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Conservative Therapies in the Treatment of Temporomandibular Disorders

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ClinicalTrials.gov Identifier: NCT05989217
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Daniel Augusto de Faria Almeida, Universidade Federal de Alfenas

Study Description
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Brief Summary:
The present study was designed to compare the effects of the mixed occlusal device using the simplified technique and the low-intensity laser alone or in combination in patients with temporomandibular disorders. A total of 96 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 three groups: Occlusal Device (N=32), Laser (N=32) =32) and Occlusal Device and Laser (N=32). 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. Photobiomodulation will be applied with low-intensity laser at predetermined points and at specific trigger points identified during the clinical examination (3 J/cm2) once a week for four weeks. 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 through the Oral Health Impact Profile (OHIP-14) instrument in a simplified form. The ANOVA test will be used to compare the results obtained between the study groups, while the Repeated Measurements Anova test complemented by the Tukey test will be used for longitudinal evaluation of the data within each group.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Disorders Temporomandibular Joint Pain Splints Photobiomodulation Device: Occlusal Splint Radiation: Laser Therapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.
Actual Study Start Date : March 1, 2023
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mouth opening [ Time Frame: Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks. ]

    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.


  2. Oral Health Impact Profile [ Time Frame: Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks. ]
    The impact of oral health-related quality of life will be analyzed using the Oral Health Impact Profile - Short form (OHIP-14) questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989217


Contacts
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Contact: Daniel Almeida +553537019400 daniel.faria@unifal-mg.edu.br

Locations
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Brazil
Universidade Federal de Alfenas Recruiting
Alfenas, Minas Gerais, Brazil, 37130001
Contact: Daniel Almeida, PhD    +5535999593069      
Principal Investigator: Daniel F Almeida, PhD         
Sub-Investigator: Letícia C Siqueira         
Sponsors and Collaborators
Universidade Federal de Alfenas
Investigators
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Principal Investigator: Daniel Almeida, PhD Universidade Federal de Alfenas
More Information
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Responsible Party: Daniel Augusto de Faria Almeida, Principal Investigator, Universidade Federal de Alfenas
ClinicalTrials.gov Identifier: NCT05989217    
Other Study ID Numbers: TMJ Disorders
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel Augusto de Faria Almeida, Universidade Federal de Alfenas:
Temporomandibular Joint Disorders
Splints
Laser therapy
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Arthralgia
Joint Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Muscular Diseases
 Stomatognathic Diseases
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents