Conservative Therapies in the Treatment of Temporomandibular Disorders

NCT05989217 | Active Not Recruiting DMC

• 1 other identifier: TMJ Disorders
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Keywords

Temporomandibular Joint Disorders; Splints; Laser therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.

Secondary Outcomes (2)

• Mouth opening

  Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.

• Oral Health Impact Profile

  Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.

Study Arms (5)

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.

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.

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.

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.

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.

Device: Occlusal Splint; Radiation: Acupuncture Laser Therapy

Interventions

Occlusal Splint DEVICE

Occlusion Splint

Occlusal Splint; Occlusal Splint + Acupuncture Laser Therapy; Occlusal Splint + Laser Therapy

Laser Therapy RADIATION

Laser Therapy

Laser Therapy; Occlusal Splint + Laser Therapy

Acupuncture Laser Therapy RADIATION

Acupuncture Laser Therapy

Acupuncture Laser Therapy; Occlusal Splint + Acupuncture Laser Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Universidade Federal de Alfenas: lead

Study Sites (1)

Universidade Federal de Alfenas

Alfenas, Minas Gerais, 37130001, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Occlusal Splints; Laser Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Daniel Almeida, PhD

  Universidade Federal de Alfenas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: March 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: September 30, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)