Temporomandibular DisordersNCT02839967
Influence of Intraoral Photobiomodulation in Individuals With Temporomandibular Joint Dysfunction
A study testing Photobiomodulation in people with Temporomandibular Disorders, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Photobiomodulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Sep 2016to 20 Jan 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with disfunction temporomandibular.
- Limitation of mandibular opening below 40 mm.
- score of masticatory muscle pain greater than 3 cm in accordance with EVA.
Who cannot join
- women who have dental failures, total or partial prosthesis.
- systemic diseases .
- history of trauma to the face and or ATMor the ATM dislocation history.
- orthodontic treatment and/or medicated that affects the musculoskeletal system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Intraoral Photobiomodulation on Pain, Joint Mobility, Functionality and Quality of Life in Individuals With Temporomandibular Joint Dysfunction
According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.
- Conditions
- Temporomandibular Disorders
- Being tested
- Photobiomodulation, Photobiomodulation placebo
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationOther
Intraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed.
Photobiomodulation placeboOther
The volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation group | Experimental | For the purposes of photobiomodulation is used a portable cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), and 1 905 nm diode LASER, 4 875 nm LED diodes and 4 670 nm diodes LED, 4 cm2 beam, emitting an energy of 39.27 J. Receives: Other: Photobiomodulation |
| Photobiomodulation placebo group | Placebo comparator | To provide the "blinding" of the participants of the study we will use two identical photobiomodulation equipment supplied by the manufacturer, being an active and another a placebo, but both have identical light and sound device (do not send energy and heat, non-coherent light without biological effect). The devices are named in X and Y for a researcher who does not participate in treatment and assessments. Receives: Other: Photobiomodulation placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain as measured by Visual analogue scale
Visual analogue scale is a tool which allows easy measurement of the intensity of the pain, and consists of a straight line of 10 cm in length, the ends have a verbal description (without pain and worst pain ever felt, respectively), in which the volunteers will be directed to make a perpendicular dash between the two extremes that represents the level of pain she presented at that time.
Measured: five minutes
Measured by joint mobility
Will be used a digital meter to assess the breadth of mandibular movement (in mm), i.e. will be measured the opening of the mouth, sides (right and left) and protrusion.
Measured: ten minutes
Secondary outcomes (2)
Functional as measured by Patient specific Functional scale
Patient specific Functional scale is a global scale, so it can be used for any region of the body. The patient is asked to identify up to 3 activities that are unable to perform or presents any difficulty and may incorporate issues that were not addressed in a generic scale but it's important for the patient's problem. The measurement is made by Likert-type scales of 11 points for each activity, and the higher the average score (0-10) the better the patient's ability to perform the activities.
Measured: ten minutes
quality of life measured by questionnaire (WHOQOL-BREF)
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start25 Sep 2016
- Primary completion10 May 2017
- Study completion20 Jan 2018
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 Temporomandibular DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
- Investigators
- Daniela ap Biasotto-Gonzalez, Phd, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839967
- Sponsor's protocol ID
- PHOTOBIOMODULATION DTM INT.
- Status last verified
- Jan 2019
- First submitted
- 29 Sep 2015
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Herpich CM, Leal-Junior ECP, Politti F, de Paula Gomes CAF, Dos Santos Gloria IP, de Souza Amaral MFR, Herpich G, de Azevedo LMA, de Oliveira Gonzalez T, Biasotto-Gonzalez DA. Intraoral photobiomodulation diminishes pain and improves functioning in women with temporomandibular disorder: a randomized, sham-controlled, double-blind clinical trial : Intraoral photobiomodulation diminishes pain in women with temporomandibular disorder. Lasers Med Sci. 2020 Mar;35(2):439-445. doi: 10.1007/s10103-019-02841-1. Epub 2019 Jul 19.
PubMed 31325122
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Intraoral Photobiomodulation on Pain, Joint Mobility, Functionality and Quality of Life in Individuals With Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT02839967
- Acronym / sponsor ID
- PHOTOBIOMODULATION DTM INT.
- Conditions
- Temporomandibular Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 25 Sep 2016 (actual)
- Primary completion
- 10 May 2017 (actual)
- Study completion
- 20 Jan 2018 (actual)
- First posted
- 21 Jul 2016 (estimated)
- 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.
