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Photobiomodulation in Temporomandibular Disorder

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ClinicalTrials.gov Identifier: NCT03096301
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Lara Jansiski Motta, University of Nove de Julho

Brief Summary:
The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with TMD.

Condition or disease Intervention/treatment Phase
Pain Temporomandibular Disorder Device: Low-intensity laser Device: occlusal plates Device: Placebo Not Applicable

Detailed Description:
Temporomandibular disorder (TMD) affects a significant portion of the population. Epidemiological data show that the signs and symptoms of TMD start to become apparent from six years of age, and in adolescence these signs and symptoms are similar to those of adults. The painful conditions of TMD can affect the quality of life of young patients, compromising the daily activities of these individuals. The present project aims (1) to estimate the direct costs of treatment of muscle pain in patients with TMD with low-intensity laser and with occlusal plate and a placebo group; (2) to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD; (3) to analyze the cost-effectiveness of the two proposed treatments for pain; and (4) to describe and compare the results of analyses of treatments for pain in patients with TMD. The study will be conducted at the Odontological Clinic of Universidade Nove de Julho. It is a prospective trial of clinical and economic analysis. It will include 30 patients aged between 15 and 25 years with TMD, randomly assigned to a treatment group: G1 (low-power laser), G2 (occlusal plate) and G3 (placebo). The analysis will be based on the direct costs of each treatment during the 12-month period, estimating the cost of each treatment. The outcome for the analysis of the effectiveness will be the pain, measured periodically by means of the clinical examination of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The cost-effectiveness ratio will be calculated using, as endpoints, pain and the calculation of the ratio between the difference in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: It is a prospective trial of clinical and economic analysis. It will include 45 patients to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : January 21, 2018
Estimated Study Completion Date : October 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-intensity laser
Twelve laser applications will be applied as initial treatment, with 2 sessions per week. A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point. The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2, in accordance with the protocol suggested by Venezian et al. (2010) and Carvalho et al. (2010). The laser will be applied to 3 points of the masseter muscle (upper, middle, and lower bundles) and 1 point in the anterior temporalis on each side of the face
Device: Low-intensity laser
Laser applications will be applied as initial treatment, with 2 sessions per week. A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point. The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2

Device: Placebo
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.

Active Comparator: Occlusal Plate

The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998).

Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide.

Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment

Device: occlusal plates

The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998).

Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide.

Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment


Device: Placebo
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.

Placebo Comparator: Placebo
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
Device: Placebo
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.




Primary Outcome Measures :
  1. Pain [ Time Frame: 12 months after treatment ]
    Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders


Secondary Outcome Measures :
  1. Cost-effectviness [ Time Frame: 12 months after treatment ]
    This phase of the study will consist in the quantification of resources, i.e. determining the frequency of use of resources and materials during the treatment. The units used to quantify the direct costs consumed are physical units such as consultation time, number of sessions, equipment used, and materials consumed. These data will be collected using a specific form.



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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • people between 15 and 25 years
  • diagnosis of TMD in group I

Exclusion Criteria:

  • Individuals with dental-facial anomalies
  • orthodontic or orthopedic treatment
  • Individuals who were taking muscle relaxants or anti-inflammatory medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03096301


Contacts
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Contact: Lara Motta, PhD 5511998829511 larajmotta@terra.com.br

Locations
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Brazil
Lara Motta Recruiting
São Paulo, Sao Paulo, Brazil, 18130 430
Contact: Lara Motta, PhD    5511998829511    larajmotta@terra.com.br   
Sponsors and Collaborators
University of Nove de Julho

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lara Jansiski Motta, Professor, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT03096301     History of Changes
Other Study ID Numbers: CEPhotobio01
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lara Jansiski Motta, University of Nove de Julho:
temporomandibular disorder
photobiomodulation
pain
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents