Comparable efficacy of extraoral and intraoral photobiomodulation in preventing oral mucositis during high-dose methotrexate therapy in pediatric oncology: A single-blind randomized controlled trial.
4 affiliations
- 1Department of Stomatology, Federal University of Paraná (UFPR), Curitiba, Paraná, Brazil. [email protected].
- 2Department of Stomatology, Federal University of Paraná (UFPR), Curitiba, Paraná, Brazil.
- 3Hospital Erasto Gaertner, Curitiba, Paraná, Brazil.
- 4National Institute of Science and Technology in Translational Biophotonics in Dentistry, INCT-BIOFOTO BUCAL, Porto Alegre, Brazil.
Abstract
Purpose
This prospective randomized controlled clinical study compared intraoral (IO) and extraoral (EO) photobiomodulation (PBM) for the prevention of chemotherapy-induced oral mucositis (OM) in pediatric oncology patients.Methods
A total of 155 patients (1-18 years), receiving high-dose methotrexate (HDMTX) for leukemia, lymphoma, or osteosarcoma, were randomized to PBM-IO (n = 73) or PBM-EO (n = 82). Preventive PBM was administered daily from hospital admission through discharge. Both protocols used red light with equivalent dosimetry (660 nm, 100 mW, 1 J per point). PBM-EO required 30 s/session, whereas PBM-IO required approximately 6 min, excluding patient handling time. OM occurrence, severity (WHO scale), plaque index, and pain (numeric rating scale) were assessed on days 0, 3, 5, and 10 after HDMTX infusion.Results
The overall OM occurrence was 35.5%, with no significant difference between PBM-IO (41.1%) and PBM-EO (30.5%) groups (p = 0.168). No statistically significant differences were observed between groups for OM severity, pain, salivary pH, or plaque index at any time point (p > 0.05). Multivariable ordinal logistic regression demonstrated that PBM modality was not independently associated with OM severity. As expected, increasing age (OR = 1.14; 95% CI: 1.04-1.25; p = 0.004) and higher HDMTX dose (OR = 1.24; 95% CI: 1.03-1.49; p = 0.021) were significantly associated with greater OM severity. Median pain scores remained 0 at all assessment points in both groups.Conclusion
Extraoral PBM demonstrated comparable effectiveness to intraoral for OM prevention in pediatric patients undergoing HDMTX chemotherapy, while reducing application time.
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BibTeX
@article{freitas2026comparable,
title = {{Comparable efficacy of extraoral and intraoral photobiomodulation in preventing oral mucositis during high-dose methotrexate therapy in pediatric oncology: A single-blind randomized controlled trial.}},
author = {Isabela de Oliveira Plugge Freitas and Isabela Schuartz and Giovanna Leal Klein Renz and Rafael Zancan Mobile and Mariana Lena Sassi França and Mara Albonei Dudeque Pianovski and Laurindo Moacir Sassi and Melissa Rodrigues de Araujo},
journal = {Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer},
year = {2026},
month = oct,
doi = {10.1007/s00520-026-11372-9},
url = {https://europepmc.org/article/MED/42897331},
note = {CC BY},
}
RIS
TY - JOUR
TI - Comparable efficacy of extraoral and intraoral photobiomodulation in preventing oral mucositis during high-dose methotrexate therapy in pediatric oncology: A single-blind randomized controlled trial.
AU - Isabela de Oliveira Plugge Freitas
AU - Isabela Schuartz
AU - Giovanna Leal Klein Renz
AU - Rafael Zancan Mobile
AU - Mariana Lena Sassi França
AU - Mara Albonei Dudeque Pianovski
AU - Laurindo Moacir Sassi
AU - Melissa Rodrigues de Araujo
PY - 2026
DA - 2026/10/19
JO - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
DO - 10.1007/s00520-026-11372-9
UR - https://europepmc.org/article/MED/42897331
AB - Purpose This prospective randomized controlled clinical study compared intraoral (IO) and extraoral (EO) photobiomodulation (PBM) for the prevention of chemotherapy-induced oral mucositis (OM) in pediatric oncology patients.Methods A total of 155 patients (1-18 years), receiving high-dose methotrexate (HDMTX) for leukemia, lymphoma, or osteosarcoma, were randomized to PBM-IO (n = 73) or PBM-EO (n = 82). Preventive PBM was administered daily from hospital admission through discharge. Both protocols used red light with equivalent dosimetry (660 nm, 100 mW, 1 J per point). PBM-EO required 30 s/session, whereas PBM-IO required approximately 6 min, excluding patient handling time. OM occurrence, severity (WHO scale), plaque index, and pain (numeric rating scale) were assessed on days 0, 3, 5, and 10 after HDMTX infusion.Results The overall OM occurrence was 35.5%, with no significant difference between PBM-IO (41.1%) and PBM-EO (30.5%) groups (p = 0.168). No statistically significant differences were observed between groups for OM severity, pain, salivary pH, or plaque index at any time point (p > 0.05). Multivariable ordinal logistic regression demonstrated that PBM modality was not independently associated with OM severity. As expected, increasing age (OR = 1.14; 95% CI: 1.04-1.25; p = 0.004) and higher HDMTX dose (OR = 1.24; 95% CI: 1.03-1.49; p = 0.021) were significantly associated with greater OM severity. Median pain scores remained 0 at all assessment points in both groups.Conclusion Extraoral PBM demonstrated comparable effectiveness to intraoral for OM prevention in pediatric patients undergoing HDMTX chemotherapy, while reducing application time.
SN - 0941-4355
SN - 1433-7339
ER -