History of Changes for Study: NCT05989217

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

Latest version (submitted August 29, 2023) on ClinicalTrials.gov

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			August 3, 2023	None (earliest Version on record)
2			August 29, 2023	Eligibility, Outcome Measures, Sponsor/Collaborators, Study Status and Study Identification

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Study NCT05989217
Submitted Date: August 3, 2023 (v1)

Study Identification


Unique Protocol ID:	TMJ Disorders
Brief Title:	Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial
Official Title:	Conservative Therapies in the Treatment of Temporomandibular Disorders: a Randomized Controlled Clinical Trial.
Secondary IDs:

Study Status


Record Verification:	August 2023
Overall Status:	Recruiting
Study Start:	March 1, 2023
Primary Completion:	December 30, 2023 [Anticipated]
Study Completion:	September 30, 2024 [Anticipated]

First Submitted:	August 3, 2023
First Submitted that Met QC Criteria:	August 3, 2023
First Posted:	August 14, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	August 3, 2023
Last Update Posted:	August 14, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Universidade Federal de Alfenas
Responsible Party:	Principal Investigator Investigator: Daniel Augusto de Faria Almeida Official Title: PhD Affiliation: Universidade Federal de Alfenas
Collaborators:

Study Description

Brief 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.

Detailed Description:

Conditions


Conditions:	Temporomandibular Joint Disorders Temporomandibular Joint Pain Splints Photobiomodulation
Keywords:	Temporomandibular Joint Disorders Splints Laser therapy

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Single (Outcomes Assessor)
Allocation:	Randomized
Enrollment:	96 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Occlusal Splint Participants allocated will receive therapy with a stabilizing plate made by the simplified technique. This plate is made of an acetate plate, plasticized in a plaster model, and individualized by acrylic resin. This technique allows the professional to make and install the plate in a short time, without the laboratory step, and is also more economical. After the plate installation and adjustments, the participant will be instructed to use the device every night during sleep. Weekly adjustments will be performed for 4 weeks, and in these sessions information regarding the research parameters will be collected.	Device: Occlusal Splint Occlusion Splint
Experimental: Laser Therapy All participants will be examined and pain trigger points will be identified, if any. The laser will be applied at predetermined points and at specific trigger points identified during the clinical examination. The application of the laser will be symmetrical, i.e. on both sides of the face, with the same number of points, regardless of whether it is a "trigger point" or not. The equipment to be used and the parameters for the applications have the following characteristics: 808 nm wavelength, 100 mW of useful emitter power, 105 J/cm2 of energy density, spot area 0.028 cm2, Energy/point 3 J, 1 application per week for 4 weeks.	Radiation: Laser Therapy Laser Therapy
Experimental: Occlusal Splint + Laser Therapy The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.	Device: Occlusal Splint Occlusion Splint Radiation: Laser Therapy Laser Therapy

Outcome Measures


Primary Outcome Measures:
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 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 Outcome Measures:
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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Adults of legal age, both sexes, regardless of race or social class, will be included, 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: Participants will be excluded in cases of: 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. The patient who insists on a specific treatment (e.g. occlusal adjustments, medication). Presence of removable full or partial dentures with distal extension.

Contacts/Locations


Central Contact Person:	Daniel Almeida Telephone: +553537019400 Email: daniel.faria@unifal-mg.edu.br
Study Officials:	Daniel Almeida, PhD Principal Investigator Universidade Federal de Alfenas
Locations:	Brazil, Minas Gerais
	Universidade Federal de Alfenas [Recruiting] Alfenas, Minas Gerais, Brazil, 37130001 Contact:Contact: Daniel Almeida, PhD +5535999593069 Contact:Principal Investigator: Daniel F Almeida, PhD Contact:Sub-Investigator: Letícia C Siqueira

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