Study Results
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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UNKNOWN
NA
45 participants
INTERVENTIONAL
2017-10-10
2018-10-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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
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
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.
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
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
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
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
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
Interventions
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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
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
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.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of TMD in group I
Exclusion Criteria
* orthodontic or orthopedic treatment
* Individuals who were taking muscle relaxants or anti-inflammatory medications
15 Years
25 Years
ALL
No
Sponsors
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University of Nove de Julho
OTHER
Responsible Party
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Lara Jansiski Motta
Professor
Locations
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Lara Motta
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Lara Motta, PhD
Role: primary
References
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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.
Other Identifiers
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CEPhotobio01
Identifier Type: -
Identifier Source: org_study_id