Clinical trial NCT05989217: Conservative Therapies in the Treatment of Temporomandibular Disorders
Official title: Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Disorders
Temporomandibular Joint Pain
Splints
Photobiomodulation
Keywords: Temporomandibular Joint Disorders
Splints
Laser therapy
Lead sponsor: Universidade Federal de Alfenas
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain in the Temporomandibular Joint and/or masticatory muscles
timeFrame: Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.
Secondary outcomes:
measure: Mouth opening
timeFrame: Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.
measure: Oral Health Impact Profile
timeFrame: Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.
Other outcomes:
Locations:
city: Alfenas
country: Brazil
facility: Universidade Federal de Alfenas
state: Minas Gerais
Study officials:
affiliation: Universidade Federal de Alfenas
name: Daniel Almeida, PhD
role: PRINCIPAL_INVESTIGATOR
References: