Conservative Therapies in the Treatment of Temporomandibular Disorders (NCT05989217) | Clinical Trial Compass
CompletedNot Applicable
Conservative Therapies in the Treatment of Temporomandibular Disorders
Brazil160 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain in the Temporomandibular Joint and/or masticatory muscles
Timeframe: Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.