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

Primary Purpose

Temporomandibular Disorder

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Red LED
INFRARED LED
LASER
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder focused on measuring Lasertherapy, Ledtherapy, TMJs, pain relief, oral aperture

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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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Sites / Locations

  • NILO- Integrated Center for Laser in Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Red LED

infrared LED

LASER

Arm Description

Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.

Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point

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

Outcomes

Primary Outcome Measures

Relationships between pain and range of motion
Pain score and mandibular range of motion

Secondary Outcome Measures

Research Diagnostic Criteria(RDC)/Temporomandibular Disorders (DTM)
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.

Full Information

First Posted
May 29, 2013
Last Updated
July 11, 2013
Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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1. Study Identification

Unique Protocol Identification Number
NCT01873937
Brief Title
Analgesic Effects of LED Light on Temporomandibular Disorders.
Acronym
LED/TMD
Official Title
COMPARATIVE CLINICAL STUDY OF LIGHT ANALGESIC EFFECT ON TEMPOROMANDIBULAR DISORDER (TMD) USING RED AND INFRARED LED-THERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder
Keywords
Lasertherapy, Ledtherapy, TMJs, pain relief, oral aperture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Red LED
Arm Type
Experimental
Arm Description
Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.
Arm Title
infrared LED
Arm Type
Experimental
Arm Description
Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point
Arm Title
LASER
Arm Type
Active Comparator
Arm Description
Irradiation parameters: 780 nm, 60 sec and 105 J/cm²
Intervention Type
Radiation
Intervention Name(s)
Red LED
Other Intervention Name(s)
Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.
Intervention Description
Phototherapy with red LED on temporomandibular area
Intervention Type
Radiation
Intervention Name(s)
INFRARED LED
Other Intervention Name(s)
Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point
Intervention Description
Phototherapy with infrared LED on temporomandibular area
Intervention Type
Radiation
Intervention Name(s)
LASER
Other Intervention Name(s)
Irradiation parameters: 780 nm, 60 sec and 105 J/cm²
Intervention Description
Phototherapy with LASER INFRARED on temporomandibular area
Primary Outcome Measure Information:
Title
Relationships between pain and range of motion
Description
Pain score and mandibular range of motion
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Research Diagnostic Criteria(RDC)/Temporomandibular Disorders (DTM)
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panhóca H Panhóca, MS
Organizational Affiliation
IFSC/UFSCAR
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosane Z Lizarelli, PhD
Organizational Affiliation
University of São Paulo, IFSC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Vanderlei S Bagnato, PhD
Organizational Affiliation
University of São Paulo, IFSC
Official's Role
Study Director
Facility Information:
Facility Name
NILO- Integrated Center for Laser in Dentistry
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15895289
Citation
Vinck E, Coorevits P, Cagnie B, De Muynck M, Vanderstraeten G, Cambier D. Evidence of changes in sural nerve conduction mediated by light emitting diode irradiation. Lasers Med Sci. 2005;20(1):35-40. doi: 10.1007/s10103-005-0333-2. Epub 2005 May 14.
Results Reference
result
PubMed Identifier
12513918
Citation
Whelan HT, Connelly JF, Hodgson BD, Barbeau L, Post AC, Bullard G, Buchmann EV, Kane M, Whelan NT, Warwick A, Margolis D. NASA light-emitting diodes for the prevention of oral mucositis in pediatric bone marrow transplant patients. J Clin Laser Med Surg. 2002 Dec;20(6):319-24. doi: 10.1089/104454702320901107.
Results Reference
result
PubMed Identifier
2746531
Citation
Hansson TL. Infrared laser in the treatment of craniomandibular disorders, arthrogenous pain. J Prosthet Dent. 1989 May;61(5):614-7. doi: 10.1016/0022-3913(89)90287-4.
Results Reference
result
PubMed Identifier
21119408
Citation
Oz S, Gokcen-Rohlig B, Saruhanoglu A, Tuncer EB. Management of myofascial pain: low-level laser therapy versus occlusal splints. J Craniofac Surg. 2010 Nov;21(6):1722-8. doi: 10.1097/SCS.0b013e3181f3c76c.
Results Reference
result
Links:
URL
http://cepof.ifsc.usp.br/
Description
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Analgesic Effects of LED Light on Temporomandibular Disorders.

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