Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

Oral Mucositis Clinical Trial

Official title:

Stratification of Oral Lesions in Methotrexate-treated Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540250
• Other study ID #: BSU 5643
• Status: Completed
• Start date: January 2017
• Est. completion date: August 2019

Study information

• Verified date: August 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with Rheumatoid arthritis using methotrexate as sole treatment

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Methotrexate Adverse Reaction
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Other:
• questionnaire
conventional intra-oral examination and questionnaire

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of oral mucositis	Clinical examination (intra-oral) and history of oral mucositis where recorded	throughout the study time (one year)