The Effect of Folic Acid Mouthwash on Stomatitis Caused by Head and Neck radiotherapy

Phase 3

• Conditions: K12.3; Stomatitis caused by radiotherapy for head and neck.; Oral mucositis (ulcerative)

• Registration Number: IRCT20180526039847N1
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Satisfied to participate in the study
The mucous membrane is healthy and free from mucosal lesions and oral and dental problems
Age of 18 to 60 years
Receive external radiotherapy and radiation at a dose of 180 CGy per day for one hour
During the study, do not use any mouthwash and other medication for oral ulcers
Not having dentures

Exclusion Criteria

Having immunodeficiency disease and having leukopenia and leukocytosis
Having underlying illness (diabetes, kidney disease, liver disease)
There is a history of tobacco use, including smoking, hookah, and narcotics in the last month
Chemotherapy drugs receive simultaneous radiotherapy during the study
Receives sedative
During the study, do not use any mouthwash and other medication for oral ulcers

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of stomatitis. Timepoint: Before the start of the first and seventh and fourteenth days of Radiotherapy, the incidence of stomatitis, pain, mouth ulcers in patients' records. Method of measurement: The World Health Organization standard tool for measuring stomatitis, pain visual analog scale (Visual Analogue Scale), measuring instruments sores (oral mucositis assessment scale).