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

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ClinicalTrials.gov Identifier: NCT01873937
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : July 15, 2013
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Fernanda Rossi Paolillo, University of Sao Paulo

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Radiation: Red LED Radiation: INFRARED LED Radiation: LASER Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: COMPARATIVE CLINICAL STUDY OF LIGHT ANALGESIC EFFECT ON TEMPOROMANDIBULAR DISORDER (TMD) USING RED AND INFRARED LED-THERAPY
Study Start Date : April 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: Irradiation parameters: 780 nm, 60 sec and 105 J/cm²




Primary Outcome Measures :
  1. Relationships between pain and range of motion [ Time Frame: 2 months ]
    Pain score and mandibular range of motion


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873937


Locations
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Brazil
NILO- Integrated Center for Laser in Dentistry
Ribeirão Preto, São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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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

Additional Information:
Publications of Results:
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Responsible Party: Fernanda Rossi Paolillo, Vitor Hugo Panhóca, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01873937     History of Changes
Other Study ID Numbers: 1967
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: July 15, 2013
Last Verified: July 2013

Keywords provided by Fernanda Rossi Paolillo, University of Sao Paulo:
Lasertherapy
Ledtherapy
TMJs
pain relief
oral aperture

Additional relevant MeSH terms:
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Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs