Conservative Therapies in the Treatment of Temporomandibular Disorders

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

Tracking Information

• First Submitted Date: August 3, 2023
• First Posted Date: August 14, 2023
• Last Update Posted Date: September 1, 2023
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: December 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 29, 2023)

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.

Original Primary Outcome Measures (submitted: August 3, 2023)

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 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

Current Secondary Outcome Measures (submitted: August 3, 2023)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Conservative Therapies in the Treatment of Temporomandibular Disorders
• Official Title: Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• Temporomandibular Joint Disorders
• Temporomandibular Joint Pain
• Splints
• Photobiomodulation

Intervention

• Device: Occlusal Splint
  Occlusion Splint
• Radiation: Laser Therapy
  Laser Therapy

Study Arms

• 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.

  Intervention: Device: Occlusal 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.

  Intervention: Radiation: 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.
  Interventions:

  • Device: Occlusal Splint
  • Radiation: Laser Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 3, 2023): 96
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2024
• Estimated Primary Completion Date: December 30, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT05989217
• Other Study ID Numbers: TMJ Disorders
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Daniel Augusto de Faria Almeida, Universidade Federal de Alfenas
• Original Responsible Party: Daniel Augusto de Faria Almeida, Universidade Federal de Alfenas, PhD
• Current Study Sponsor: Universidade Federal de Alfenas
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Universidade Federal de Alfenas
• Verification Date: August 2023