Effects of Photobiomodulation Conditioning in Impacted Third Molars
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The removal of third molars should be considered to avoid problems such as cysts and other
      complications. Surgical intervention with the manipulation of oral tissues has the
      undesirable postoperative effects of pain, trismus (limited mouth opening) and edema.
      Photobiomodulation has also proved effective regarding reductions in pain, edema and trismus.
      The aim of the present study was to evaluate the effectiveness of photobiomodulation for the
      conditioning of tissues involved in the surgical removal of impacted mandibular third molars
      in terms of reducing or eliminating postoperative pain, trismus and edema.
    

Detailed description: 
      The investigator will select 62 patients from Nove de Julho Clinics, minimal 18 years old,
      with impacted third molar teeth. The volunteers will be randomly allocated to two groups
      using a block randomization process: photobiomodulation group (PG) and sham group (SG). The
      same surgeon and assistant performed all operations. The surgeon, assistant and patients will
      be all blinded to the LED treatment protocol. The participants in the active
      photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm 08J
      80 seconds perpendicular to the surface of the skin in gentle stationary contact at three
      extraoral points. For the participants in the sham group, a device with a similar appearance
      will be used that did not emit radiation. Treatment will be administered one hour prior to
      the surgical procedure as well as 48 hours and seven days (removal of sutures) after the
      first irradiation. The visual analog scale will be used for the measurement of pain
      intensity, facial measurements evaluated edema. Mouth opening range will be measured with
      sterilized manual calipers between the incisal edge of the maxillary and mandibular central
      incisors. The distribution of the data (normal or non-normal) will be determined using the
      Shapiro-Wilks test. Data with normal distribution will be analyzed using two-way
      repeated-measures analysis of variance (ANOVA), the t-test for two groups with independent
      measures and the paired t-test for two groups with dependent measures. Data with non-normal
      distribution will be analyzed using the Wilcoxon test for paired data and the Mann-Whitney
      test for independent data. Categorical data will be analyzed using Fisher's exact test for
      independent data and McNemar's test for paired data. The significance level will be set at α
      = 0.05.
    

Intervention name(s): Infrared LED; Similar device - Infrared ED
Intervention type(s): Device; Device
Intervention description(s): The participants in the active photobiomodulation group will be irradiated with infrared LED at a wavelength of 850 nm perpendicular to the surface of the skin in gentle stationary contact at three extraoral points. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation.; For the participants in the sham group, a device with a similar appearance will be used that did not emit radiation. Treatment will be administered one hour prior to the surgical procedure as well as 48 hours and seven days (removal of sutures) after the first irradiation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention