Trigeminal Nerve Diseases
Conditions
Interventions
In this triple-blind randomized clinical trial, 80 volunteers referred to the Special Laboratory for Lasers in Dentistry with an indication for trigeminal neuralgia treatment will be selected, regardl
the application will be performed using the DMC e-light IL device with 8 laser diode emitters, with an infrared wavelength (808 nm), power of 120 mW, and 4 J of energy per extraoral point along the en
the protocol will consist of two sham laser applications per week for one month, with a minimum interval of 48 hours. At the end of the eighth session, the participant will be reassessed. To ensure me
the professionals responsible for the laser application will be unaware of whether the device is active or placebo (sham)
and the clinical evaluators will have no knowle
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria: individuals aged 18 years or older; of both sexes; regardless of ethnicity or socioeconomic status; diagnosis of trigeminal neuralgia confirmed by a neurologist; and signing of the informed consent form
Exclusion criteria
Exclusion criteria: Exclusion criteria include: participants with an inconclusive diagnosis of trigeminal neuralgia or those without prior evaluation by a neurologist; individuals with a history of other facial neuropathies; those who have undergone laser therapy within the last 3 months; and individuals over 80 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study expects to find a significant reduction in trigeminal neuropathic pain intensity in the active photobiomodulation group compared to the placebo group. This change will be verified using the Visual Analog Scale (VAS), where patients rate their discomfort from 0 to 10, and the OHIP-14 questionnaire, which consists of 14 questions regarding the volunteer's quality of life (with responses ranging from 0 – never, 1 – rarely, 2 – sometimes, 3 – often, to 4 – always). These assessments will be administered before the start of the protocol and after the eighth session | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactLuciane Azevedo
Universidade de São Paulo
Outcome results
None listed