Temporomandibular Joint DisordersNCT05989217

Conservative Therapies in the Treatment of Temporomandibular Disorders

A study testing Occlusal Splint, Laser Therapy and Acupuncture Laser Therapy in people with Temporomandibular Joint Disorders and Temporomandibular Joint Pain, run by Universidade Federal de Alfenas at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Temporomandibular Joint Disorders, Temporomandibular Joint Pain, Splints
What is being tested?: Occlusal Splint, Laser Therapy and Acupuncture Laser Therapy
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 160 participants
Where: 1 siteBrazil
Study dates: 1 Mar 2023to 30 Jan 2025
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults of legal age
Both sexes
Regardless of race or social class
With the main complaint of pain in the temporomandibular joint or orofacial region
With or without limitation of mouth opening, diagnosed through the DC/TMD axis1, with pain in the masticatory mm and muscular TMD
Participants must have complete permanent dentition and normal occlusion.

Who cannot join

Congenital problems affecting the TMJ and/or orofacial and cervical region of the skull;
Neoplastic conditions;
History of recent trauma to the orofacial/cervical region of the skull;
Previous use of any type of TMD treatment plate;
Current use of functional orthopedic appliances or fixed and/or removable orthodontic appliances;
Cleft lip and/or palate syndromes;

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Psychiatric disorders;
Severe cardiac problems;
A severely poor dental condition such as periodontitis and/or indication for endodontic treatment;
Those using topical or systemic photosensitizing drugs;
Pregnant women;
Dermatological diseases in the region where irradiation will be performed;
Patients with impaired cognitive ability;
History of head trauma related to the etiology of orofacial pain;
Migraine or intracranial disorders;
Who used medications in the last 3 months that may interfere with the effect of therapies, such as relaxants, anticonvulsants and who used medications to treat TMD or muscular pain;
Who had other causes of orofacial pain, such as caries, neuropathies and fibromyalgia;
Who had phobia about needles or bleeding disorders;
Patients who are unable to attend the clinic during the prescribed treatment period;
Patient who insists on a specific treatment (e.g. occlusal adjustments, medication);
Presence of removable full or partial dentures with distal extension.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Universidade Federal de Alfenas
Alfenas, Minas Gerais, 37130001

Other trials in Brazil

About this study

Official title: Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.

The present study was designed to evaluate different conservative therapies in patients with temporomandibular disorders. A total of 160 patients will be selected after the diagnosis of TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD), axis I. Patients will be randomly divided into five groups: OD group (n=32): treated with an occlusal device; LLLT group (n=32): treated with infrared low-level laser; ODL group (n=32): treated with OD + LLLT; LAT group (n=32): treated with laser acupuncture and ODLAT group (n=32): treated with both OD and LAT. Patients undergoing therapy with a stabilizing plate (made using the simplified technique) will be instructed to use the device every night while sleeping for four weeks. In both the LLLT and LAT groups, the protocol involved five applications: one at baseline, followed by four subsequent weekly sessions. The intensity of pain will be classified using the Visual Analog Scale (VAS). Mandible function will be assessed by maximum unassisted mouth opening. The impact of therapies on oral health will also be evaluated using the Oral Health Impact Profile (OHIP-14) instrument in a simplified form.

Conditions: Temporomandibular Joint Disorders, Temporomandibular Joint Pain, Splints, Photobiomodulation
Being tested: Occlusal Splint, Laser Therapy, Acupuncture Laser Therapy
Keywords: Temporomandibular Joint Disorders, Splints, Laser therapy
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.

Occlusal SplintDevice
Occlusion Splint
Laser TherapyRadiation
Laser Therapy
Acupuncture Laser TherapyRadiation
Acupuncture Laser Therapy

Study groups in NCT05989217
Study group	Role	What they receive
Occlusal Splint	Experimental	Participants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical. After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected. Receives: Device: Occlusal Splint
Laser Therapy	Experimental	All participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a "trigger point" or not. The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks. Receives: Radiation: Laser Therapy
Occlusal Splint + Laser Therapy	Experimental	The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols. Receives: Device: Occlusal Splint; Radiation: Laser Therapy
Acupuncture Laser Therapy	Experimental	The laser will be applied to predetermined acupuncture points and specific trigger points identified during the clinical examination. The application will be performed symmetrically and bilaterally, regardless of the presence of trigger points. A standardized protocol will be followed for all participants, irrespective of tissue thickness or gender. The equipment to be used will emit an infrared light beam with a wavelength of 808 nm, output power of 100 mW, energy density of 105 J/cm², and a spot size of 0.028 cm², delivering 3 J per point, which corresponds to a 30-second application per point. The protocol will consist of five applications: one at baseline, followed by four weekly sessions. Receives: Radiation: Acupuncture Laser Therapy
Occlusal Splint + Acupuncture Laser Therapy	Experimental	In the combined therapy group, the therapies will be administered simultaneously with those of the other groups, ensuring standardized protocols for application and evaluation throughout the study period. Receives: Device: Occlusal Splint; Radiation: Acupuncture Laser Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Pain in the Temporomandibular Joint and/or masticatory muscles
The visual analog scale (VAS) will be used to quantify spontaneous pain in the Temporomandibular Joint and/or masticatory muscles at rest or during palpation. The VAS is a line (ruler) 10 cm long, with a left end point indicating a pain-free state and a right end point indicating the greatest imaginable pain.
Measured: Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.

Secondary outcomes (2)

Mouth opening
Pain-free opening is defined as the maximum amount a patient can achieve when opening their mouth without experiencing pain and will be measured as the distance between the incisal edges of the upper and lower central incisors.
Maximum unassisted mouth opening will be measured as the distance between the upper and lower central incisors and defined as the greatest amount of opening a patient can achieve regardless of pain and discomfort.
Measured: Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.
Oral Health Impact Profile
The impact of oral health-related quality of life will be analyzed using the Oral Health Impact Profile - Short form (OHIP-14) questionnaire.
Measured: Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202330 Jan 2025

First posted14 Aug 2023
Study start1 Mar 2023
Primary completion30 Dec 2023
Study completion30 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Temporomandibular Joint 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05989217
Sponsor's protocol ID: TMJ Disorders
Status last verified: May 2026
First submitted: 3 Aug 2023
Last updated: 26 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

All Temporomandibular Joint Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.
ClinicalTrials.gov ID: NCT05989217
Acronym / sponsor ID: TMJ Disorders
Conditions: Temporomandibular Joint Disorders, Temporomandibular Joint Pain, Splints, Photobiomodulation
Keywords: Temporomandibular Joint Disorders, Splints, Laser therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: Universidade Federal de AlfenasUniversity, hospital or other
Study start: 1 Mar 2023 (actual)
Primary completion: 30 Dec 2023 (actual)
Study completion: 30 Jan 2025 (actual)
First posted: 14 Aug 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Occlusal Splint	Experimental	Device: Occlusal SplintParticipants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical. After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected.
Laser Therapy	Experimental	Radiation: Laser TherapyAll participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a "trigger point" or not. The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks.
Occlusal Splint + Laser Therapy	Experimental	Device: Occlusal Splint, Radiation: Laser TherapyThe therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.
Acupuncture Laser Therapy	Experimental	Radiation: Acupuncture Laser TherapyThe laser will be applied to predetermined acupuncture points and specific trigger points identified during the clinical examination. The application will be performed symmetrically and bilaterally, regardless of the presence of trigger points. A standardized protocol will be followed for all participants, irrespective of tissue thickness or gender. The equipment to be used will emit an infrared light beam with a wavelength of 808 nm, output power of 100 mW, energy density of 105 J/cm², and a spot size of 0.028 cm², delivering 3 J per point, which corresponds to a 30-second application per point. The protocol will consist of five applications: one at baseline, followed by four weekly sessions.
Occlusal Splint + Acupuncture Laser Therapy	Experimental	Device: Occlusal Splint, Radiation: Acupuncture Laser TherapyIn the combined therapy group, the therapies will be administered simultaneously with those of the other groups, ensuring standardized protocols for application and evaluation throughout the study period.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Adults of legal age
Both sexes
Regardless of race or social class
With the main complaint of pain in the temporomandibular joint or orofacial region
With or without limitation of mouth opening, diagnosed through the DC/TMD axis1, with pain in the masticatory mm and muscular TMD

Key exclusion criteria (21 listed)

Congenital problems affecting the TMJ and/or orofacial and cervical region of the skull;
Neoplastic conditions;
History of recent trauma to the orofacial/cervical region of the skull;
Previous use of any type of TMD treatment plate;
Current use of functional orthopedic appliances or fixed and/or removable orthodontic appliances;

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
Occlusal SplintOcclusion Splint	Device	Occlusal Splint, Occlusal Splint + Acupuncture Laser Therapy, Occlusal Splint + Laser Therapy
Laser TherapyLaser Therapy	Radiation	Laser Therapy, Occlusal Splint + Laser Therapy
Acupuncture Laser TherapyAcupuncture Laser Therapy	Radiation	Acupuncture Laser Therapy, Occlusal Splint + Acupuncture Laser Therapy

Primary outcome

Pain in the Temporomandibular Joint and/or masticatory muscles
Time frame: Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.
The visual analog scale (VAS) will be used to quantify spontaneous pain in the Temporomandibular Joint and/or masticatory muscles at rest or during palpation. The VAS is a line (ruler) 10 cm long, with a left end point indicating a pain-free state and a right end point indicating the greatest imaginable pain.

2 secondary outcomes

Mouth opening
Time frame: Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.
Oral Health Impact Profile
Time frame: Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.

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 26 May 2026.
Individual participant dataSharing planned: No

Related trials for Temporomandibular Joint Disorders

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

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.

Daniel Almeida, PhD principal investigator

Universidade Federal de Alfenas

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 21 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 26 May 2026. 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. 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?

Pain in the Temporomandibular Joint and/or masticatory muscles (time frame: Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.). 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 NCT05989217.

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 26 May 2026.