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This study is blind, randomized controlled and have been carried out on children between 6 and 9 years of age, at the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, and surrounding schools. Patients who present temporomandibular disorders, based on the diagnostic criteria will be the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) were included. The laser used was infrared, power 100 mW ±20%, wavelength 660nm ±10 nm, energy parameter 60J, continuous application. The technique is not invasive, the irradiation point is by continuous and direct transcutaneous application to the radial artery by means of a bracelet that inserts the laser beam. One session has been performed. There was a laser group, a placebo group. Participants in all groups were re-evaluated after the procedure, following the same evaluation procedures used initially, evaluating the effects of ILIB on pain and range of motion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VPBM group (vascular photobiomodulation) | Active Comparator | The participants received a single session of VPBM. |
|
| Sham group (simulated vascular photobiomodulation) | Placebo Comparator | The participants received the same treatment as the VPBM group, but the equipment was switched off. To ensure blinding, the sound of the device (beep) was activated at the time of simulated PBM using a telephone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascular photobiomodulation (VPBM) | Radiation | The participants received a 20-minute single session of VPBM. This noninvasive method involves the use of low-power laser coupled to a bracelet designed to transport the light beam transcutaneously over the radial artery. The laser device (DMC Therapy Ec) delivered irradiation with a power of 100 ± 20 mW, wavelength of 660 ± 10 nm (red light) and energy of 120 J applied continuously, with irradiance of 35 W/cm². |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mouth opening range of motion (following clinical protocol of DC/TMD) | Vertical movement of the jaw was measured using calibrated digital calipers. | Baseline and immediately after the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Pain Evaluation | Pain was assessed using the VAS, which is an instrument for the subjective assessment of pain. The subject makes a mark along a horizontal line with 0 (absence of pain) printed at one end and 10 (extreme pain) printed at the other end. The patient's mark on the line is recorded in the clinical history for reproduction among observers. | Baseline and immediately after the procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Nove de Julho | São Paulo | São Paulo | 01525-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36281107 | Derived | Sertaje MRF, Goncalves MLL, Gomes AO, Bruno LH, Fossati AL, Viarengo NO, Santos EM, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial. Medicine (Baltimore). 2022 Oct 21;101(42):e31228. doi: 10.1097/MD.0000000000031228. |
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Participants in the placeb group will be treated in the same way as the active laser group. The person in charge of the application will simulate the irradiation with the equipment kept off, so that the participant does not identify the group to which he/she belongs to, and the device activation sound (beep) will be turned on at the time of application.
|
| Sham group (simulated vascular photobiomodulation) | Radiation | Simulated radiation. The participants received a single session. |
|
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
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