Comparing treatments for jaw pain using splints and laser therapy

Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.

This study is testing whether a mouth splint, laser therapy, or a combination of both can help adults with jaw pain feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidade Federal de Alfenas (Academic / other)
• Locations: 1 site (Alfenas, Minas Gerais)
• Trial ID: NCT05989217 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of a mixed occlusal device and low-intensity laser therapy in treating temporomandibular disorders (TMD). A total of 96 adult patients diagnosed with TMD will be randomly assigned to one of three treatment groups: occlusal device, laser therapy, or a combination of both. The occlusal device will be used nightly for four weeks, while laser therapy will be administered weekly at specific trigger points. Pain intensity will be measured using the Visual Analog Scale, and jaw function will be assessed throughout the treatment period.

Who should consider this trial

Good fit: Ideal candidates include adults experiencing pain in the temporomandibular joint or orofacial region, diagnosed with TMD.

Not a fit: Patients with congenital TMJ issues, neoplastic conditions, or severe dental problems may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective non-invasive treatment options for patients suffering from temporomandibular disorders.

How similar studies have performed: Previous studies have shown promising results with similar approaches using occlusal devices and laser therapy for TMD treatment.

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.

Where this trial is running

Alfenas, Minas Gerais

• Universidade Federal de Alfenas — Alfenas, Minas Gerais, Brazil (Recruiting)

Study contacts

• Principal investigator: Daniel Almeida, PhD — Universidade Federal de Alfenas
• Study coordinator: Daniel Almeida

Conditions Temporomandibular Joint Disorders; Temporomandibular Joint Pain; Splints; Photobiomodulation; Laser therapy