Low Level Laser Therapy Versus Benzydamin in Prevention and Treatment of Oral Mucositis

Al-Azhar University

Status and phase: Completed; Early Phase 1

Conditions: Stomatitis (Oral Mucositis)

Treatments: Device: low power laser with a wavelength of 870 nm; Drug: 0.15% bezaydamine hydrochloride.

Study type: Interventional

Funder types: Other

Identifiers

NCT05034068

Treatment of Oral Mucositis

Details and patient eligibility

About

A prospective study will be conducted at the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology Faculty of Dental Medicine, Assiut branch Al-Azhar University. Patients with head and neck cancer under RT, CT treatment participated in this study were selected from South Egypt Cancer Institute. During clinical examination the medical history of the patient will be recorded. Data related to base illness, type and stage of RT treatment, association or not to chemotherapy will be collected during the whole treatment. After clinical examination, the patients will receive a kit containing toothbrush, dentifrice, and subsequent oral hygiene instruction. Then the patients will be classified into 3 groups as follow: Group I (control group): the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. Group II: the patients will be treated by using 0.15% bezaydamine hydrochloride. All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. Group III: the patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-patients with head and neck carcinoma were scheduled to receive a RT treatment (two dimensional techniques), covering a wide area of the head and neck region, The RT protocol of the hospital for head and neck cancer patients consisted of treatment sessions 5 days a week, 2Gy per fraction, with a total dose of 70 Gy over 7 weeks (35 sessions). A minimum dose of 50 Gy was delivered to the oral cavity of all patients in the study, either exclusively or associated with chemotherapy.

Exclusion criteria

• Karnofsky performance status (KPS)less than 60% .
• Hypersensitivity to benzydamine or typical NSAIDs.
• Patients were excluded if they had lock jaw, any previous medical condition (s) hampering wound healing (e.g., diabetes mellitus).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups

control

No Intervention group

Description:

the patients will be treated by using oral care only and evaluation will be done before cancer treatment and weekly till the treatment completed. In each weekly visit, oral sites will be examined, and a score was given to each site based on the degree of mucositis.

bezaydamine hydrochloride.

Active Comparator group

Description:

All patients were advised to rinse 15 mL of the solution benzydamine for 2 min, four to eight times daily before and during, and for 2 weeks after completion of cancer therapy. In case of any problem (e.g. burning or stinging), patients will be allowed to dilute the solution with water in the ratio 1:1 or 1:2. Study evaluations will be conducted before cancer treatment and weekly thereafter until 2 weeks after completion of the therapy .In each weekly visit, oral sites were examined and a score was given to each site based on the degree of mucositis.

Treatment:

Drug: 0.15% bezaydamine hydrochloride.

low-level laser therapy

Active Comparator group

Description:

the patients will be treated by using a low-level laser therapy, the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2. The irradiations will be done intra-orally avoiding the tumor site, oral examinations will be recorded at each irradiation session and the degree of mucositis will be recorded.

Treatment:

Device: low power laser with a wavelength of 870 nm