Conservative Therapies in the Treatment of Temporomandibular Disorders

NCT ID: NCT05989217

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-09-30

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Occlusal Splint

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.

Group Type: EXPERIMENTAL

Occlusal Splint

Intervention Type: DEVICE

Occlusion Splint

Laser Therapy

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.

Group Type: EXPERIMENTAL

Laser Therapy

Intervention Type: RADIATION

Laser Therapy

Occlusal Splint + Laser Therapy

The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.

Group Type: EXPERIMENTAL

Occlusal Splint

Intervention Type: DEVICE

Occlusion Splint

Laser Therapy

Intervention Type: RADIATION

Laser Therapy

Acupuncture Laser Therapy

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.

Group Type: EXPERIMENTAL

Acupuncture Laser Therapy

Intervention Type: RADIATION

Acupuncture Laser Therapy

Occlusal Splint + Acupuncture Laser Therapy

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.

Group Type: EXPERIMENTAL

Occlusal Splint

Intervention Type: DEVICE

Occlusion Splint

Acupuncture Laser Therapy

Intervention Type: RADIATION

Acupuncture Laser Therapy

Interventions

Occlusal Splint

Occlusion Splint

Intervention Type: DEVICE

Laser Therapy

Laser Therapy

Intervention Type: RADIATION

Acupuncture Laser Therapy

Acupuncture Laser Therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Alfenas

OTHER

Sponsor Role: lead

Responsible Party

Daniel Augusto de Faria Almeida

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Almeida, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Alfenas

Locations

Universidade Federal de Alfenas

Alfenas, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

TMJ Disorders

Identifier Type: -

Identifier Source: org_study_id