Analgesic Effects of LED Light on Temporomandibular Disorders.

NCT ID: NCT01873937

Last Updated: 2013-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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).

Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Red LED

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

Group Type EXPERIMENTAL

Red LED

Intervention Type RADIATION

Phototherapy with red LED on temporomandibular area

infrared LED

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

Group Type EXPERIMENTAL

INFRARED LED

Intervention Type RADIATION

Phototherapy with infrared LED on temporomandibular area

LASER

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

Group Type ACTIVE_COMPARATOR

LASER

Intervention Type RADIATION

Phototherapy with LASER INFRARED on temporomandibular area

Interventions

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Red LED

Phototherapy with red LED on temporomandibular area

Intervention Type RADIATION

INFRARED LED

Phototherapy with infrared LED on temporomandibular area

Intervention Type RADIATION

LASER

Phototherapy with LASER INFRARED on temporomandibular area

Intervention Type RADIATION

Other Intervention Names

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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

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Fernanda Rossi Paolillo

Vitor Hugo Panhóca

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Panhóca H Panhóca, MS

Role: PRINCIPAL_INVESTIGATOR

IFSC/UFSCAR

Rosane Z Lizarelli, PhD

Role: STUDY_DIRECTOR

University of São Paulo, IFSC

Vanderlei S Bagnato, PhD

Role: STUDY_DIRECTOR

University of São Paulo, IFSC

Locations

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NILO- Integrated Center for Laser in Dentistry

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 15895289 (View on PubMed)

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.

Reference Type RESULT
PMID: 12513918 (View on PubMed)

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.

Reference Type RESULT
PMID: 2746531 (View on PubMed)

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.

Reference Type RESULT
PMID: 21119408 (View on PubMed)

Related Links

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Other Identifiers

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1967

Identifier Type: -

Identifier Source: org_study_id

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