Photobiomodulation in Temporomandibular Disorder

NCT03096301 | Unknown

• 1 other identifier: CEPhotobio01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Temporomandibular Disorder

Keywords

temporomandibular disorder; photobiomodulation; pain

Outcome Measures

Primary Outcomes (1)

• Pain

  Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders

  12 months after treatment

Secondary Outcomes (1)

• Cost-effectviness

  12 months after treatment

Study Arms (3)

Low-intensity laser

EXPERIMENTAL

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; Device: Placebo

Occlusal Plate

ACTIVE COMPARATOR

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; Device: Placebo

Placebo

PLACEBO COMPARATOR

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

Interventions

Low-intensity laser DEVICE

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

Low-intensity laser

occlusal plates DEVICE

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

Occlusal Plate

Placebo DEVICE

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

Low-intensity laser; Occlusal Plate; Placebo

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Lara Motta

São Paulo, São Paulo, 18130 430, Brazil

RECRUITING

Related Publications (1)

• Sobral APT, Godoy CLH, Fernandes KPS, Bussadori SK, Ferrari RAM, Horliana ACRT, Monken SF, Motta LJ. Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis. BMJ Open. 2018 May 5;8(5):e018326. doi: 10.1136/bmjopen-2017-018326.

  PMID: 29730613 DERIVED

MeSH Terms

Conditions

Pain; Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Central Study Contacts

Lara Motta, PhD

CONTACT

5511998829511; larajmotta@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 30, 2017
• Study Start: October 10, 2017
• Primary Completion: January 21, 2018
• Study Completion: October 10, 2018
• Last Updated: March 30, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)