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Low-level Laser Therapy on Temporomandibular Disorder

Primary Purpose

Temporomandibular Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
low-level laser treatment
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 focused on measuring temporomandibular joint, temporomandibular disorder, electromyography, low-level laser therapy

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Individuals aged 15 to 18 years with diagnosis of TMD and a signed statement of informed consent will be included in the study.

Exclusion Criteria:

  • Individuals with dentofacial anomalies, incomplete permanent dentition to the 2nd molar, currently undergoing orthodontic or orthopedic treatment of the jaws, currently undergoing psychological treatment or physical therapy and making use of a muscle relaxant, anti-inflammatory agent or bite plate will be excluded from the study.

Sites / Locations

  • Universidade Nove de Julho - VergueiroRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

No Intervention

Arm Label

Muscles of mastication

TMJ and muscles

Placebo

Tempormandibular Joint

Withou TMD

Arm Description

This group with TMD will receive low-level laser treatment at masseter and temporal muscles - three points on the masseter (upper, middle and lower) and one point on the anterior temporal

This group with TMD will receive a mixed application of low-level laser treatment- TMJ and muscles of mastication.

This group with TMD will receive a low-level laser placebo treatment at TMJ and muscles of mastication. The same equipment will be used with a pen that emits a red guide light and a warning sound, but without the emission of laser

This group with TMD will receive low-level laser treatment in TMJ region - five points around the TMJ.

This will be a follow up group, with volunteers without TMD.

Outcomes

Primary Outcome Measures

Surface Electromyography of masseter and anterior temporal muscles
The EMG activity will be read under three conditions: at rest, during chewing (isotonic) and during maximum intercuspation (MI) (isometric). Three readings will be made under each condition, with a three-minute rest interval between readings. The readings in the resting position will be performed, lasting 15 seconds each. The readings under the chewing condition will be performed with the volunteer simulating habitual chewing at a pace determined by a metronome adjusted to 60 beats a minute; lasting 15 seconds each. Three 10-seconds MI readings will be then be performed, with no material placed between the arches, following by three five-second readings during maximum clenching effort (MCE) with a folded layer of Parafilm M® between the molars (bilaterally).

Secondary Outcome Measures

visual analog scale
A numeric visual analog scale will be used to record pain upon palpation of the masseter and temporal muscles. It will be applied on the beginning of laser therapy, after 12 sessions of therapy and 30 days following the last session of treatment
mandibular range of motion
The volunteer will be instructed to open the mouth as wide as possible. Maximum voluntary mouth opening (distance between upper and lower central incisors) will be recorded with the aid of a digital caliper. The volunteer will then be instructed to exert pressure on the lower teeth with the index and middle finger to obtain maximum passive mouth opening and move the mandible to the right and left for the determination of excursion (distance between upper and lower midpoints). These procedures will be carried out at the beginning and end of treatment as well as 30 days following the last session

