Facial pain
Conditions
Interventions
This is a prospective, comparative, randomized clinical trial in which 60 volunteers with signs and symptoms of Temporomandibular Joint Disorders will participate and be divided into four groups: Lase
660 nm, P = 100 mW, 3 J/point)
Laserpuncture Group – infrared light (GLIV): treatment with low-level laser (Therapy EC, DMC, São Carlos, Brazil
808 nm, P = 100 mW, 3 J/point)
Placebo Light Group (GLP): treatment with low-level laser, but with the tip protected by an optical barrier, preventing the passage of light
Traditional Acupuncture Group (GAT): treatment with sterile acupuncture needles (0.25 × 30 mm). Each group will undergo ten treatment sessions, with a seven-day interval between each session. The stud
Sponsors
Universidade Brasil
Universidade Brasil
Eligibility
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers aged between 20 and 59 years; of both sexes; with limited mouth opening or function; presence of pain in the masticatory muscles and/or temporomandibular joint (TMJ); pain during clenching or mandibular movements (muscular disorder of TMD, class Ia or Ib; or arthralgia, class IIIa), according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD); and who voluntarily agreed to participate in the study by signing the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: Volunteers who fall outside the age range established in the inclusion criteria; who have systemic disorders; who require continuous and/or frequent use of analgesics, anti-inflammatory drugs or antidepressants; who present any bone abnormality in the maxilla and/or mandible, such as TMJ arthropathy or rheumatoid arthritis; volunteers with a history of joint trauma, orthodontic treatment or who have received any form of TMD treatment in the last 6 months; pregnant women; patients with a fever on the day of attendance or thermography assessment; and volunteers who do not feel safe participating in the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes were expected. | — |
Primary
| Measure | Time frame |
|---|---|
| Outcome found 1: A significant reduction in depression and stress levels was observed in the group treated with red light only between T1 and T3, while in the group treated with infrared light the reduction occurred between T1 and T2 and also between T1 and T3. For anxiety, only the group treated with infrared light showed a statistically significant difference over time.;Expected outcome 2: It was expected to identify thermographic changes greater than 0.3 °C in the regions of interest (ROIs), suggesting a possible correlation between clinical improvement and peripheral thermal modulation.;Outcome found 2: Spot temperature variations > 0.3 °C were observed in some participants from both groups; however, these changes did not reach statistical significance (p > 0.05) between the different assessment times, indicating that the observed clinical improvement was not associated with an inflammatory process detectable by thermography.;Expected outcome 3: (Laser-needle and Placebo) The Laser-needle and Placebo groups were expected to show differences from each other and from the other groups regarding pain, depression, anxiety, and stress levels, assessed at T1, T2, and T3.;Outcome found 3: (Laser-needle and Placebo) Data collection for the Laser-needle and Placebo groups has been completed; however, the data are still being consolidated and prepared for statistical analysis. The final results will be included in the registry as soon as they are completed.;Expected outcome 1: It was expected that a reduction in depression, anxiety, and stress levels would be observed over time (T1, T2, and T3), with a more significant improvement in the group treated with infrared light, as measured by validated psychometric scales. | — |
Countries
Brazil
Contacts
Public ContactBruna Rodrigues Malho
Universidade Brasil
Outcome results
None listed