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Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder

Primary Purpose

Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Laser Therapy
LED therapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of TMD based on the RDC/TMD;
  • Age between 40 and 70 years.

Exclusion Criteria:

  • Dentofacial anomalies;
  • Currently in orthodontic or orthopedic treatment for the jaw;
  • Currently undergoing physical therapy;
  • Currently undergoing psychological treatment;
  • Use of muscle relaxant or anti-inflammatory agent.

Sites / Locations

  • UniNoveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

LED group

Laser group

Arm Description

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

Outcomes

Primary Outcome Measures

Visual Analog Scale
This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.

Secondary Outcome Measures

Full Information

First Posted
August 11, 2017
Last Updated
October 10, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03257748
Brief Title
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder
Official Title
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
November 20, 2018 (Anticipated)
Study Completion Date
December 20, 2018 (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
Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to analyze the effects of low-level laser therapy and light-emitting diode (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70 years of age allocated to either a laser group or LED group submitted to twelve sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale. Orofacial function will be measured based on maximum vertical mandibular movement and muscle tension (determined through palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LED group
Arm Type
Experimental
Arm Description
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
Arm Title
Laser group
Arm Type
Experimental
Arm Description
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
Intervention Type
Radiation
Intervention Name(s)
Laser Therapy
Intervention Description
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
Intervention Type
Radiation
Intervention Name(s)
LED therapy
Intervention Description
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
Time Frame
Through study completion, an average of 1 year.
Other Pre-specified Outcome Measures:
Title
Visual Analog Scale
Description
This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
Time Frame
Through study completion, an average of 1 year.
Title
Maximum vertical mandibular movement
Description
Maximum vertical mandibular movement: The volunteer will be instructed to open his/her mouth a wide as possible. Maximum vertical mandibular movement will be measured as the distance between the maxillary and mandibular central incisors determined with the aid of digital calipers. The volunteer will then be instructed to exert pressure on the mandibular teeth with the mouth open and move the mandible to the right and left for the determination of excursion (distance between upper and lower mid points). These procedures will be performed before and immediately after treatment.
Time Frame
Through study completion, an average of 1 year.
Title
Muscle tension
Description
Muscle tension: Palpation will be performed of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscle. The classification proposed by Jensen et al. will be used, with the following scores: 0 = absence of pain; 1 = mild discomfort; 2 = moderate pain; and 3 = severe pain. These procedures will be performed before and immediately after treatment.
Time Frame
Through study completion, an average of 1 year.
Title
Electromyography
Description
The electrical signals of the right and left masseter and anterior temporal muscles will be captured. The EMG signal will be determined using a four-channel acquisition system (EMG System do Brasil Ltda.) with a sampling frequency of 2 KHz. The signal will be digitized using an analog-to-digital converter with 16 bits of resolution. The EMGLab (EMG System do Brasil Ltda) will be employed as the acquisition system. These procedures will be performed before and immediately after treatment.
Time Frame
Through study completion, an average of 1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of TMD based on the RDC/TMD; Age between 40 and 70 years. Exclusion Criteria: Dentofacial anomalies; Currently in orthodontic or orthopedic treatment for the jaw; Currently undergoing physical therapy; Currently undergoing psychological treatment; Use of muscle relaxant or anti-inflammatory agent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra K Bussadori, PhD
Phone
+55 11 26339000
Email
sandra.skb@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana G Langella, Ms
Phone
+55 11 26339000
Email
lucianalangella@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra K Bussadori, PhD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
UniNove
City
São Paulo
State/Province
SP
ZIP/Postal Code
01504001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra K Bussadori, Ms
Phone
+55 11 26339000
Email
sandra.skb@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29373998
Citation
Langella LG, Silva PFC, Costa-Santos L, Goncalves MLL, Motta LJ, Deana AM, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial. Trials. 2018 Jan 26;19(1):71. doi: 10.1186/s13063-018-2444-7. Erratum In: Trials. 2018 Dec 24;19(1):702.
Results Reference
derived

Learn more about this trial

Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder

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