Conservative Therapies in the Treatment of Temporomandibular Disorders

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Occlusal Splint

Laser Therapy

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular Joint Disorders, Splints, Laser therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Universidade Federal de AlfenasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Occlusal Splint

Laser Therapy

Occlusal Splint + Laser Therapy

Arm Description

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.

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.

The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT05989217

First Posted

August 3, 2023

Last Updated

August 29, 2023

Sponsor

Universidade Federal de Alfenas

1. Study Identification

Unique Protocol Identification Number

NCT05989217

Brief Title

Conservative Therapies in the Treatment of Temporomandibular Disorders

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2023 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal de Alfenas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Temporomandibular Joint Disorders, Temporomandibular Joint Pain, Splints, Photobiomodulation

Keywords

Temporomandibular Joint Disorders, Splints, Laser therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Occlusal Splint

Arm Type

Experimental

Arm Description

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.

Arm Title

Laser Therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Occlusal Splint + Laser Therapy

Arm Type

Experimental

Arm Description

The therapies will be associated during the same period as the other groups, ensuring the same application and evaluation protocols.

Intervention Type

Device

Intervention Name(s)

Occlusal Splint

Intervention Description

Occlusion Splint

Intervention Type

Radiation

Intervention Name(s)

Laser Therapy

Intervention Description

Laser Therapy

Primary Outcome Measure Information:

Title

Pain in the Temporomandibular Joint and/or masticatory muscles

Description

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.

Time Frame

Change from baseline pain at 0, 1, 2, 3, 4 and 12 weeks.

Secondary Outcome Measure Information:

Title

Mouth opening

Description

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.

Time Frame

Change from baseline mouth opening at 0, 1, 2, 3, 4, and 12 weeks.

Title

Oral Health Impact Profile

Description

The impact of oral health-related quality of life will be analyzed using the Oral Health Impact Profile - Short form (OHIP-14) questionnaire.

Time Frame

Change from baseline Oral Health Impact Profile at 0, 5 and 12 weeks.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Almeida

Phone

+553537019400

Email

daniel.faria@unifal-mg.edu.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Almeida, PhD

Organizational Affiliation

Universidade Federal de Alfenas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universidade Federal de Alfenas

City

Alfenas

State/Province

Minas Gerais

ZIP/Postal Code

37130001

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniel Almeida, PhD

Phone

+5535999593069

First Name & Middle Initial & Last Name & Degree

Daniel F Almeida, PhD

First Name & Middle Initial & Last Name & Degree

Letícia C Siqueira

12. IPD Sharing Statement

Plan to Share IPD

No

Temporomandibular Joint Disorders, Temporomandibular Joint Pain, Splints

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial