Comparison of different mouth rinse for oral ulcer in head & neck cancer patients

Comparative Evaluation of topical application of lignocaine based mouth rinse with dexamethasone based mouth rinse for oral mucositis in patients of head and neck cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/022824

Enrollment

Registered

2020-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: dexamethasone based mouth rinse: use of dexamethasone based mouth rinse(0.1 mg/ml dexamethasone in boroglycerine) in management of oral mucositis in head & neck cancer patients Control

Eligibility

Inclusion criteria

Inclusion criteria: Head and neck cancer patients with oral mucositis ( World Health Organization grade 1-4)

Exclusion criteria

Exclusion criteria: . Patients with severe renal or hepatic insufficiency . Patients with collagen vascular disorder . Patients allergy to any ingredient of the mouth rinse . Pregnancy . Patients with active oral infection requiring antibiotics/antifungals

Design outcomes

Primary

Measure	Time frame
Analgesic efficacy in terms of improvement in pain scores and doses of analgesicsTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week	—

Secondary

Measure	Time frame
Duration of pain relief following the use of different mouth rinseTimepoint: duration 30 minutes, 30 mins-1 hr or 1 hr;WHO grading of mucositisTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;different side effectsTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;ECOG scoreTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;Patient satisfaction scoresTimepoint: 4th week;Functional impairment scale(FIS)Timepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week	—

Measure

Time frame

Duration of pain relief following the use of different mouth rinseTimepoint: duration 30 minutes, 30 mins-1 hr or 1 hr;WHO grading of mucositisTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;different side effectsTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;ECOG scoreTimepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week;Patient satisfaction scoresTimepoint: 4th week;Functional impairment scale(FIS)Timepoint: 1st day, 3rd day, 1st, 2nd, 3rd and 4th week

—

Countries

India

Contacts

Public ContactDimple Pangtey

VMMC and Safdarjung Hospital

truegemini21@gmail.com9868435534

Outcome results

None listed

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