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

Primary Purpose

Temporomandibular Joint Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
low-level laser therapy
Placebo comparator
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Temporomandibular Joint Disorders focused on measuring temporomandibular joint, temporomandibular disorder, muscle fatigue, low-level laser therapy

Eligibility Criteria

18 Years - 23 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Nove de JulhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Experimental

No Intervention

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

TMD control

TMD LLL

Without TMD control

Without TMD LLL

TMD placebo

Without TMD placebo

Arm Description

Patients with diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy

Patients with diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy

Patients without diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy

Patients without diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy

Patients with diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment

Patients without diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment

Outcomes

Primary Outcome Measures

Change on Bite Force
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

Change on range of mandibular movements
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.

Full Information

First Posted
September 30, 2016
Last Updated
December 5, 2016
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02928809
Brief Title
Effect of Low-level Laser Prior to the Induction of Fatigue
Official Title
Effect of Low-level Laser Administered to the Masseter and Anteriortemporal Muscles Prior to the Induction of Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
temporomandibular joint, temporomandibular disorder, muscle fatigue, low-level laser therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMD control
Arm Type
No Intervention
Arm Description
Patients with diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy
Arm Title
TMD LLL
Arm Type
Experimental
Arm Description
Patients with diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Arm Title
Without TMD control
Arm Type
No Intervention
Arm Description
Patients without diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy
Arm Title
Without TMD LLL
Arm Type
Experimental
Arm Description
Patients without diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy
Arm Title
TMD placebo
Arm Type
Placebo Comparator
Arm Description
Patients with diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment
Arm Title
Without TMD placebo
Arm Type
Placebo Comparator
Arm Description
Patients without diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment
Intervention Type
Device
Intervention Name(s)
low-level laser therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Intervention Description
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 Measure Information:
Title
Change on Bite Force
Description
A digital dynamometer will be used for the determination of bite force. The measurements will be taken in the region of the 1st molars.
Time Frame
6 minutes
Secondary Outcome Measure Information:
Title
Change on range of mandibular movements
Description
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.
Time Frame
6 minutes
Other Pre-specified Outcome Measures:
Title
Change on pain upon palpation
Description
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.
Time Frame
6 minutes
Title
Muscle fatigue
Description
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.
Time Frame
6 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camila HL Godoy, MS
Phone
55 11 3262-3166
Email
cami_godoy@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra K Bussadori, PHD
Email
sandra.skb@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila HL Godoy, MS
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Nove de Julho
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila HL Godoy, MS
Phone
55 11 32623166
Email
cami_godoy@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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