NCT01659840

Brief Summary

The study hypothesis was that the red (600nm) and infrared (800nm) laser therapy have the same efficacy in relieving pain and improving the quality of life of TMD patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2012

Completed
Last Updated

August 8, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

August 6, 2012

Last Update Submit

August 7, 2012

Conditions

Keywords

laser,quality of life,orofacial pain

Outcome Measures

Primary Outcomes (1)

  • pain points of muscle and articulation

    180 days

Secondary Outcomes (1)

  • Quality of life

    180 days

Study Arms (2)

Red laser

OTHER

On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.

Radiation: Red laser

Infrared laser

OTHER

On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.

Radiation: Infrared laser

Interventions

Red laserRADIATION

On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.

Red laser

On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.

Infrared laser

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • systemic health;
  • Temporomandibular Disorder diagnosed by the Research Diagnostic Criteria for Temporomandibular Disorders questionnaire (RDC);
  • pain score ≥ 5 on palpation according to a visual and numerical scale (VNS)

You may not qualify if:

  • participants who made frequent use of analgesics, NSAIDs and antidepressants;
  • patients with previously undergone TMD treatment, or suffered facial trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Periodontics Clinic, Department of Dentistry

Diamantina, Minas Gerais, 39100000, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersFacial Pain

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Olga D Flecha, Professor

    Federal University of the Valleys of Jequitinhonha and Mucuri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 8, 2012

Study Start

September 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 8, 2012

Record last verified: 2012-08

Locations