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Use of LED Mask for Prevention and Treatment of Oral Mucositis

Development and Evaluation of a Protocol Using an LED Mask for extra-oral Photobiomodulation in the Prevention and Treatment of Oral Mucositis Induced by High-Dose Methotrexate

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4k23pzf
Enrollment
Unknown
Registered
2025-10-14
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Laser Therapy

Interventions

This is a randomized clinical trial in which 80 patients will be included. All participants will receive instructions on oral hygiene (including the use of a toothbrush, dental floss, and toothpaste—a
E02.594.540

Sponsors

Centro Universitário do Pará - CESUPA
Lead Sponsor
Centro Universitário do Pará - CESUPA
Collaborator

Eligibility

Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Patients aged between 6 and 18 years; of both genders; diagnosed with Acute Lymphoblastic Leukemia; undergoing Methotrexate treatment during the consolidation phase; following the Berlin-Frankfurt-Münster (BFM) 2012 protocol (5 g/m² over 24 hours by intravenous infusion), at the Oncology Department of the Octávio Lobo Children’s Oncology Hospital; patients or legal guardians who agree to and sign the Informed Consent Form

Exclusion criteria

Exclusion criteria: Presence of photosensitivity; loss of treatment follow-up; inability to complete the Visual Analogue Scale; refusal to undergo any Photobiomodulation session; and limitation in mouth opening

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Extraoral Light-Emitting Diode (LED) therapy in the prevention of Oral Mucositis associated with Methotrexate (MTX) treatment in children with Acute Lymphoblastic Leukemia (ALL).

Secondary

MeasureTime frame
To compare the efficacy of Extraoral Light-Emitting Diode (LED) therapy and Intraoral Light Amplification by Stimulated Emission of Radiation (LASER) therapy in the prevention of Oral Mucositis associated with Methotrexate (MTX) treatment in children with Acute Lymphoblastic Leukemia (ALL).

Countries

Brazil

Contacts

Public ContactGiovana Okajima Carrenho

Centro Universitário do Pará - CESUPA

giovanacarrenho@gmail.com+55 (91) 992256030

Outcome results

None listed

Source: REBEC (via WHO ICTRP)