Phenytoin Mucoadehesive Tablet versus Mouthwash in treatment of Oral Mucositis

Phase 2

• Conditions: chemotherapy induced oral mucositis.; Oral mucositis (ulcerative) due to antineoplastic therapy; K12.31

• Registration Number: IRCT20130521013406N5
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

patients underwent chemotherapy process, due to various types of malignancies, without concurrent radiotherapy
mucositis grade 2 or 3 (WHO criteria)
prognosis for at least 6 months
signing the consent form

Exclusion Criteria

Patients with mucositis of grade 1 or 4
sign of causing side effects (such as sensitivity to phenytoin)
lack of patient cooperation or trend to complete the treatment process
systemic diseases with oral mucositis (such as connective tissue diseases and Sjogren syndrome)or interfering with healing process of tissues (such as diabetes)
smoking and alcohol consumption

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Grade of oral mucositis and pain. Timepoint: before intervention, 1 and 2 weeks after intervention. Method of measurement: WHO grading and Visual analogue scale.