Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-29 @ 5:51 PM
Study NCT ID:
NCT04540250
Status:
COMPLETED
Last Update Posted:
2020-09-07
First Post:
2020-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate
Sponsor:
Beni-Suef University
Organization:
Study Overview
Official Title:
Stratification of Oral Lesions in Methotrexate-treated Rheumatoid Arthritis Patients
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study included rheumatoid arthritis patients receiving Methotrexate as monotherapy. All eligible patients were subjected to thorough clinical examination and full history to identify oral events. Drug history, current dose and duration of MTX were recorded.
Detailed Description:
The current study was conducted in the Clinics of Oral Medicine, Faculty of Dentistry and Rheumatology, Faculty of Medicine - Cairo University from 2017 to 2019. This study followed the principles of the Helsinki Declaration and was approved by the Research ethics committee of Faculty of Dentistry, Cairo University.
RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded.
All eligible patients were subjected to thorough clinical examination for the whole oral cavity. Medical history and history of any oral manifestation were recorded. Drug history, dose, and duration of MTX were recorded.
Categorical data was presented as frequencies and percentages. Continuous data was described as means and standard deviations. Means were compared by one-way ANNOVA and Student-t-test. The significance level was set at P ≤0.05. Statistical analysis was performed with IBM® SPSS® Statistics Version 25 for Windows.
RA patients receiving MTX as monotherapy were included in the study. Patients suffering from systemic disease known to cause oral manifestations; salivary gland diseases and malignancies were excluded.
All eligible patients were subjected to thorough clinical examination for the whole oral cavity. Medical history and history of any oral manifestation were recorded. Drug history, dose, and duration of MTX were recorded.
Categorical data was presented as frequencies and percentages. Continuous data was described as means and standard deviations. Means were compared by one-way ANNOVA and Student-t-test. The significance level was set at P ≤0.05. Statistical analysis was performed with IBM® SPSS® Statistics Version 25 for Windows.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: