101
Participants
Start Date
September 30, 2013
Primary Completion Date
October 31, 2015
Study Completion Date
October 31, 2015
Laser therapy
Treatment with K-Laser Cube3 during 4 consecutive days, with the following protocol: 660-970 nm wavelength, 3,2W mean power (6.4W pulsating at 50%), 3'51'' duration, 1-20000 Hz frequency, and 1 cm2 spot size. Laser application was performed all over the oral cavity.
Sham therapy
Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.
Policlinico Sant'Orsola Malpighi, Bologna
Spedali civili Ospedale dei Bambini, Brescia
"Ospedale Pediatrico Microcitemico Antonio Cao", Cagliari
Azienda Ospedaliera di Padova, Padua
Azienda Ospedaliero universitaria di Parma, Parma
Fondazione IRCCS, Policlinico San Matteo, Pavia
A.O.U. Città della Salute e della Scienza di Torino, Torino
IRCCS Burlo Garofolo, Trieste
IRCCS Burlo Garofolo
OTHER