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Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy

Comparative effects of Vitamin E, Hyaloronic acid and Triamcinolone combination versus Triamcinolone alone on oral mucositis induced by radiotherapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190428043407N1
Enrollment
58
Registered
2019-07-20
Start date
2019-07-23
Completion date
Unknown
Last updated
2020-10-06

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

Conditions

Oral mucositis induced by radiotherapy. Oral mucositis (ulcerative) due to radiation

Interventions

Intervention 1: Intervention group: Treatment of patients with oral mucositis induced by head and neck radiotherapy by mouthwash contains of vit E , hyaluronic acid and triamcinolone. Intervention 2:

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient entry requirements include: Patients with (at least 18 years of age) (no maximum age limit, Patients with definite cervical cancer diagnosis according to histopathologic examination, Observe oral hygiene in a way that does not prevent the degree of mucositis severity, The patient has the ability to use mouthwash, Grade 3 and 4 oral mucositis according to WHO grade, No history of susceptibility to the drugs studied (so that patients are asked about drug sensitivities prior to entering the study and if they have not a history of hypersensitivity, they are included in the study, Signing consent form informed

Exclusion criteria

Exclusion criteria: Patient withdrawal criteria from the study include: Pregnant women who recently used (3 weeks) vitamin E and other supplemental antioxidants, Patients with other active oral lesions (such as major asthma), History of alcohol use, Drugs - Performing previous radiotherapy treatments and current chemotherapy treatments and bone marrow transplants with clinical, neurological, endocrine and other systemic diseases. Karnofsky performance status scale less than 60 (Patients in need of admission)

Design outcomes

Primary

MeasureTime frame
PAIN. Timepoint: weeks1,2,3,4. Method of measurement: Numerical pain scale.;The rate of improvement in the severity of oral lesions. Timepoint: possible change of oral mucositis grade from 3 and 4 to steady levels. Method of measurement: WHO Grading.;Type of prescription. Timepoint: weeks 1,2,3,4. Method of measurement: Based on the study method.;Period of time. Timepoint: Date of referral of patients in weeks 1, 2, 3 and4. Method of measurement: Week 1 and 2, 3, and 4 Treatments.;Gender. Timepoint: Date of referral of patients. Method of measurement: observation.;Age. Timepoint: Date of referral of patients. Method of measurement: Ask the patient.

Secondary

MeasureTime frame
Lack of the mouth wash tolerance is noted by patients and the study will be stopped if there are significant numbers of these people. Timepoint: weeks 1,2,3,4. Method of measurement: ask the patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFARZANEH AGHAHOSSEINI

Tehran University of Medical Sciences

dentistry@tums.ac.ir+98 21 8801 5950

Outcome results

None listed

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