Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder

NCT ID: NCT03257748

Last Updated: 2018-10-11

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

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-12-20

Brief Summary

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Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to analyze the effects of low-level laser therapy and light-emitting diode (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70 years of age allocated to either a laser group or LED group submitted to twelve sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale. Orofacial function will be measured based on maximum vertical mandibular movement and muscle tension (determined through palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also be performed.

Detailed Description

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Conditions

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Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LED group

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

Group Type EXPERIMENTAL

LED therapy

Intervention Type RADIATION

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

Laser group

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

Group Type EXPERIMENTAL

Laser Therapy

Intervention Type RADIATION

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

Interventions

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Laser Therapy

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

Intervention Type RADIATION

LED therapy

The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of TMD based on the RDC/TMD;
* Age between 40 and 70 years.

Exclusion Criteria

* Dentofacial anomalies;
* Currently in orthodontic or orthopedic treatment for the jaw;
* Currently undergoing physical therapy;
* Currently undergoing psychological treatment;
* Use of muscle relaxant or anti-inflammatory agent.
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nove de Julho

OTHER

Sponsor Role lead

Responsible Party

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Sandra Kalil Bussadori

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sandra K Bussadori, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

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UniNove

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Sandra K Bussadori, PhD

Role: CONTACT

+55 11 26339000

Luciana G Langella, Ms

Role: CONTACT

+55 11 26339000

Facility Contacts

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Sandra K Bussadori, Ms

Role: primary

+55 11 26339000

References

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Langella LG, Silva PFC, Costa-Santos L, Goncalves MLL, Motta LJ, Deana AM, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial. Trials. 2018 Jan 26;19(1):71. doi: 10.1186/s13063-018-2444-7.

Reference Type DERIVED
PMID: 29373998 (View on PubMed)

Other Identifiers

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DTMLU

Identifier Type: -

Identifier Source: org_study_id

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