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PDT (photosensitizer and low level laser) and low level laser

Photosensitizer: aqueous solution of 0.005% methylene blue; Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)

Low level laser: infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium) and red emitter with active medium InGaAlP (phosphide and Indium, Gallium and Potassium)

Two days before the laser treatment, the side of the oral cavity chosen for the experimental treatment was pigmented with aqueous solution of 0.005% methylene blue. A ball of sterile cotton was soaked in the dye solution and placed in the center of the lesion. Photosensitizer remained in the place for 5 minutes (pre-irradiation period). Then, to activate the dye, the lesion was irradiated with red light (InGaAlP / phosphide and Indium, Gallium and potassium).

From the 3rd to the 10th day was carried out only laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium).

PDT + Low level laser

Two days before the laser treatment, the lesion of the side of the oral cavity chosen for the control treatment was treated with ball of sterile cotton soaked in distilled water and the laser unit placed on the lesion without activation of the light. From the 3rd to the 10th day was carried out laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium).

Low level laser

Meire C. Ferreira, PhD

The aim of the study was to evaluate the therapeutic action through the diameter of the lesion, of low level laser (LLL) associated to photodynamic therapy (PDT) in oral mucositis (OM) lesions, in young patients. A randomized clinical trial blinded, split-mouth was performed. The study sample consisted of 15 cancer patients (3-16 years old) of Aldenora Bello Hospital (São Luís, Maranhão, Brazil). Random allocation by lot of treatments (PDT + LLL and LLL) to quadrants of the oral cavity was performed, and the patient was his own control. Patients were masked about therapy performed on each side of the arch. The evaluation period of both therapeutic regimens was 8 days, and the outcome assessed was the lesion size (measured in cm²). Friedman and Wilcoxon tests were applied and the effect magnitude calculated. The significance level was 5%. Statistically significant difference was observed between the groups for the lesion diameter of the 6th to the 8th day (greater regression of lesion size for the PDT + LLL group), which was confirmed by a difference magnitude moderated. Based on the findings, it is concluded that PDT + LLL showed greater therapeutic effect when compared to LLL in reducing the severity of OM lesions.

The blind randomized clinical trial included 18 young patients, between 3 and 16 years old, undergoing chemotherapy or chemo/radiological the pediatric ward of Aldenora Bello Hospital in São Luís (Maranhão, Brazil). The study was conducted from October/2014 to January/2015. It was adopted as inclusion criteria patients between 3 and 18 years old, in the inductive phase of chemotherapy, with oral mucositis (OM) and bilateral lesions.

A mouth split model was conducted, and the patients were their own controls. The entry of the patients in the study occurred consecutively. To each patient, the operator/examiner drafted an envelope containing treatments to either side, being masked patient about the treatment of each side: PDT (photosensitized and low level laser) + low level laser; Low level laser\].

The following parameters were used for the calculation of sample size: 95% confidence level, 80% statistical power and minimal difference of 0.82 point in the lesions diameter detected between paired samples. A "n" sample minimum of 14 was determined for each treatment. In order to compensate for possible losses, 18 patients were treated.

The treatments (PDT and low level laser; Low level laser) were performed in a hospital bed. Prior to treatment, the OM lesions were evaluated and a lesion on each side was chosen. Lesions should be located at the same site on both sides. The chosen site was the lip mucosa. Before the procedure, the patient was instructed as to brushing and not using mouthwashes, followed by cleaning of the oral cavity with gauze and distilled water. Two days before the laser treatment, the side of the oral cavity chosen for the experimental treatment (PDT and low level laser) was pigmented with the photosensitizer (aqueous solution of 0.005% methylene blue). A ball of sterile cotton was soaked in the dye solution and placed in the center of the lesion. Photosensitizer remained in the place for 5 minutes (pre-irradiation period). Then, to activate the dye, the lesion was irradiated with red light (InGaAlP / phosphide and Indium, Gallium and potassium) (Flash Laser III, DMC, São Carlos, São Paulo, Brazil), with a wavelength of 660 nm, for a period 90 seconds, with a power of 100mW, to 1cm away, according to the manufacturer's specifications. The lesion on the opposite side was treated with ball of sterile cotton soaked in distilled water and the laser unit placed on the lesion without activation of the light. This procedure aimed to mask the patient about the side that received the experimental therapy (PDT and low level laser). This masking was possible because the experimental solution is insipid, very soluble and thus leaves no residue.

From the 3rd to the 10th day (total of 8 days) was carried out only laser therapy on both sides. Lesions were evaluated until the 8th day. After the 8th day of assessment, the lesions were only treated to a complete remission as well as other lesions present in the oral cavity. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium), with wavelength of 808nm, for analgesia. Then, the investigators used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium), with wavelength of 660nm to photobiomodulation. For both units emitting laser, the tip of the device was closed against the edges of the lesion, perpendicular to the tissue. A irradiation was continuous and the application punctual (10 seconds). The distance between the points of irradiation was about 1cm. The energy delivered was 4J per point of application. The interval between sessions was 24 hours.

The tip of the laser was disinfected with 70% alcohol solution and wrapped with a plastic film. Patients and operators wore glasses for eye protection.

A questionnaire containing demographic, socioeconomic and type of treatment for cancer was applied to parents and children. White blood cell count and platelets (beginning and end of the inductive phase of QT) were extracted from medical records.

The assessed outcome measure was the diameter of the lesion (in cm2). The areas of the lesions were measured with a flexible ruler (record made in cm2) by the operator/examiner from the start of treatment with exclusive laser therapy (3rd day). This procedure was repeated on subsequent days until the 8th day of laser treatment. The measurement of the lesions occurred prior to laser therapy applications.

