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Stratification of Oral Ulcers in Rheumatoid Arthritis Patients Kept on Methotrexate

Stratification of Oral Lesions in Methotrexate-treated Rheumatoid Arthritis Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04540250
Enrollment
804
Registered
2020-09-07
Start date
2017-01-31
Completion date
2019-08-31
Last updated
2020-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methotrexate Adverse Reaction, Oral Mucositis

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.

Interventions

OTHERquestionnaire

conventional intra-oral examination and questionnaire

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patients with Rheumatoid arthritis using methotrexate as sole treatment

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
occurrence of oral mucositisthroughout the study time (one year)Clinical examination (intra-oral) and history of oral mucositis where recorded

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026