Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction

NCT ID: NCT02839967

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-25
• Study Completion Date: 2018-01-20

Brief Summary

According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.

Conditions

Temporomandibular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Photobiomodulation group

For the purposes of photobiomodulation is used a portable cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), and 1 905 nm diode LASER, 4 875 nm LED diodes and 4 670 nm diodes LED, 4 cm2 beam, emitting an energy of 39.27 J.

Group Type: EXPERIMENTAL

Photobiomodulation

Intervention Type: OTHER

Intraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed.

Photobiomodulation placebo group

To provide the "blinding" of the participants of the study we will use two identical photobiomodulation equipment supplied by the manufacturer, being an active and another a placebo, but both have identical light and sound device (do not send energy and heat, non-coherent light without biological effect). The devices are named in X and Y for a researcher who does not participate in treatment and assessments.

Group Type: PLACEBO_COMPARATOR

Photobiomodulation placebo

Intervention Type: OTHER

The volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment.

Interventions

Photobiomodulation

Intraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed.

Intervention Type: OTHER

Photobiomodulation placebo

The volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women with disfunction temporomandibular.
• Limitation of mandibular opening below 40 mm.
• score of masticatory muscle pain greater than 3 cm in accordance with EVA.

Exclusion Criteria

• women who have dental failures, total or partial prosthesis.
• systemic diseases .
• history of trauma to the face and or ATMor the ATM dislocation history.
• orthodontic treatment and/or medicated that affects the musculoskeletal system.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Daniela Ap. Biasotto-Gonzalez

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela ap Biasotto-Gonzalez, Phd

Role: PRINCIPAL_INVESTIGATOR

University of Nove de Julho

Locations

University of Nove de Julho

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Herpich CM, Leal-Junior ECP, Politti F, de Paula Gomes CAF, Dos Santos Gloria IP, de Souza Amaral MFR, Herpich G, de Azevedo LMA, de Oliveira Gonzalez T, Biasotto-Gonzalez DA. Intraoral photobiomodulation diminishes pain and improves functioning in women with temporomandibular disorder: a randomized, sham-controlled, double-blind clinical trial : Intraoral photobiomodulation diminishes pain in women with temporomandibular disorder. Lasers Med Sci. 2020 Mar;35(2):439-445. doi: 10.1007/s10103-019-02841-1. Epub 2019 Jul 19.

Reference Type: DERIVED

PMID: 31325122 (View on PubMed)

Other Identifiers

PHOTOBIOMODULATION DTM INT.

Identifier Type: -

Identifier Source: org_study_id