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

The effect of folic acid mouthwash solution in prevention of head and neck radiotherapy –induced stomatitis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20180526039847N1
Enrollment
100
Registered
2019-06-19
Start date
2018-06-10
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Stomatitis caused by radiotherapy for head and neck. Oral mucositis (ulcerative)

Interventions

Intervention 1: Intervention group: Combined folic acid solution containing (folic acid = 100 mg, NaHCO3=38 mg, propyl parahydroxybenzoate = 25 mg, methyl parahydroxy benzoate = 50 mg, conc peppermint

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Mousa Mahdizadeh

Mashhad University of Medical Sciences

MahdizadehM@mums.ac.ir+98 51 3859 1511

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026