Photobiomodulation, Splints, Temporomandibular Joint Disorders, Temporomandibular Joint Pain
Conditions
Keywords
Temporomandibular Joint Disorders, Splints, Laser therapy
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.
Interventions
DEVICEOcclusal Splint
Occlusion Splint
RADIATIONLaser Therapy
Laser Therapy
RADIATIONAcupuncture Laser Therapy
Acupuncture Laser Therapy
Sponsors
Universidade Federal de Alfenas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain in the Temporomandibular Joint and/or masticatory muscles | 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
| Measure | Time frame | Description |
|---|---|---|
| Mouth opening | 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 | 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. |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORDaniel Almeida, PhD
Universidade Federal de Alfenas
Outcome results
None listed