Analgesic Effects of LED Light on Temporomandibular Disorders. (LED/TMD)

July 11, 2013 updated by: Fernanda Rossi Paolillo, University of Sao Paulo

COMPARATIVE CLINICAL STUDY OF LIGHT ANALGESIC EFFECT ON TEMPOROMANDIBULAR DISORDER (TMD) USING RED AND INFRARED LED-THERAPY

Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode) light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Aims: Low intensity laser therapy (LILT) has been widely applied in pain relief in several clinical situations. With the advent of new LED-based (light emitting diode)light sources, the need of further clinical experiments aiming to compare the effectiveness between them is paramount. Method: This study proposes an evaluation of analgesic effect in TMD (temporomandibular disorders) using two different LEDs systems, one emitting at the spectral band of red (630 +/-5 nm) and the other at infrared band (850 +/-5 nm), and compare the results with a laser treated control group (780nm diode laser using 105.7 J/cm2). Mandibular range of motion and report of pain were evaluated via appropriate equipment developed to do this end. Power output was 150mW, tip area was 0.5 cm² for both sources. Fluency or dose chosen was 18 J/cm² for each point of application, around the TMJ, on both sides. Five points were irradiated on TMJ, temporal and masseter muscles. Eight irradiation sessions were done and follow up was performed 7 and 30 days, after last session. Thirty patients were enrolled and they were selected randomly for each treatment, resulting in 10 patients per group (infrared LED, red LED and Control Group using infrared Laser).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil
        • NILO- Integrated Center for Laser in Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Thirty patients (from 18 to 50 years old) presenting signs and symptoms of TMD were selected to participate in the study. The patients received care at a private dental office in Ribeirao Preto, São Paulo, Brazil (NILO- Integrated Center for Laser in Dentistry). The patients´ age ranged from 18 to 40 years old, being 08 male and 22 female. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the TMJ area, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture.

Exclusion Criteria:

The exclusion criteria were patients whom where currently under orthodontic and/or orthopedic treatment, degenerative joint disease, patients who were under systemic medication with anti-inflammatory drugs, analgesic treatment, muscle relaxant and corticosteroids.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Red LED
Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.
Radiation: Red LED
Phototherapy with red LED on temporomandibular area
Other Names:
  • Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.
Experimental: infrared LED
Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point
Radiation: INFRARED LED
Phototherapy with infrared LED on temporomandibular area
Other Names:
  • Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point
Active Comparator: LASER
Irradiation parameters: 780 nm, 60 sec and 105 J/cm²
Radiation: LASER
Phototherapy with LASER INFRARED on temporomandibular area
Other Names:
  • Irradiation parameters: 780 nm, 60 sec and 105 J/cm²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationships between pain and range of motion
Time Frame: 2 months
Pain score and mandibular range of motion
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Research Diagnostic Criteria(RDC)/Temporomandibular Disorders (DTM)
Time Frame: 2 months
RDC/DTM diagnostic exam for research of arthralgia and chronic myofascial pain. The signs and symptoms evaluated by a trained professional were as follow: pain during palpation in the temporomandibular joint, pain on associated muscles (masseter and temporal), and limited or painful jaw movement with impaired oral aperture.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Panhóca H Panhóca, MS, IFSC/UFSCAR
  • Study Director: Rosane Z Lizarelli, PhD, University of São Paulo, IFSC
  • Study Director: Vanderlei S Bagnato, PhD, University of São Paulo, IFSC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

July 15, 2013

Last Update Submitted That Met QC Criteria

July 11, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1967

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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