- Design
- Single-blind randomised controlled trial
- Population
- 155 children aged 1–18 on high-dose methotrexate
- Primary outcome
- Occurrence and severity of oral mucositis
- Effect
- Mucositis 30.5% extraoral vs 41.1% intraoral (p = 0.17)
In a single-blind randomised trial in Brazil, 155 children and adolescents receiving high-dose methotrexate for leukaemia, lymphoma or osteosarcoma had daily preventive photobiomodulation with red light, applied either inside the mouth (about six minutes a session) or on the skin over the oral structures (30 seconds), at equivalent doses.
Oral mucositis occurred in 41.1% with intraoral and 30.5% with extraoral treatment (p = 0.17), with no difference in severity, pain, plaque or salivary pH. Older age and higher methotrexate dose were associated with more severe mucositis. Median pain scores were zero throughout in both groups.
There was no untreated control, so the trial compares two methods rather than testing photobiomodulation itself. Where units already use it, the extraoral approach is faster, easier for young children to tolerate and frees staff time.
- Consider extraoral photobiomodulation where the unit already offers intraoral treatment.
- Expect more mucositis in older children and at higher methotrexate doses.
- Keep basic oral care — brushing, rinsing and dental review — alongside any light therapy.
- Assess mucositis and pain on a scheduled basis after each high-dose cycle.
Why it matters
A six-minute intraoral procedure on a distressed child is a barrier; a 30-second external one is not.
Don't overread it
The trial was not designed to prove equivalence, and it had no untreated comparison group.
The statistics, in plain English
A p value of 0.17 means the difference between 41% and 31% could plausibly be chance. That does not prove the methods are equal; a trial built for equivalence would need a pre-set margin.
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