Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy

NACompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

February 14, 2017

Study Completion Date

February 14, 2017

Conditions
Oral Mucositis
Interventions
DEVICE

"Oncolase Digi therapy laser diode"

"The athermic phototherapy laser diode will be used by scanning the entire oral mucosa, including cheek and lip mucosa, gums, palate, tongue and floor of the mouth. It will be applied uniformly every two days as long as the grade of mucositis is 2 or more, with a fluence of 4J/cm², under two wavelengths (635 nm and 815 nm).~* Cheeks will be scanned extra-orally with laser fiber during 50 seconds, at the fluence of 4J/cm², associating two wavelengths : infra-red (815 nm, 3850mW) and red (635 nm, 150mW).~* Intra-orally, the fiber will be used to scan each area of mucositis during 30 seconds per area of 2 cm2, at 1cm from the mucosa; the power at 635 nm will be 150 milliwatts and 150 milliwatts at 815 nm."

Trial Locations (1)

31059

UH Toulouse, Toulouse

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER

NCT02604329 - Feasibility Study of a Protocol to Treat Pediatric Oral Mucositis by Low-level Laser Therapy | Biotech Hunter | Biotech Hunter