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

Not yet recruiting

Conditions: Oral mucositis (ulcerative),

Registration Number: CTRI/2025/06/088696

Lead Sponsor: Vaishnavi Kabra

Brief Summary: Oral mucositis (OM) refers to erythematous and painful ulcerative lesions of the oral mucosa observed in patients with cancer, who are treated with chemotherapy, and/or with radiation therapy. According to the majority of studies, this complication occurs in up to 80% of patients receiving high-dose chemotherapy, and in up to 100% of patients receiving radiotherapy for head and neck cancer, and approximately 20–40% in those, who receive conventional chemotherapy.

For prevention and management of OM, it is crucial to employ an efficient compound with likely safety profile which is easy to use. Currently, commercially therapeutic mouthwashes in the market have high alcohol content, causing a burning sensation in the oral cavity. They may also cause toxicity if swallowed or consumed in excess. Herbal mouthwashes can reduce the intensity and duration of OM as well as reduce the pain scores with lesser side effects. The formulation used in the present study (Liquorice, pomegranate extract, clove oil, aloe vera and honey) has not been utilsed before and can be a novel approach for treatment of oral mucositis. Several treatment methods have been used to prevent and treat cancer therapy induced OM, but none has proven complete success against OM until date and have been performed on limited sample size. In this clinical study, we aim to evaluate the effect of the polyherbal mouthwashes in comparison to LLLT and placebo groups for prevention of radiation-induced OM. In this clinical study, we aim to evaluate the effect of the polyherbal mouthwashes in comparison to LLLT and placebo groups for prevention of radiation-induced OM.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 75

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•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).	•Baseline, 3rd week and 6th week.
•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.	•Baseline, 3rd week and 6th week.

Secondary Outcome Measures

Name	Time	Method
•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

Trial Locations

Locations (1): ]K M Shah Dental College and Hospital and SBKS Medical Institute and research centre
🇮🇳
Vadodara, GUJARAT, India
]K M Shah Dental College and Hospital and SBKS Medical Institute and research centre
🇮🇳Vadodara, GUJARAT, India
Vaishnavi Kabra
Principal investigator
09145184941
vaishukabra301@gmail.com