title: A randomized controlled trial of visible-light therapy for the prevention of oral mucositis.
abstract: The objective of this study was to assess the efficacy of a novel visible-light therapy (VLT) device for the prevention of oral mucositis in hematopoietic stem cell transplantation (HSCT) patients. A VLT-device suitable for intra-oral use was applied to 20 patients undergoing HSCT. The study design was placebo-controlled, randomized and double-blind. Oral mucositis was assessed using the OMAS and WHO scales. Oral pain and acceptance levels were scored by the patient using a 10-step scale. Patients were evaluated once a week until day 21 post-HSCT. Mucositis rate, severity and pain score were compared. At the third visit, 1week post-HSCT, mucositis rates were significantly lower in the treatment group (for both WHO and OMAS p=0.02). Mucositis was also less severe in the treatment group (for WHO p=0.01; for OMAS p=0.01). Furthermore, the patients in the treatment group reported lower pain levels (p=0.04). The treatment was well tolerated and highly accepted, with no reports of adverse events related to the device. These findings suggest that the VLT-device is safe and effective for the prevention of oral mucositis in patients undergoing HSCT.
authors.affiliation: Department of Oral Medicine, Hebrew University - Hadassah School of Dental Medicine, Jerusalem, Israel. sharon.elad@ekmd.huji.ac.il
authors.forename: Sharon
authors.initials: S
authors.lastname: Elad
authors.forename: Noa
authors.initials: N
authors.lastname: Luboshitz-Shon
authors.forename: Tehila
authors.initials: T
authors.lastname: Cohen
authors.forename: Elad
authors.initials: E
authors.lastname: Wainchwaig
authors.forename: Michael Y
authors.initials: MY
authors.lastname: Shapira
authors.forename: Igor B
authors.initials: IB
authors.lastname: Resnick
authors.forename: Ruth
authors.initials: R
authors.lastname: Radiano
authors.forename: Rachel
authors.initials: R
authors.lastname: Lubart
authors.forename: Reuven
authors.initials: R
authors.lastname: Or
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects*; D006801:Humans; D008027:Light; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa; D052016:Mucositis / Q000209:etiology / Q000517:prevention & control*; D010147:Pain Measurement; D010789:Phototherapy / Q000295:instrumentation / Q000379:methods*; D010919:Placebos; D016896:Treatment Outcome
chemical_list: D010919:Placebos