NCT01873937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

3 months

First QC Date

May 29, 2013

Last Update Submit

July 11, 2013

Conditions

Temporomandibular Disorder

Keywords

LasertherapyLedtherapyTMJspain relieforal aperture

Outcome Measures

Primary Outcomes (1)

  • Relationships between pain and range of motion

    Pain score and mandibular range of motion

    2 months

Secondary Outcomes (1)

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

    2 months

Study Arms (3)

Red LED

EXPERIMENTAL

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

Radiation: Red LED

infrared LED

EXPERIMENTAL

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

Radiation: INFRARED LED

LASER

ACTIVE COMPARATOR

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

Radiation: LASER

Interventions

Red LEDRADIATION

Phototherapy with red LED on temporomandibular area

Also known as: Irradiation parameters: 630 nm, 60 sec and 18 J/cm² per point.
Red LED
INFRARED LEDRADIATION

Phototherapy with infrared LED on temporomandibular area

Also known as: Irradiation parameters: 850 nm, 60 sec and 18J/cm² per point
infrared LED
LASERRADIATION

Phototherapy with LASER INFRARED on temporomandibular area

Also known as: Irradiation parameters: 780 nm, 60 sec and 105 J/cm²
LASER

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NILO- Integrated Center for Laser in Dentistry

Ribeirão Preto, São Paulo, Brazil

Location

Related Publications (4)

  • 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.

    PMID: 15895289RESULT

  • 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.

    PMID: 12513918RESULT

  • 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.

    PMID: 2746531RESULT

  • 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.

    PMID: 21119408RESULT

Related Links

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Lasers

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Panhóca H Panhóca, MS

    IFSC/UFSCAR

    PRINCIPAL INVESTIGATOR

  • Rosane Z Lizarelli, PhD

    University of São Paulo, IFSC

    STUDY DIRECTOR

  • Vanderlei S Bagnato, PhD

    University of São Paulo, IFSC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vitor Hugo Panhóca

Study Record Dates

First Submitted

May 29, 2013

First Posted

June 10, 2013

Study Start

April 1, 2009

Primary Completion

July 1, 2009

Study Completion

December 1, 2009

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

BR(1)