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Effect of Low-level Laser Prior to the Induction of Fatigue

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ClinicalTrials.gov Identifier: NCT02928809
Recruitment Status : Unknown
Verified December 2016 by Camila Haddad Leal de Godoy, University of Nove de Julho.
Recruitment status was:  Recruiting
First Posted : October 10, 2016
Last Update Posted : December 6, 2016
Sponsor:
Information provided by (Responsible Party):
Camila Haddad Leal de Godoy, University of Nove de Julho

Brief Summary:
The objective of this study is to perform an evaluation of the effect of LLLT on the prevention of fatigue in the masseter and anterior temporal muscles in young individuals with and without TMD.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Device: low-level laser therapy Other: Placebo comparator Not Applicable

Detailed Description:
Male and female individuals aged 18 to 23 years will be evaluated. The Research Diagnostic Criteria for Temporomandibular Disorders will be applied for the determination of the presence or absence of temporomandibular disorder. Each group (with and without temporomandibular disorder) will then be randomly allocated into a control group and experimental group submitted to pre-fatigue low-level laser therapy. Before and after the induction of fatigue, all volunteers will be evaluated with regard to the range of mandibular movement, bite force, sensitivity to palpation of the muscles evaluated and muscle fatigue. Low-level laser therapy will be administered to the masseter and anterior temporal muscles prior to the induction of fatigue, which will be induced with the use of chewing gum. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used to establish the associations of the categorical variables. Pearson correlation coefficients will be calculated for the analysis of the correlation of the continuous variables.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Low-level Laser Administered to the Masseter and Anteriortemporal Muscles Prior to the Induction of Fatigue
Study Start Date : December 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: TMD control
Patients with diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy
Experimental: TMD LLL
Patients with diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Device: low-level laser therapy
Three points will be irradiated over the masseter muscle (upper, middle and lower bundles) and one point will be irradiated over the anterior temporal muscle of each side of the face in the groups submitted to pre-fatigue laser. The following parameters will be employed: wavelength: 780 nm; energy density: 25 J/cm2; output power: 50 mW; power density: 1.25 W/cm2; and exposure time: 20 seconds per points, resulting in a total energy of 1 J per point. The laser will be applied punctually with a conventional tip in contact with the skin considering an area of 0.04 cm2.

No Intervention: Without TMD control
Patients without diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy
Experimental: Without TMD LLL
Patients without diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Device: low-level laser therapy
Three points will be irradiated over the masseter muscle (upper, middle and lower bundles) and one point will be irradiated over the anterior temporal muscle of each side of the face in the groups submitted to pre-fatigue laser. The following parameters will be employed: wavelength: 780 nm; energy density: 25 J/cm2; output power: 50 mW; power density: 1.25 W/cm2; and exposure time: 20 seconds per points, resulting in a total energy of 1 J per point. The laser will be applied punctually with a conventional tip in contact with the skin considering an area of 0.04 cm2.

Placebo Comparator: TMD placebo
Patients with diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment
Other: Placebo comparator
The same equipment will be used in the placebo group, but with a pen that emits a red guide light and a warning sound, but without the emission of a laser beam.

Placebo Comparator: Without TMD placebo
Patients without diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment
Other: Placebo comparator
The same equipment will be used in the placebo group, but with a pen that emits a red guide light and a warning sound, but without the emission of a laser beam.




Primary Outcome Measures :
  1. Change on Bite Force [ Time Frame: 6 minutes ]
    A digital dynamometer will be used for the determination of bite force. The measurements will be taken in the region of the 1st molars.


Secondary Outcome Measures :
  1. Change on range of mandibular movements [ Time Frame: 6 minutes ]
    The individuals will be instructed to open their mouths as wide as possible and maximum active vertical mandibular movement (distance between maxillary and mandibular central incisors) will be recorded with the aid of digital calipers. The individuals will then be instructed to repeat the motion with pressure applied to the maxillary and mandibular teeth to obtain maximum passive vertical mandibular movement with the aid of the calipers. These measurements will be made before and after LLLT.


Other Outcome Measures:
  1. Change on pain upon palpation [ Time Frame: 6 minutes ]
    The visual analog scale will be used before and after treatment to record pain upon palpation of the masseter and anterior temporal muscles. This is a numerical scale ranging from 0 (absence of pain) to 10 (worst pain imaginable) points.

  2. Muscle fatigue [ Time Frame: 6 minutes ]
    Muscle fatigue will be measured using the visual analog scale, which is a subjective measure that consists of a 10-centimeter line with 0 (absence of fatigue) printed at one end and 10 (maximum fatigue) printed at the other end.



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Ages Eligible for Study:   18 Years to 23 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female individuals aged 18 to 23 years with a signed statement of informed consent will be included in the study.

Exclusion Criteria:

  • Individuals in orthodontic or orthopedic treatment for the jaws, psychological treatment or physical therapy and those who make use of muscle relaxants, anti-inflammatory agents or bite plates will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928809


Contacts
Contact: Camila HL Godoy, MS 55 11 3262-3166 cami_godoy@outlook.com
Contact: Sandra K Bussadori, PHD sandra.skb@gmail.com

Locations
Brazil
Universidade Nove de Julho Recruiting
Sao Paulo, SP, Brazil, 01504-001
Contact: Camila HL Godoy, MS    55 11 32623166    cami_godoy@outlook.com   
Sponsors and Collaborators
University of Nove de Julho
Investigators
Principal Investigator: Camila HL Godoy, MS University of Nove de Julho

Responsible Party: Camila Haddad Leal de Godoy, Doctoral Student, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT02928809     History of Changes
Other Study ID Numbers: LLLMF
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Camila Haddad Leal de Godoy, University of Nove de Julho:
temporomandibular joint
temporomandibular disorder
muscle fatigue
low-level laser therapy

Additional relevant MeSH terms:
Fatigue
Joint Diseases
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Signs and Symptoms
Musculoskeletal Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes