Temporomandibular DisorderNCT05297604
Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders
A study testing Vascular photobiomodulation (VPBM) in people with Temporomandibular Disorder, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
This study is blind, randomized controlled and have been carried out on children between 6 and 9 years of age, at the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, and surrounding schools. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder
- What is being tested?
- Vascular photobiomodulation (VPBM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Oct 2022to 10 Nov 2023
- 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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy participants (ASA I) age six to nine years with diagnosis of TMD in the mixed dentition phase and with jaw deviation and/or deflection. Deviation is defined as the jaw following a deviated path to one side during opening. Deflection is defined as the jaw following a deviated path without returning to the midline when the mouth is fully opened.
Who cannot join
- Craniofacial anomalies or genetic syndromes due to the greater probability of the development of TMD associated with the malformation, which could be a confounding variable, malocclusion, use of a dental prosthesis, currently undergoing orthodontic treatment, need for orthognathic surgery or physical therapy due to the potential impact on the results of both the diagnosis and treatment, currently undergoing oncological treatment due to the need to avoid conditions that may exert an influence on the response to the proposed treatment and photosensitivity due to the incompatibility with part of the proposed treatment. Individuals on medications could be included and the medications needed to be recorded in the results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders - Study Protocol For A Randomized, Controlled, Blind, Clinical Trial
This study is blind, randomized controlled and have been carried out on children between 6 and 9 years of age, at the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, and surrounding schools. Patients who present temporomandibular disorders, based on the diagnostic criteria will be the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) were included. The laser used was infrared, power 100 mW ±20%, wavelength 660nm ±10 nm, energy parameter 60J, continuous application. The technique is not invasive, the irradiation point is by continuous and direct transcutaneous application to the radial artery by means of a bracelet that inserts the laser beam. One session has been performed. There was a laser group, a placebo group. Participants in all groups were re-evaluated after the procedure, following the same evaluation procedures used initially, evaluating the effects of ILIB on pain and range of motion.
- Conditions
- Temporomandibular Disorder
- Being tested
- Vascular photobiomodulation (VPBM), Sham group (simulated vascular photobiomodulation)
- 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.
Vascular photobiomodulation (VPBM)Radiation
The participants received a 20-minute single session of VPBM. This noninvasive method involves the use of low-power laser coupled to a bracelet designed to transport the light beam transcutaneously over the radial artery. The laser device (DMC Therapy Ec) delivered irradiation with a power of 100 ± 20 mW, wavelength of 660 ± 10 nm (red light) and energy of 120 J applied continuously, with irradiance of 35 W/cm².
Sham group (simulated vascular photobiomodulation)Radiation
Simulated radiation. The participants received a single session.
| Study group | Role | What they receive |
|---|---|---|
| VPBM group (vascular photobiomodulation) | Active comparator | The participants received a single session of VPBM. Receives: Radiation: Vascular photobiomodulation (VPBM) |
| Sham group (simulated vascular photobiomodulation) | Placebo comparator | The participants received the same treatment as the VPBM group, but the equipment was switched off. To ensure blinding, the sound of the device (beep) was activated at the time of simulated PBM using a telephone. Receives: Radiation: Sham group (simulated vascular photobiomodulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mouth opening range of motion (following clinical protocol of DC/TMD)
Vertical movement of the jaw was measured using calibrated digital calipers.
Measured: Baseline and immediately after the procedure.
Secondary outcomes (1)
Changes in Pain Evaluation
Pain was assessed using the VAS, which is an instrument for the subjective assessment of pain. The subject makes a mark along a horizontal line with 0 (absence of pain) printed at one end and 10 (extreme pain) printed at the other end. The patient's mark on the line is recorded in the clinical history for reproduction among observers.
Measured: Baseline and immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start20 Oct 2022
- Primary completion20 Jun 2023
- Study completion10 Nov 2023
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 DisorderStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297604
- Sponsor's protocol ID
- TMDChildren
- Status last verified
- Oct 2024
- First submitted
- 16 Mar 2022
- Last updated
- 21 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sertaje MRF, Goncalves MLL, Gomes AO, Bruno LH, Fossati AL, Viarengo NO, Santos EM, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial. Medicine (Baltimore). 2022 Oct 21;101(42):e31228. doi: 10.1097/MD.0000000000031228.
