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Completed

NCT Number: NCT05989217

Conservative Therapies in the Treatment of Temporomandibular Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Alfenas

Alfenas, Minas Gerais, 37130001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Occlusal splint

Device

Occlusion Splint

laser therapy

Radiation

Laser Therapy

Acupuncture Laser Therapy

Radiation

Acupuncture Laser Therapy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Alfenas

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Aug 14, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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