rheumatoid ArthritisPeriodontitis

Outcome Measures

Primary Outcomes (1)

  • prolactin hormone levels in the tested media

    changes in prolactin hormone expression in the tested media

    24 hours

Study Arms (2)

periodontitis and rheumatoid arthritis

group 1: patiernts with periodontitis and rheumatoid arthritis. only

periodontitis

group 2: patiernts with periodontitis

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Egyptian patients with active rheumatoid arthritis and periodontitis.

You may qualify if:

  • 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

You may not qualify if:

  • smokers,
  • pregnant or lactating females
  • patients taking medications the affects levels of prolactin hormone.
  • no periodontal treatment in the past six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36717425DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Synovial fluid and gingival crevicular fluid

MeSH Terms

Conditions

Arthritis, RheumatoidPeriodontitis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Naglaa El-Wakeel

CONTACT

01001757761naglaelwakeel@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 19, 2020

First Posted

February 21, 2020

Study Start

March 1, 2020

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share