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

Primary Purpose

Temporomandibular Disorder

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Non-Invasive Intravascular Laser Irradiation Of Blood
Placebo application of laser
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder

Eligibility Criteria

6 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    No Intervention

    Arm Label

    Non-Invasive Intravascular Laser Irradiation Of Blood Group

    Placebo group

    Control group

    Arm Description

    Participants in this group will receive low-intensity laser that is attached to a bracelet that has been developed so that the light beam is transported transcutaneously over the radial artery.

    Participants will be treated in the same way as the active group. The person in charge of the ILIB application will simulate the irradiation with the equipment kept off, so that the participant does not identify the group to which he belongs, and the device activation sound (beep) will be turned on at the time of application.

    Composed of individuals who will not receive any type of intervention.

    Outcomes

    Primary Outcome Measures

    Changes in the Diagnosis of Temporomandibular Disorders
    The Diagnostic Criteria Questionnaire for Temporomandibular Disorders - DC/TMD will be applied before and after treatment.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    March 16, 2022
    Last Updated
    May 15, 2023
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05297604
    Brief Title
    Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 20, 2023 (Anticipated)
    Primary Completion Date
    June 20, 2024 (Anticipated)
    Study Completion Date
    December 10, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Non-Invasive Intravascular Laser Irradiation Of Blood Group
    Arm Type
    Active Comparator
    Arm Description
    Participants in this group will receive low-intensity laser that is attached to a bracelet that has been developed so that the light beam is transported transcutaneously over the radial artery.
    Arm Title
    Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will be treated in the same way as the active group. The person in charge of the ILIB application will simulate the irradiation with the equipment kept off, so that the participant does not identify the group to which he belongs, and the device activation sound (beep) will be turned on at the time of application.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Composed of individuals who will not receive any type of intervention.
    Intervention Type
    Radiation
    Intervention Name(s)
    Non-Invasive Intravascular Laser Irradiation Of Blood
    Intervention Description
    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.
    Intervention Type
    Radiation
    Intervention Name(s)
    Placebo application of laser
    Intervention Description
    Simulated radiation. One session will be performed.
    Primary Outcome Measure Information:
    Title
    Changes in the Diagnosis of Temporomandibular Disorders
    Description
    The Diagnostic Criteria Questionnaire for Temporomandibular Disorders - DC/TMD will be applied before and after treatment.
    Time Frame
    Baseline and one week after treatment.
    Secondary Outcome Measure Information:
    Title
    Changes in Pain Evaluation
    Description
    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.
    Time Frame
    Baseline and one week after treatment.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    36281107
    Citation
    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.
    Results Reference
    derived

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

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