Clinical trial to evaluate the effectiveness and safety of the laser to control the pain caused by orthodontic treatment

INTERVENTION: 60 orthodontic patients were randomly assigned to two groups of 30 individuals per group (ages 12‐25 years with an average of 17.1 for group A; ages 12‐26 years with an average of 17.9 for group B). The patients received elastomeric separators on the mesial and distal surfaces of one of the lower first molars, and immediately after insertion of the separators, the volunteers received irradiation as randomly indicated. In addition to laser emission, the device was capable of emitting placebo light, without either the operator or the patient being aware of the type of emission (laser or placebo light). The experimental group received irradiation with LLLT, from an aluminum gallium arsenide diode, consisting of application of a single spot in the region of the radicular apex at a dose of 2 J/cm2 and application along the radicular axis of the buccal surface with three spots of 1 J/cm2 (wavelength 830 nm; infrared). The control group received irradiation with the placebo light, as a single spot application in the region of the radicular apex and as three spots along the radicular axis, for the vestibular side. For both groups, a signal was sounded at the start and end of each spot application. All the patients received a questionnaire to be filled out at home describing their levels of pain over the next five days, in situations of both a relaxed and an occluded mouth.Pain intensity was reported by patients 2, 6 and 24 hours and 3 and 5 days after placement of orthodontic separators. device E02.594.540 E06.658.453 CONDITION: dental malocclusion ; E06.658.453 ; K07.2 E06.658.453 PRIMARY OUTCOME: The volunteers received a questionnaire asking about pain intensity, to be defined on a visual analogue scale, which they filled out during the days of the week subsequent to the procedure. The patients marked the pain intensity in situations with a relaxed mouth (spontaneous pain) and upon biting only with the posterior teeth (in occlusion). The intensity of pain was reported by the patients 2, 6 and 24 hours and 3 and 5 days after orthodontic separator placement. INCLUSION CRITERIA: Chronological age greater than 12 years; Presence of erupted permanent first and second lower molars; Presence of erupted first and second premolars; Voluntary participation in the study confirmed by signing the informed consent form.