Conservative Therapies in the Treatment of Temporomandibular Disorders

Temporomandibular Joint Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05989217
• Other study ID #: TMJ Disorders
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: August 2023
• Source: Universidade Federal de Alfenas
• Contact: Daniel Almeida
• Phone: +553537019400
• Email: daniel.faria[@]unifal-mg.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: September 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthralgia
• Joint Diseases
• Photobiomodulation
• Splints
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Temporomandibular Joint Pain

Intervention

Device:
• Occlusal Splint
Occlusion Splint

Radiation:
• Laser Therapy
Laser Therapy

Locations

Country	Name	City	State
Brazil	Universidade Federal de Alfenas	Alfenas	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Alfenas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain in the Temporomandibular Joint and/or masticatory muscles	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.	Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.
Secondary	Mouth opening	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.	Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.
Secondary	Oral Health Impact Profile	The impact of oral health-related quality of life will be analyzed using the Oral Health Impact Profile - Short form (OHIP-14) questionnaire.	Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.