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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
0.15% bezaydamine hydrochloride was applied in oral mucosa in Patients with head and neck cancer under RT, CT treatment.
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
Faculty of dental medicine Al-Azhar University (Assiut branch)
Asyut, Asyut Governorate, Egypt
TNF-α [picograms/millimeter (pg/ml)] in saliva
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify TNF-α amount in picograms.
Time frame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
IL-6 [picograms/millimeter (pg/ml)] in saliva
Unstimulated saliva (2 mL) were obtained after oral rinse with room-temperature water. It was be stored in sterile collection tubes that were labeled at - 80C. Enzyme-linked immunosorbent assays were used to quantify IL-6 amount in picograms.
Time frame: Change from Baseline (before Anti-cancer treatment) at 7 weeks (after Anti-cancer treatment)
WHO scale for severity of oral mucositis.
WHO scale scoring severity of oral mucositis by assessor as following: Score 0-no signs or symptoms. Score 1-oral soreness and erythema. Score 2-oral erythema and ulcers, both solid and liquid diets tolerated. Score3-oral ulcers, liquid diet only. Score 4-oral alimentation impossible.
Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
National Institute of the Cancer-Common Toxicity criteria (NIC-CTC) RT-induced oral mucositis scale for extent of oral mucositis.
(NIC-CTC) RT-induced oral mucositis scale scoring extension of mucositid as following: (0) patients with oral mucosa presenting no visible alteration. 1. Presence of erythema. 2. Ulcers with up to 1.5 cm diameter and noncontiguous. 3. Ulcers larger than 1.5 cm diameter and contiguous. 4. Ulcers exhibiting necrosis and bleeding. 5. Death related to toxicity
Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
visual analog scale (VAS) scale for pain assessment
The VAS was modified according to the scale proposed by Bensadoun et al. : scores 1 and 2 (mild pain) were considered grade I, scores 3 and 4 (moderate pain) were grade II, scores of 5 to 7 (severe pain) were grade III and scores of 8 to 10 (very severe pain) were grade IV.
Time frame: Change from Baseline (7 days after the beginning of Anti-cancer treatment) at 7 weeks (completion of Anti-cancer treatment)
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