NCT04540250

Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

Stratification of Oral Lesions in Methotrexate-treated Rheumatoid Arthritis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 804 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Methotrexate Adverse Reaction
• Oral Mucositis

Interventions

Type	Name	Description
OTHER	questionnaire	conventional intra-oral examination and questionnaire

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2020-09-07
• Last updated: 2020-09-07

Regulatory

• FDA-regulated drug study