Extraoral Versus Intraoral Photobiomodulation for the Prevention of Oral Mucositis in Pediatric Patients Undergoing High-Dose Methotrexate Chemotherapy.
Mariana Lena Sassi, Nicoly Ghilardi Cardoso, Rafael Zancan Mobile et al.
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In 30 seconds
This prospective, open-label randomized clinical trial compared intraoral (IO) with extraoral (EO) red-light photobiomodulation for preventing oral mucositis in children aged 1–18 years receiving high-dose methotrexate. Across 75 treatment episodes in 31 patients, cumulative mucositis occurred in 22/37 IO episodes (59.5%) and 12/38 EO episodes (31.6%). Accounting for repeated episodes within patients, mucositis risk was higher with IO-PBMT (risk ratio, 1.84; 95% CI, 1.07-3.19; p = 0.029). EO-PBMT also took less application time; pain, salivary measures, and biochemical profiles did not differ significantly.
Key findings
- Cumulative oral mucositis occurred in 22/37 IO-PBMT episodes (59.5%) versus 12/38 EO-PBMT episodes (31.6%).
- After accounting for repeated episodes within patients, mucositis risk was higher with IO-PBMT (risk ratio, 1.84; 95% CI, 1.07-3.19; p = 0.029).
- EO-PBMT required substantially less application time, and no adverse effects were reported.
- Pain scores, salivary pH, and salivary biochemical profiles did not differ significantly between groups.
Why it matters
Oral mucositis is a relevant complication during high-dose methotrexate treatment in children. This trial suggests that the extraoral delivery approach may reduce its occurrence while requiring less application time, without reported adverse effects. The findings offer comparative evidence on delivery method, although they do not establish effects beyond the studied treatment episodes and population.
What to keep in mind
The trial was open-label and included 31 patients, with 75 treatment episodes; repeated episodes within patients required statistical adjustment. Follow-up assessments were limited to days 3, 5, and 10.