PubMed 36281107
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders - Study Protocol For A Randomized, Controlled, Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT05297604
- Acronym / sponsor ID
- TMDChildren
- Conditions
- Temporomandibular Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 28 Mar 2022 (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.
This study is blind, randomized controlled and have been carried out on children between 6 and 9 years of age, at the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, and surrounding schools. Patients who present temporomandibular disorders, based on the diagnostic criteria will be the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) were included. The laser used was infrared, power 100 mW ±20%, wavelength 660nm ±10 nm, energy parameter 60J, continuous application. The technique is not invasive, the irradiation point is by continuous and direct transcutaneous application to the radial artery by means of a bracelet that inserts the laser beam. One session has been performed. There was a laser group, a placebo group. Participants in all groups were re-evaluated after the procedure, following the same evaluation procedures used initially, evaluating the effects of ILIB on pain and range of motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VPBM group (vascular photobiomodulation) | Active comparator | Radiation: Vascular photobiomodulation (VPBM)The participants received a single session of VPBM. |
| Sham group (simulated vascular photobiomodulation) | Placebo comparator | Radiation: Sham group (simulated vascular photobiomodulation)The participants received the same treatment as the VPBM group, but the equipment was switched off. To ensure blinding, the sound of the device (beep) was activated at the time of simulated PBM using a telephone. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy participants (ASA I) age six to nine years with diagnosis of TMD in the mixed dentition phase and with jaw deviation and/or deflection. Deviation is defined as the jaw following a deviated path to one side during opening. Deflection is defined as the jaw following a deviated path without returning to the midline when the mouth is fully opened.
Key exclusion criteria (1 listed)
- Craniofacial anomalies or genetic syndromes due to the greater probability of the development of TMD associated with the malformation, which could be a confounding variable, malocclusion, use of a dental prosthesis, currently undergoing orthodontic treatment, need for orthognathic surgery or physical therapy due to the potential impact on the results of both the diagnosis and treatment, currently undergoing oncological treatment due to the need to avoid conditions that may exert an influence on the response to the proposed treatment and photosensitivity due to the incompatibility with part of the proposed treatment. Individuals on medications could be included and the medications needed to be recorded in the results.
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 |
|---|---|---|
| Vascular photobiomodulation (VPBM)The participants received a 20-minute single session of VPBM. This noninvasive method involves the use of low-power laser coupled to a bracelet designed to transport the light beam transcutaneously over the radial artery. The laser device (DMC Therapy Ec) delivered irradiation with a power of 100 ± 20 mW, wavelength of 660 ± 10 nm (red light) and energy of 120 J applied continuously, with irradiance of 35 W/cm². | Radiation | VPBM group (vascular photobiomodulation) |
| Sham group (simulated vascular photobiomodulation)Simulated radiation. The participants received a single session. | Radiation | Sham group (simulated vascular photobiomodulation) |
Primary outcome
Change in mouth opening range of motion (following clinical protocol of DC/TMD)
Time frame: Baseline and immediately after the procedure.
Vertical movement of the jaw was measured using calibrated digital calipers.
1 secondary outcome
Changes in Pain Evaluation
Time frame: Baseline and immediately after the procedure.
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 21 Oct 2024.
- Derived from this study: PubMed 36281107Sertaje MRF, Goncalves MLL, Gomes AO, Bruno LH, Fossati AL, Viarengo NO, Santos EM, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial. Medicine (Baltimore). 2022 Oct 21;101(42):e31228. doi: 10.1097/MD.0000000000031228.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascular photobiomodulation (VPBM) in people with 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 1 inclusion and 1 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 21 Oct 2024. 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?
Change in mouth opening range of motion (following clinical protocol of DC/TMD) (time frame: Baseline and immediately after the procedure.). 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 NCT05297604, 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 21 Oct 2024.