Efficacy and safety of low-power lasers for oral mucositis

Exploratory Study of Efficacy and Safety of Diode Laser for Oral mucositis in Japanese Patients with Hematopoietic Malignancies undergoing Hematopoietic Stem Cell Transplant. An Open-Label Exploratory Study of the Efficacy of Low-Power Lasers in Reducing Chemotherapy Induced Oral mucositis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs062220069

Enrollment

Registered

2022-11-10

Start date

2022-12-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic malignancies requiring allogeneic/autologous hematopoietic stem cell transplantation

Interventions

A low-power laser (Diode Laser Sheep 810: wavelength 650 nm, power 40 mW, energy density 2 J/cm2 per 1 cm square area, 2 seconds per point) is irradiated into the patient's mouth by a dentist three ti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (i) 18 years and older (ii) Patients with hematopoietic malignancies who are scheduled for hematopoietic stem cell transplantation (not limited to first-line treatment) (iii) No oral mucositis during the previous observation period (iv) The patient must consent to the study

Exclusion criteria

Exclusion criteria: (i) Patients who have developed oral mucositis due to caries, dentures, or other irritations (ii) Patients with a history of radiation therapy to the oral cavity (iii) Other subjects deemed inappropriate by the principal investigator or subinvestigator

Design outcomes

Primary

Measure	Time frame
Percentage of patients who developed Grade 2 or higher oral mucositis according to NCI-CTCAE ver 5.0	—

Secondary

Measure	Time frame
Numerical Rating Scale(NRS) Number of days of use of mouthwash containing analgesics/local anesthetics Oral score using the Oral Environment Assessment and Oral Infection Source Risk Assessment Inflammation area of periodontal tissue by periodontal histology PISA Oral bacterial count Oral dryness (saliva test and mucus measurement) Time to first occurrence of endodontic inflammation Duration of each grade of oral mucositis Oral mucositis assessment by NCICTCAE ver5.0, Oral Mucositis Assessment Scale (OMAS) Oral flora analysis (analysis of the flora of all subjects based on the tongue) Hematological examination (white blood cell count, white blood cell fraction, red blood cell count, hemoglobin, CRP, TP, Alb), blood culture Inflammatory cytokines in saliva (IL1a,b, 6, 7, 8, 10, 18, IFNy, IP10, TNFa, VEGF, MIP1a,b)	—

Measure

Time frame

Numerical Rating Scale(NRS) Number of days of use of mouthwash containing analgesics/local anesthetics Oral score using the Oral Environment Assessment and Oral Infection Source Risk Assessment Inflammation area of periodontal tissue by periodontal histology PISA Oral bacterial count Oral dryness (saliva test and mucus measurement) Time to first occurrence of endodontic inflammation Duration of each grade of oral mucositis Oral mucositis assessment by NCICTCAE ver5.0, Oral Mucositis Assessment Scale (OMAS) Oral flora analysis (analysis of the flora of all subjects based on the tongue) Hematological examination (white blood cell count, white blood cell fraction, red blood cell count, hemoglobin, CRP, TP, Alb), blood culture Inflammatory cytokines in saliva (IL1a,b, 6, 7, 8, 10, 18, IFNy, IP10, TNFa, VEGF, MIP1a,b)

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Contacts

Public ContactHiromi Nishi

Hiroshima University Hospital

hiyoko@hiroshima-u.ac.jp+81-82-257-5744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026