PainNCT03096301
Photobiomodulation in Temporomandibular Disorder
A study testing Low-intensity laser and occlusal plates in people with Pain and Temporomandibular Disorder, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Pain, Temporomandibular Disorder
- What is being tested?
- Low-intensity laser and occlusal plates
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Oct 2017to 10 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- people between 15 and 25 years
- diagnosis of TMD in group I
Who cannot join
- Individuals with dental-facial anomalies
- orthodontic or orthopedic treatment
- Individuals who were taking muscle relaxants or anti-inflammatory medications
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Lara Motta
São Paulo, São Paulo, 18130 430
Lara Motta, PhD, 5511998829511, larajmotta@terra.com.br
About this study
Official title: Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.
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.
Read the 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.
- Conditions
- Pain, Temporomandibular Disorder
- Being tested
- Low-intensity laser, occlusal plates, Placebo
- Keywords
- temporomandibular disorder, photobiomodulation, pain
- Medical subject headings
- Pain, Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity laserDevice
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 platesDevice
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
PlaceboDevice
For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders
Measured: 12 months after treatment
Secondary outcomes (1)
Cost-effectviness
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.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start10 Oct 2017
- Primary completion21 Jan 2018
- Study completion10 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lara Jansiski Motta, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096301
- Sponsor's protocol ID
- CEPhotobio01
- Status last verified
- Mar 2018
- First submitted
- 9 Mar 2017
- Last updated
- 30 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29730613
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.
- ClinicalTrials.gov ID
- NCT03096301
- Acronym / sponsor ID
- CEPhotobio01
- Conditions
- Pain, Temporomandibular Disorder
- Keywords
- temporomandibular disorder, photobiomodulation, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 21 Jan 2018 (actual)
- Study completion
- 10 Oct 2018 (estimated)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Low-intensity laser | Experimental | Device: Low-intensity laser, Device: PlaceboTwelve 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 |
| Occlusal Plate | Active comparator | Device: occlusal plates, Device: PlaceboThe 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 | Placebo comparator | Device: PlaceboFor the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- people between 15 and 25 years
- diagnosis of TMD in group I
Key exclusion criteria (3 listed)
- Individuals with dental-facial anomalies
- orthodontic or orthopedic treatment
- Individuals who were taking muscle relaxants or anti-inflammatory medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-intensity laserLaser 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 | Low-intensity laser |
| occlusal platesThe 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 Plate |
| PlaceboFor the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off. | Device | Low-intensity laser, Occlusal Plate, Placebo |
Primary outcome
Pain
Time frame: 12 months after treatment
Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders
1 secondary outcome
Cost-effectviness
Time frame: 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 29730613Sobral 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity laser and occlusal plates in people with Pain and Temporomandibular Disorder, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lara Motta, PhD (5511998829511, larajmotta@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2018.