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OpenTrials
Completed

NCT Number: NCT04540250

Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

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.

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Key information

Conditions

Methotrexate Adverse Reaction Mouth Diseases Oral Mucositis Stomatitis Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with Rheumatoid arthritis using methotrexate as sole treatment

Exclusion criteria

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

Treatment and study plan

Questionnaire

Other

conventional intra-oral examination and questionnaire

Other names: intra-oral examination

Primary outcomes

  1. occurrence of oral mucositis

    Time frame: throughout the study time (one year)

    Clinical examination (intra-oral) and history of oral mucositis where recorded

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Stratification of Oral Lesions in Methotrexate-treated Rheumatoid Arthritis Patients

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2020
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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