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

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ClinicalTrials.gov Identifier: NCT03257748
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Sandra Kalil Bussadori, University of Nove de Julho

August 11, 2017
August 22, 2017
May 2, 2018
May 1, 2017
July 20, 2018   (Final data collection date for primary outcome measure)
Visual Analog Scale [ Time Frame: Through study completion, an average of 1 year. ]
This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
Same as current
Complete list of historical versions of study NCT03257748 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • Visual Analog Scale [ Time Frame: Through study completion, an average of 1 year. ]
    This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
  • Maximum vertical mandibular movement [ Time Frame: Through study completion, an average of 1 year. ]
    Maximum vertical mandibular movement: The volunteer will be instructed to open his/her mouth a wide as possible. Maximum vertical mandibular movement will be measured as the distance between the maxillary and mandibular central incisors determined with the aid of digital calipers. The volunteer will then be instructed to exert pressure on the mandibular teeth with the mouth open and move the mandible to the right and left for the determination of excursion (distance between upper and lower mid points). These procedures will be performed before and immediately after treatment.
  • Muscle tension [ Time Frame: Through study completion, an average of 1 year. ]
    Muscle tension: Palpation will be performed of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscle. The classification proposed by Jensen et al. will be used, with the following scores: 0 = absence of pain; 1 = mild discomfort; 2 = moderate pain; and 3 = severe pain. These procedures will be performed before and immediately after treatment.
  • Electromyography [ Time Frame: Through study completion, an average of 1 year. ]
    The electrical signals of the right and left masseter and anterior temporal muscles will be captured. The EMG signal will be determined using a four-channel acquisition system (EMG System do Brasil Ltda.) with a sampling frequency of 2 KHz. The signal will be digitized using an analog-to-digital converter with 16 bits of resolution. The EMGLab (EMG System do Brasil Ltda) will be employed as the acquisition system. These procedures will be performed before and immediately after treatment.
Same as current
 
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder
  • Radiation: 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.
  • 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.
  • Experimental: 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.
    Intervention: Radiation: LED therapy
  • Experimental: 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.
    Intervention: Radiation: Laser Therapy
Langella LG, Silva PFC, Costa-Santos L, Gonçalves 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Same as current
December 20, 2018
July 20, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 70 Years   (Adult, Older Adult)
Yes
Contact: Sandra K Bussadori, PhD +55 11 26339000 sandra.skb@gmail.com
Contact: Luciana G Langella, Ms +55 11 26339000 lucianalangella@hotmail.com
Brazil
 
 
NCT03257748
DTMLU
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Sandra Kalil Bussadori, University of Nove de Julho
University of Nove de Julho
Not Provided
Principal Investigator: Sandra K Bussadori, PhD University of Nove de Julho
University of Nove de Julho
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP