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Phenytoin Mucoadehesive Tablet versus Mouthwash in treatment of Oral Mucositis

Efficacy of Phenytoin mucoadhesive tablet versus mouthwash on chemotherapy induced oral mucositis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20130521013406N5
Enrollment
40
Registered
2019-07-07
Start date
2014-04-21
Completion date
Unknown
Last updated
2019-10-07

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

Conditions

chemotherapy induced oral mucositis. Oral mucositis (ulcerative) due to antineoplastic therapy

Interventions

Intervention 1: Intervention group: phenytoin mucoadhesive tablet Mucoadhesive tablets are prepared by direct compression method. The ingredients (10 mg sodium phenytoin and the rem
NaCMC, 25:25:50 w/w %) are weighed accurately and mixed by trituration in a mortar by pestle for 15 minutes. Then all of the ingredients are passed through sieve no. 100. Finally the mixture is compre

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh Rezazadeh

Shiraz University of Medical Sciences

Rezazadehf@sums.ac.ir+98 71 3230 5410

Outcome results

None listed

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