According to the International Association for the Study of Pain (IASP), the temporomandibular pain and dysfunction syndrome (TMD) is characterized as a subset of orofacial pain, whose signs and symptoms include pain or discomfort in the temporomandibular joints. Pain is considered one of the most common and limiting clinical manifestations. One of the most used resources to treat muscle pain is the low-level laser therapy (LLLT), However, the mechanisms responsible for the effects observed in clinical trials remain poorly elucidated, as well as therapy with light emitting diode therapy (LEDT) which, has some advantages, among them the larger area radiation point and low cost. However, its effects remain elusive in intraoral application in temporal muscle, lateral and medial pterygoid muscle. Assuming that there is need to investigate therapeutic resources that combine not only different wavelengths as well as different light sources (LED and LLLT), this study aims to evaluate the effect of photobiomodulation with a combination of different light sources on pain, joint mobility, equity and quality of jaw movements after treatment in patients with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 2 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, visual analog scale, and kinematics. The protocols will be used in a 6 sessions and will be evaluated in four different moments. The analyses of the data will be performed by adopting a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation group | Experimental | Other: PhotobiomodulationFor the purposes of photobiomodulation is used a portable cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), and 1 905 nm diode LASER, 4 875 nm LED diodes and 4 670 nm diodes LED, 4 cm2 beam, emitting an energy of 39.27 J. |
| Photobiomodulation placebo group | Placebo comparator | Other: Photobiomodulation placeboTo provide the "blinding" of the participants of the study we will use two identical photobiomodulation equipment supplied by the manufacturer, being an active and another a placebo, but both have identical light and sound device (do not send energy and heat, non-coherent light without biological effect). The devices are named in X and Y for a researcher who does not participate in treatment and assessments. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women with disfunction temporomandibular.
- Limitation of mandibular opening below 40 mm.
- score of masticatory muscle pain greater than 3 cm in accordance with EVA.
Key exclusion criteria (4 listed)
- women who have dental failures, total or partial prosthesis.
- systemic diseases .
- history of trauma to the face and or ATMor the ATM dislocation history.
- orthodontic treatment and/or medicated that affects the musculoskeletal system.
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 |
|---|---|---|
| PhotobiomodulationIntraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed. | Other | Photobiomodulation group |
| Photobiomodulation placeboThe volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment. | Other | Photobiomodulation placebo group |
Primary outcome
Intensity of pain as measured by Visual analogue scale
Time frame: five minutes
Visual analogue scale is a tool which allows easy measurement of the intensity of the pain, and consists of a straight line of 10 cm in length, the ends have a verbal description (without pain and worst pain ever felt, respectively), in which the volunteers will be directed to make a perpendicular dash between the two extremes that represents the level of pain she presented at that time.
Measured by joint mobility
Time frame: ten minutes
Will be used a digital meter to assess the breadth of mandibular movement (in mm), i.e. will be measured the opening of the mouth, sides (right and left) and protrusion.
2 secondary outcomes
Functional as measured by Patient specific Functional scale
Time frame: ten minutes
quality of life measured by questionnaire (WHOQOL-BREF)
Time frame: ten minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Derived from this study: PubMed 31325122Herpich CM, Leal-Junior ECP, Politti F, de Paula Gomes CAF, Dos Santos Gloria IP, de Souza Amaral MFR, Herpich G, de Azevedo LMA, de Oliveira Gonzalez T, Biasotto-Gonzalez DA. Intraoral photobiomodulation diminishes pain and improves functioning in women with temporomandibular disorder: a randomized, sham-controlled, double-blind clinical trial : Intraoral photobiomodulation diminishes pain in women with temporomandibular disorder. Lasers Med Sci. 2020 Mar;35(2):439-445. doi: 10.1007/s10103-019-02841-1. Epub 2019 Jul 19.
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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.
Daniela ap Biasotto-Gonzalez, Phd principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation in people with Temporomandibular Disorders, 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain as measured by Visual analogue scale (time frame: five minutes). The study lists 2 primary outcomes in all. 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 NCT02839967, 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 28 Jan 2019.