NCT02928809

Brief Summary

The objective of this study is to perform an evaluation of the effect of LLLT on the prevention of fatigue in the masseter and anterior temporal muscles in young individuals with and without TMD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 30, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 6, 2016

Status Verified

December 1, 2016

Enrollment Period

Same day

First QC Date

September 30, 2016

Last Update Submit

December 5, 2016

Conditions

Temporomandibular Joint Disorders

Keywords

temporomandibular jointtemporomandibular disordermuscle fatiguelow-level laser therapy

Outcome Measures

Primary Outcomes (1)

  • Change on Bite Force

    A digital dynamometer will be used for the determination of bite force. The measurements will be taken in the region of the 1st molars.

    6 minutes

Secondary Outcomes (1)

  • Change on range of mandibular movements

    6 minutes

Other Outcomes (2)

  • Change on pain upon palpation

    6 minutes

  • Muscle fatigue

    6 minutes

Study Arms (6)

TMD control

NO INTERVENTION

Patients with diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy

TMD LLL

EXPERIMENTAL

Patients with diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy

Device: low-level laser therapy

Without TMD control

NO INTERVENTION

Patients without diagnosis of temporomandibular disorder and that are not submitted to pre-fatigue low-level laser therapy

Without TMD LLL

EXPERIMENTAL

Patients without diagnosis of temporomandibular disorder and that are submitted to pre-fatigue low-level laser therapy

Device: low-level laser therapy

TMD placebo

PLACEBO COMPARATOR

Patients with diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment

Other: Placebo comparator

Without TMD placebo

PLACEBO COMPARATOR

Patients without diagnosis of temporomandibular disorder and that are submitted to placebo low-level laser treatment

Other: Placebo comparator

Interventions

low-level laser therapyDEVICE

Three points will be irradiated over the masseter muscle (upper, middle and lower bundles) and one point will be irradiated over the anterior temporal muscle of each side of the face in the groups submitted to pre-fatigue laser. The following parameters will be employed: wavelength: 780 nm; energy density: 25 J/cm2; output power: 50 mW; power density: 1.25 W/cm2; and exposure time: 20 seconds per points, resulting in a total energy of 1 J per point. The laser will be applied punctually with a conventional tip in contact with the skin considering an area of 0.04 cm2.

TMD LLLWithout TMD LLL
Placebo comparatorOTHER

The same equipment will be used in the placebo group, but with a pen that emits a red guide light and a warning sound, but without the emission of a laser beam.

TMD placeboWithout TMD placebo

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female individuals aged 18 to 23 years with a signed statement of informed consent will be included in the study.

You may not qualify if:

  • Individuals in orthodontic or orthopedic treatment for the jaws, psychological treatment or physical therapy and those who make use of muscle relaxants, anti-inflammatory agents or bite plates will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Camila HL Godoy, MS

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Camila HL Godoy, MS

CONTACT

55 11 3262-3166cami_godoy@outlook.com

Sandra K Bussadori, PHD

CONTACT

sandra.skb@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

September 30, 2016

First Posted

October 10, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 6, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)