The Friedman test was used for multiple comparisons within groups (different times of treatment). Paired evaluation between each two moments was evaluated using the Wilcoxon test, with significance corrected by Bonferroni test (p = 0.0071). The Wilcoxon test was used to compare the diameter of the lesion, every day, between the PDT + Low level laser and Low level laser groups (dependent samples/split-mouth). It calculated the effect magnitude (d) of standardized differences between averages of two groups. The level of significance for analysis was 5%.

Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy

Laser Therapy Associated With Photodynamic Therapy in the Treatment of Oral Mucositis Induced by Chemotherapy in Young Patients: Randomized Blind Clinical Trial

Fundação de Amparo à Pesquisa e Desenvolvimento Científico do Maranhão

Universidade Ceuma

Matheus Coelho Bandeca

Neoplasms

Head and Neck Neoplasms

Xerostomia

Salivary Gland Diseases

Anticoagulants

Bone Density Conservation Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Calcium

Calcium, Dietary

Chelating Agents

Citrate

Laser group composes of thirty patients who will receive low level laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions

control group composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec

Laser will be performed with a GaAlAs diode laser at a wavelength of 808 nm, 100-mW output power, laser beam area of 0.03 cm2, and in continuous wave mode, three times a week, on alternate days. Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions.

The total energy per session (56 J) will be divided into 14 irradiation points, as marked on the overlying skin (Fig.2). Each irradiation point received a dose of 4 J over an irradiation time of 40 s.

With exclusion of tumor area or area of removed tumor laser will be applied as following:

• Extra oral application: The laser will be used extraorally at eight points in the parotid glands (bilaterally, four points in each gland), at four points in the submandibular glands (bilaterally, two points in each gland

• Intraoral application: The will be used intraorally at two points in the sublingual glands bilaterally, one point in each gland .

low level laser

citric acid solution applied as a mouth rinse

citric acid solution

Nada M. Yousef, master

Mohamed M. Mosaad, bachelor

The purpose of the study is to evaluate the effectiveness of low level laser on radiotherapy induced xerostomia to improve oral function and decrease oral complication due to hyposalivation and thus enhancing survival.

In this part of the study, the materials and methods will be presented under the following headings: subjects, equipment, procedures of the study and the statistical procedures.

1. Subjects:

   Sixty patients who have head and neck cancer (oral cavity, pharynx, larynx, or occult primary tumor) submitted to conventional 3D radiotherapy, with irradiation fields necessarily encompassing all major salivary glands. The total dose ranged from 66 to 70 Gy, given in fractions of 2 Gy/day selected randomly from Nuclear medicine department, Oncology institute, Mansoura University.

   These patients will be divided randomly into two groups of equal number, thirty patients for each group.

   Group A: (Laser group) This group of patients composes of thirty patients who will receive GaAlAs laser three times a week, on alternate day (48h interval) Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions (Fernanda A. S.G. et al., 2016).

   Group B :( Control group) This group of patients composes of thirty patients will be treated with 15mL of a 2% citric acid solution applied as a mouth rinse for 30 sec (Bozana Loncar, D.M.D. et al., 2010) .

   The criteria of Patients selection :
2. Equipment used:

1-Therapeutic equipment: Laser therapy will be performed with an GaAlAs laser

2- Evaluation tools:

* Unstimulated and stimulated saivery flow rate.
* Salivery immunoglobin A (sIgA) concentration in unstimulated saliva
* The 11-item modified Xerostomia Inventory-Dutch questionnaire version 22.

In the study, 2 groups of patients will participate First, study group will recieve low level laser on major salivary glands and usual medications.

Second, control group will recieve usual medications. Second, control

The participants are head and neck cancer patients recieving radiotherapy. The care provider are oncologist and nursing stuff. The investigator is phsical therapist (my self)

Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.

The XI is an 11-item summated rating scale that was developed to measure the severity of dry mouth symptoms. The final score ranges from 5 to 55, with higher scores indicating more severe symptoms. A decrease in XI scores of 6 points or more between pre- and post-treatment assessments will be considered clinically significant.

The mean dry mouth score and the correlation between dry mouth score and salivary flow rate will be analysed.

For the assessment of salivary flow rate, unstimulated and stimulated sialometry tests will be performed before the first radiotherapy session and after completion of laser programe.

As salivary secretion fluctuates between minimal and maximal rates during the day, it is important to assess the salivary secretion consistently at an established time of the day, in order to properly examine the evolution of the condition and its treatment in every patient.

The normal flow rate for unstimulated, "resting" whole saliva is 0.3 to 0.5 ml/min.; for stimulated saliva, 1 to 2 ml/min. Values less than 0.1 ml/min. are typically considered xerostomic, although reduced flow may not always be associated with complaints of dryness

The samples of unstimulated whole saliva will be frozen and stored at -20°C until used for sIgA determination. sIgA concentrations were measured by using commercially available indirect competitive enzyme immunoassay kit (Salivary SIgA EIA kit, Salimetrics).

The quantities of salivary IgA secreted in 5 minutes will be calculated by taking in account sIgA concentrations and volumes of unstimulated saliva secreted in 5 minutes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy	NCT02555501	Oral Mucositis	PDT + Low level... Low level laser	3 Years - 18 Years	Universidade Ceuma
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.	NCT04700475	Head and Neck C...	low level laser citric acid sol...	25 Years - 55 Years	Cairo University
Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy	NCT02555501	Oral Mucositis	PDT + Low level... Low level laser	3 Years - 18 Years	Universidade Ceuma
Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy	NCT02555501	Oral Mucositis	PDT + Low level... Low level laser	3 Years - 18 Years	Universidade Ceuma

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