Effectiveness of Extraoral Photobiomodulation in Management of Oral Adverse Effects in Patients Undergoing HSCT
Oral Mucositis, Hematopoietic Neoplasm, Xerostomia
About this trial
This is an interventional prevention trial for Oral Mucositis
Eligibility Criteria
Inclusion Criteria: Patients aged 18 and scheduled for autologous or allogeneic HSCT. Patients undergoing myeloablative conditioning regimen Exclusion Criteria: Patients previously submitted to autologous or allogeneic HSCT Patients on a non-myeloablative conditioning regimen Patients on a reduced-intensity conditioning regimen
Sites / Locations
- Federal University of Rio Grande do SulRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Intraoral photobiomodulation (PBMI)
Extraoral photobiomodulation (PBME)
The protocol will be performed daily by a single trained professional from the first day of conditioning until D + 5 after bone marrow transplantation or while lesions are present. PBMI protocol will use the indium-gallium-aluminium-phosphorus diode laser (InGaAlP) (DUO® - MMOptics Ltda, São Carlos, Brazil). Four anatomical areas will be irradiated perpendicularly in the buccal mucosa through several anatomical points with a distance of approximately 1 cm between them, in order to cover the largest area per cm² by region. Application points: Buccal mucosa: 9 points each side: bite line on cheeks and upper and lower internal buccal vestibule (18 points). Tongue: 4 points on each side, on the lateral and ventral edge (8 points). Floor of the mouth: 1 point on each side (2 points) Upper and lower lips: upper and lower lips (lip redness), bottom of upper and lower sulcus and buccal commissure, right and left sides (4 points). Soft palate: right and left side (2 points)
The protocol will be performed daily by a single trained professional from the first day of conditioning until D + 5 after bone marrow transplantation or while lesions are present. A gallium-aluminum arsenide diode laser (Gemini® manufactured by Azena Medical, LLC, distributed by Ultradent Products, Inc.) with double wavelength 810 + 980 nm, previously standardized and calibrated for extraoral application by the measurement of potency (Coherent Inc, Santa Clara, CA). The equipment will be programmed with 1 W of power. The application points will be carried out perpendicularly on the face. Application points: 4 points on each cheek (2 on the right and 2 on the left) 1 on lips; patients with sealed lips being possible to cover the upper and lower lip 5 points in the cervical region (2 in the right submandibular space and 2 in the left submandibular space and submental space in the midline).