Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders

Temporomandibular Disorder Clinical Trial

Official title:

Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders - Study Protocol For A Randomized, Controlled, Blind, Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05297604
• Other study ID #: TMDChildren
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 20, 2023
• Est. completion date: December 10, 2024

Study information

• Verified date: May 2023
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study, which will be blind, randomized controlled, will be 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) will be included. The laser to be used is 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 will be performed. There will be a laser group, a placebo group and a control group. Participants in all groups will be re-evaluated at the end, following the same evaluation procedures used initially, evaluating the effects of ILIB on pain and range of motion.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: December 10, 2024
• Est. primary completion date: June 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

Inclusion Criteria:

• have a complete dentition (except third molars);
• present mandibular deviation and/or deflection.

Exclusion Criteria:

• Patients with craniofacial anomalies, genetic syndromes since this is due to the fact that people with anomalies of this type are more likely to suffer from TMD due to other factors associated with their malformation, which would be a confounding variable for this study.
• Patients presenting occlusal changes; make use of any type of dental prosthesis; be undergoing orthodontic treatment or need orthognathic surgery or physical therapy; since it would alter the results of both diagnosis and treatment.
• Patients undergoing cancer treatment: because it is necessary that patients do not have any condition that alters their general health, since this may cause a different response to the proposed treatment.
• Patients who start using any type of medication during any phase of the study because it may cause a different response to the proposed treatment.
• Patients with photosensitivity since it will not be possible to apply part of the treatment.

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Radiation:
• Non-Invasive Intravascular Laser Irradiation Of Blood
Participants will receive the treatment for 20 minutes. The laser to be used is infrared-red, 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 will be performed.
• Placebo application of laser
Simulated radiation. One session will be performed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Diagnosis of Temporomandibular Disorders	The Diagnostic Criteria Questionnaire for Temporomandibular Disorders - DC/TMD will be applied before and after treatment.	Baseline and one week after treatment.
Secondary	Changes in Pain Evaluation	Pain will be evaluated using the visual analog scale (VAS). The children will be asked to to mark the intensity of the pain on a corresponding linear scale from 0 to 10, taking 0 without pain and 10 extreme pain.	Baseline and one week after treatment.