Conservative Therapies in the Treatment of Temporomandibular Disorders

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.

Study Overview

• Status: Completed
• Conditions: Splints; Temporomandibular Joint Disorders; Temporomandibular Joint Pain; Photobiomodulation
• Intervention / Treatment: Device: Occlusal Splint; Radiation: Laser Therapy; Radiation: Acupuncture Laser Therapy

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Alfenas, Minas Gerais, Brazil, 37130001
      • Universidade Federal de Alfenas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Occlusal Splint; Occlusion Splint
Experimental: 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.	Radiation: Laser Therapy; Laser Therapy
Experimental: Occlusal Splint + Laser Therapy; The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.	Device: Occlusal Splint; Occlusion Splint; Radiation: Laser Therapy; Laser Therapy
Experimental: 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.	Radiation: Acupuncture Laser Therapy; Acupuncture Laser Therapy
Experimental: 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.	Device: Occlusal Splint; Occlusion Splint; Radiation: Acupuncture Laser Therapy; Acupuncture Laser Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.

Collaborators and Investigators

• Sponsor: Universidade Federal de Alfenas
• Investigators: Principal Investigator: Daniel Almeida, PhD, Universidade Federal de Alfenas

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: August 3, 2023
• First Submitted That Met QC Criteria: August 3, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Temporomandibular Joint Disorders; Splints; Laser therapy
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders; Therapeutics; Surgical Procedures, Operative; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Ablation Techniques; Orthotic Devices; Laser Therapy; Occlusal Splints
• Other Study ID Numbers: TMJ Disorders

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No