Analgesic Effects of LED Light on Temporomandibular Disorders.

Temporomandibular Disorder Clinical Trial

— LED/TMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873937
• Other study ID #: 1967
• Status: Completed
• Phase: N/A
• First received: May 29, 2013
• Last updated: July 11, 2013
• Start date: April 2009
• Est. completion date: December 2009

Study information

• Verified date: July 2013
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Radiation:
• Red LED
Phototherapy with red LED on temporomandibular area
• INFRARED LED
Phototherapy with infrared LED on temporomandibular area
• LASER
Phototherapy with LASER INFRARED on temporomandibular area

Locations

Country	Name	City	State
Brazil	NILO- Integrated Center for Laser in Dentistry	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Hansson TL. Infrared laser in the treatment of craniomandibular disorders, arthrogenous pain. J Prosthet Dent. 1989 May;61(5):614-7. — View Citation

Öz S, Gökçen-Röhlig 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. — View 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. Epub 2005 May 14. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationships between pain and range of motion	Pain score and mandibular range of motion	2 months	Yes
Secondary	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.	2 months	Yes

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