Full Information

First Posted
April 11, 2013
Last Updated
April 30, 2013
Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT01846000
Brief Title
Low-level Laser Therapy on Temporomandibular Disorder
Official Title
Evaluation of Effect of Low-level Laser Therapy on Adolescents With Temporomandibular Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the effect of low-level laser on pain, occlusal contacts, mandibular movements and electromyography activity in the masseter and temporal muscles in adolescents with TMD.
Detailed Description
A randomized, controlled, double-blind, clinical trial will be carried out. Adolescents aged 15 to 18 years will answer the questionnaire of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD)and a specific clinical exam of RDC/TMD will also be carried out for the diagnosis of temporomandibular disorder (TMD), prior to any intervention. They will also be submitted to electromyographic analysis of the masseter muscles and anterior bundle of the temporal muscles bilaterally for the determination of TMD. The type of occlusion of those participants will be determined by the clinical examination based on the Angle classification and the occlusal contact points will be recorded using T-Scan III. Before the intervention, the mandibular range of motion will be assessed by the register of maximum voluntary mouth opening, maximum passive mouth opening and excursion as well as the record pain upon palpation of the masseter and temporal muscles using a visual analog scale. The volunteers diagnosed with TMD will be divided into four groups and two sessions of LLLT or placebo treatment will be carried out over six weeks. One group will receive low-level laser (LLL) treatment on temporomandibular joint(TMJ) region, one will receive LLL treatment at masseter and temporal muscles, one will receive mixed application of LLL (muscles and TMJ) and the other group will receive placebo treatment. After the last session of LLL treatment the electromyographic analysis, the record of occlusal contact points, mandibular range of motion and pain upon palpation will be carried out. 30 days following the last session the occlusal contact points, mandibular range of motion and pain upon palpation will be recorded. Individuals with dentofacial anomalies, incomplete permanent dentition to the 2nd molar, currently undergoing orthodontic or orthopedic treatment of the jaws, currently undergoing psychological treatment or physical therapy and making use of a muscle relaxant, anti-inflammatory agent or bite plate will be excluded from the study. The data will be submitted to descriptive statistical analysis. The chi-square test and Fisher's exact test will be used for the determination of associations among the categorical variables. The Student's t-test and analysis of variance will be used for the comparison of mean electromyographic signals. Pearson's correlation coefficients will be calculated for the analysis of correlations among the continuous variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
temporomandibular joint, temporomandibular disorder, electromyography, low-level laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Muscles of mastication
Arm Type
Experimental
Arm Description
This group with TMD will receive low-level laser treatment at masseter and temporal muscles - three points on the masseter (upper, middle and lower) and one point on the anterior temporal
Arm Title
TMJ and muscles
Arm Type
Experimental
Arm Description
This group with TMD will receive a mixed application of low-level laser treatment- TMJ and muscles of mastication.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group with TMD will receive a low-level laser placebo treatment at TMJ and muscles of mastication. The same equipment will be used with a pen that emits a red guide light and a warning sound, but without the emission of laser
Arm Title
Tempormandibular Joint
Arm Type
Experimental
Arm Description
This group with TMD will receive low-level laser treatment in TMJ region - five points around the TMJ.
Arm Title
Withou TMD
Arm Type
No Intervention
Arm Description
This will be a follow up group, with volunteers without TMD.
Intervention Type
Procedure
Intervention Name(s)
low-level laser treatment
Intervention Description
A gallium-aluminum-arsenide laser will be employed for the LLLT and placebo treatment. The device will be calibrated with a wavelength of 780 nm, energy density of 25 J/cm2, power of 50 mW and power density of 1.25 W/cm2. Exposure time will be 20 seconds per point, resulting in a total energy of 1 J per point. The spot application method will be used in contact with the skin and with a conventional tip, covering an area of 0.04 cm2.
Primary Outcome Measure Information:
Title
Surface Electromyography of masseter and anterior temporal muscles
Description
The EMG activity will be read under three conditions: at rest, during chewing (isotonic) and during maximum intercuspation (MI) (isometric). Three readings will be made under each condition, with a three-minute rest interval between readings. The readings in the resting position will be performed, lasting 15 seconds each. The readings under the chewing condition will be performed with the volunteer simulating habitual chewing at a pace determined by a metronome adjusted to 60 beats a minute; lasting 15 seconds each. Three 10-seconds MI readings will be then be performed, with no material placed between the arches, following by three five-second readings during maximum clenching effort (MCE) with a folded layer of Parafilm M® between the molars (bilaterally).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
visual analog scale
Description
A numeric visual analog scale will be used to record pain upon palpation of the masseter and temporal muscles. It will be applied on the beginning of laser therapy, after 12 sessions of therapy and 30 days following the last session of treatment
Time Frame
10 weeks
Title
mandibular range of motion
Description
The volunteer will be instructed to open the mouth as wide as possible. Maximum voluntary mouth opening (distance between upper and lower central incisors) will be recorded with the aid of a digital caliper. The volunteer will then be instructed to exert pressure on the lower teeth with the index and middle finger to obtain maximum passive mouth opening and move the mandible to the right and left for the determination of excursion (distance between upper and lower midpoints). These procedures will be carried out at the beginning and end of treatment as well as 30 days following the last session
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
occlusal contacts
Description
The T-Scan® III will be used for the recording of occlusal contact points. This system is composed of contact sensors connected to a USB port of a computer. Occlusal forces are recorded using a specific software program. The volunteer will be positioned in a chair at 90 degrees such that the Camper plane is parallel to the ground and will be instructed to performed MI. It will be recorded before the laser therapy and after the last session fo laser therapy.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals aged 15 to 18 years with diagnosis of TMD and a signed statement of informed consent will be included in the study. Exclusion Criteria: Individuals with dentofacial anomalies, incomplete permanent dentition to the 2nd molar, currently undergoing orthodontic or orthopedic treatment of the jaws, currently undergoing psychological treatment or physical therapy and making use of a muscle relaxant, anti-inflammatory agent or bite plate will be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila HL Godoy
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lara J Motta
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniela A Biasotto-Gonzalez
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabiano Politti
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Raquel A Mesquita-Ferrari
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristianne PS Fernandes
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sandra K Bussadori
Organizational Affiliation
University of Nove de Julho
Official's Role
Study Director
Facility Information:
Facility Name
Universidade Nove de Julho - Vergueiro
City
Sao Paulo
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camila HL Godoy
Email
cami_godoy@outlook.com
First Name & Middle Initial & Last Name & Degree
Camila HL Godoy

12. IPD Sharing Statement

Citations:
PubMed Identifier
19565312
Citation
Carvalho CM, de Lacerda JA, dos Santos Neto FP, Cangussu MC, Marques AM, Pinheiro AL. Wavelength effect in temporomandibular joint pain: a clinical experience. Lasers Med Sci. 2010 Mar;25(2):229-32. doi: 10.1007/s10103-009-0695-y. Epub 2009 Jun 30.
Results Reference
background
PubMed Identifier
20491229
Citation
Venezian GC, da Silva MA, Mazzetto RG, Mazzetto MO. Low level laser effects on pain to palpation and electromyographic activity in TMD patients: a double-blind, randomized, placebo-controlled study. Cranio. 2010 Apr;28(2):84-91. doi: 10.1179/crn.2010.012.
Results Reference
background
PubMed Identifier
23876095
Citation
de Godoy CH, Silva PF, de Araujo DS, Motta LJ, Biasotto-Gonzalez DA, Politti F, Mesquita-Ferrari RA, Fernandes KP, Albertini R, Bussadori SK. Evaluation of effect of low-level laser therapy on adolescents with temporomandibular disorder: study protocol for a randomized controlled trial. Trials. 2013 Jul 22;14:229. doi: 10.1186/1745-6215-14-229.
Results Reference
derived

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Low-level Laser Therapy on Temporomandibular Disorder

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