Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

Completed

• Conditions: Methotrexate Adverse Reaction; Oral Mucositis
• Interventions: Other: questionnaire

• Registration Number: NCT04540250
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study Start: 2017-01
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-31
• Last Update Submitted: 2020-08-31
• Study First Posted: 2020-09-07
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 804

Inclusion Criteria

• patients with Rheumatoid arthritis using methotrexate as sole treatment

Exclusion Criteria

• patients with Rheumatoid arthritis using any other treatments for Rheumatoid arthritis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group of Rheumatoid arthritis patients	questionnaire	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.

Primary Outcome Measures

Name	Time	Method
occurrence of oral mucositis	throughout the study time (one year)	Clinical examination (intra-oral) and history of oral mucositis where recorded