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Low-level laser therapy versus herbal mouth wash in the management of radiation induced oral mucositis

Comparative efficacy of low-level laser therapy versus herbal mouth wash in the management of radiation induced oral mucositis-A randomized controlled clinical single -blinded study . - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088696
Enrollment
75
Registered
2025-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K123- Oral mucositis (ulcerative)

Interventions

Intervention1: Participants undergoing low level laser therapy with radiation induced oral mucositis: 25 participants will be submitted to low level laser therapy (Diode laser) twice a week, during t

Sponsors

Vaishnavi Kabra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Both male and female patients aged above 18 years will be included in the study. Participants with histopathologically proven head and neck carcinoma scheduled to undergo radiotherapy involving at least two third of oral cavity in radiation field.

Exclusion criteria

Exclusion criteria: 1.Participants who do not wish to participate or refuse to give a written consent for the study will be excluded from the study. 2.Patients receiving induction chemotherapy or receiving concurrent chemotherapy for treatment of head and neck carcinoma 3. Patients undergoing palliative therapy, short duration radiotherapy will be excluded 4. Patients were excluded if they had lock jaw, any medical condition affecting healing mechanisms (like diabetes), prior radiation for head and neck carcinoma, were receiving any chemo-sensitizer and were not receiving high dose radiation to oral cavity region. 5.Patients allergic to the ingredients of mouthwash. 6.Elderly patients with morbidity, pregnant and lactating females

Design outcomes

Primary

MeasureTime frame
To assess and compare the intensity and duration of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group by World Health organization (WHO) scale and Oral Mucositis Assessment Scale (OMAS). To assess and compare the maximum pain score by visual analog scale of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group. Timepoint: Baseline, 3rd week and 6th week.

Secondary

MeasureTime frame
To evaluate quality of life by European organisation for research and treatment of cancer (EORTC QLQ) questionnaire in participants before and after treatment of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group To assess the incidence of supplemental nutrition through feeding tube between low level laser therapy, polyherbal mouth wash and placebo group To assess body weight loss between low level laser therapy, polyherbal mouth wash and placebo group To assess incidence and duration of radiation therapy interruption if any between low level laser therapy, polyherbal mouth wash and placebo group. Timepoint: 2nd week to sixth week

Countries

India

Contacts

Public ContactVaishnavi Kabra

K M Shah Dental College and Hospital

iafdeepa@gmail.com9145184941

Outcome results

None listed

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