NCT01846000

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 3, 2013

Status Verified

April 1, 2013

Enrollment Period

8 months

First QC Date

April 11, 2013

Last Update Submit

April 30, 2013

Conditions

Temporomandibular Disorder

Keywords

temporomandibular jointtemporomandibular disorderelectromyographylow-level laser therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    6 weeks

Secondary Outcomes (2)

  • visual analog scale

    10 weeks

  • mandibular range of motion

    10 weeks

Other Outcomes (1)

  • occlusal contacts

    10 weeks

Study Arms (5)

Muscles of mastication

EXPERIMENTAL

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

Procedure: low-level laser treatment

TMJ and muscles

EXPERIMENTAL

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

Procedure: low-level laser treatment

Placebo

PLACEBO COMPARATOR

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

Procedure: low-level laser treatment

Tempormandibular Joint

EXPERIMENTAL

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

Procedure: low-level laser treatment

Withou TMD

NO INTERVENTION

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

Interventions

low-level laser treatmentPROCEDURE

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.

Muscles of masticationPlaceboTMJ and musclesTempormandibular Joint

Eligibility Criteria

Age15 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho - Vergueiro

São Paulo, São Paulo, 01504-001, Brazil

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19565312BACKGROUND

  • 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.

    PMID: 20491229BACKGROUND

  • 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.

    PMID: 23876095DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Camila HL Godoy

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

  • Lara J Motta

    University of Nove de Julho

    STUDY CHAIR

  • Daniela A Biasotto-Gonzalez

    University of Nove de Julho

    STUDY CHAIR

  • Fabiano Politti

    University of Nove de Julho

    STUDY CHAIR

  • Raquel A Mesquita-Ferrari

    University of Nove de Julho

    STUDY CHAIR

  • Kristianne PS Fernandes

    University of Nove de Julho

    STUDY CHAIR

  • Sandra K Bussadori

    University of Nove de Julho

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

April 11, 2013

First Posted

May 3, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2013

Study Completion

December 1, 2013

Last Updated

May 3, 2013

Record last verified: 2013-04

Locations

BR(1)