Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

Beni-Suef University

Status

Completed

Conditions

Methotrexate Adverse Reaction

Oral Mucositis

Treatments

Other: questionnaire

Study type

Observational

Funder types

Other

Identifiers

NCT04540250

BSU 5643

Details and patient eligibility

About

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.

Full 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.

Enrollment

804 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria