Magnetic Ressonance Imaging of Temporomandibular Joint (MRITMJ)
Primary Purpose
Temporomandibular Joint Dysfunction
Status
Not yet recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Intervention Group
Placebo group
Sponsored by
About this trial
This is an interventional treatment trial for Temporomandibular Joint Dysfunction focused on measuring Temporomandibular Joint Disorders, Magnetic Ressonance Imaging, Complementary Therapy, Physical Therapy Modalities.
Eligibility Criteria
Inclusion Criteria:
- TMD diagnosed subjects by RDC / TMD confirmed by the MRI findings,
- with anterior disk displacement with or without reduction,
- with full dentition (excluding third molars).
Exclusion Criteria:
- Subjects diagnosed TMD exclusively muscular;
- with posterior and / or medial displacement of the disc;
- showing systemic diseases that affect the joints and / or masticatory muscles;
- neuromuscular diseases;
- hypo / condylar hyperplasia;
- making use of any type of dental prosthesis;
- are in orthodontic and / or physical therapy;
- showing neurological or behavioral disorders that preclude the achievement of MRI and/or
- a history of previous TMJ surgery.
Sites / Locations
- University of Nove de Julho
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Placebo Comparator
Arm Label
Intervention Group
Placebo Group
Arm Description
TMD diagnosed sujects that will receive the mobilization treatment
TMD diagnosed sujects that will receive the placebo treatment
Outcomes
Primary Outcome Measures
Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)
Measured by the Magnetic Ressonance Imaging
Secondary Outcome Measures
Clinical Symptoms (Measured by END)
Measured by numerical scale of pain assessment (END)
Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)
Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012
Quality of life (Whoqol-bref)
Whoqol-bref
Full Information
NCT ID
NCT02294799
First Posted
April 9, 2013
Last Updated
February 27, 2023
Sponsor
Daniela Ap. Biasotto-Gonzalez
1. Study Identification
Unique Protocol Identification Number
NCT02294799
Brief Title
Magnetic Ressonance Imaging of Temporomandibular Joint
Acronym
MRITMJ
Official Title
Magnetic Ressonance Imaging Evaluation of Articular Disc Position in TMD Subjects After Mandibular Mobilization. A Double Blind, Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniela Ap. Biasotto-Gonzalez
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
Background: Among the instrumental devices that have been proposed over the years to integrate the clinical evaluation of temporomandibular joint disorders (TMD), imaging techniques are the most studied, showing that magnetic resonance imaging (MRI) is the technique most need to describe the anatomy of the TMJ and to evaluate the correlation of imaging findings with the clinical diagnosis . Despite the amount available studies on the use of MRI for evaluation of TMJ disorders and treatments, there is a lack of studies that evaluate the imaging findings after physical therapy. Purpose: To evaluate the influence of nonspecific mandibular mobilization about the positioning of the articular disc by MRI in individuals with TMD diagnosis of anterior disc displacement with and without reduction according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Analyze the behavior of pain through the numerical scale of pain assessment (END) at baseline and after each treatment session, the quality of life of individuals with TMD at baseline, immediately, three and six months after the treatment sessions by the World Health Organization Quality of Life Assessment (WHOQOL - BREF), and The Patient's Specific Functional Scale (PSFS) at baseline and after treatment. The treatment will be performed three times a week during four weeks. Metodology: This is a randomized, placebo controlled, blind study designed to assess the effects of techniques nonspecific mandibular mobilization x placebo. Individuals will be randomized and divided into two groups: Group A (intervention) and Group B (placebo). Statistic analysis: The positioning of the articular disc, extracted through the use of MRI, will be considered the primary outcome and, as a secondary outcome will be assessed the quality of life, pain and function after treatment. The adherence of the data to a Gaussian curve will be verified by the Shapiro-Wilk and the data are expressed as mean values and standard deviation. Two-way repeated measures analysis of variance with Bonferroni post hoc test will be used for inter-and intra-group comparisons. The significance level is adjusted p ≤ 0.05.
Detailed Description
This is a randomized, placebo-controlled, double-blind study designed to verify the effects of nonspecific mandibular mobilization techniques x placebo
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Dysfunction
Keywords
Temporomandibular Joint Disorders, Magnetic Ressonance Imaging, Complementary Therapy, Physical Therapy Modalities.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Other
Arm Description
TMD diagnosed sujects that will receive the mobilization treatment
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
TMD diagnosed sujects that will receive the placebo treatment
Intervention Type
Other
Intervention Name(s)
Intervention Group
Other Intervention Name(s)
Mandibular Mobilization
Intervention Description
Grade 1, Nonspecific Mandibular Mobilization
Intervention Type
Other
Intervention Name(s)
Placebo group
Other Intervention Name(s)
Placebo Mandibular Mobilization
Intervention Description
Nonspecific Mandibular Movement.
Primary Outcome Measure Information:
Title
Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)
Description
Measured by the Magnetic Ressonance Imaging
Time Frame
Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Secondary Outcome Measure Information:
Title
Clinical Symptoms (Measured by END)
Description
Measured by numerical scale of pain assessment (END)
Time Frame
Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Title
Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)
Description
Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012
Time Frame
Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Title
Quality of life (Whoqol-bref)
Description
Whoqol-bref
Time Frame
Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
TMD diagnosed subjects by RDC / TMD confirmed by the MRI findings,
with anterior disk displacement with or without reduction,
with full dentition (excluding third molars).
Exclusion Criteria:
Subjects diagnosed TMD exclusively muscular;
with posterior and / or medial displacement of the disc;
showing systemic diseases that affect the joints and / or masticatory muscles;
neuromuscular diseases;
hypo / condylar hyperplasia;
making use of any type of dental prosthesis;
are in orthodontic and / or physical therapy;
showing neurological or behavioral disorders that preclude the achievement of MRI and/or
a history of previous TMJ surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DANIELA AP BIASOTTO-GONZALEZ, PHD
Phone
+55 11 36659325
Email
dani_atm@ig.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ap Biasotto-Gonzalez, PHD
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01415000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19464658
Citation
Ahmad M, Hollender L, Anderson Q, Kartha K, Ohrbach R, Truelove EL, John MT, Schiffman EL. Research diagnostic criteria for temporomandibular disorders (RDC/TMD): development of image analysis criteria and examiner reliability for image analysis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jun;107(6):844-60. doi: 10.1016/j.tripleo.2009.02.023.
Results Reference
background
PubMed Identifier
17242791
Citation
de Lucena LB, Kosminsky M, da Costa LJ, de Goes PS. Validation of the Portuguese version of the RDC/TMD Axis II questionnaire. Braz Oral Res. 2006 Oct-Dec;20(4):312-7. doi: 10.1590/s1806-83242006000400006.
Results Reference
background
PubMed Identifier
8186034
Citation
Gray RJ, Quayle AA, Hall CA, Schofield MA. Physiotherapy in the treatment of temporomandibular joint disorders: a comparative study of four treatment methods. Br Dent J. 1994 Apr 9;176(7):257-61. doi: 10.1038/sj.bdj.4808429.
Results Reference
background
PubMed Identifier
17086858
Citation
Furto ES, Cleland JA, Whitman JM, Olson KA. Manual physical therapy interventions and exercise for patients with temporomandibular disorders. Cranio. 2006 Oct;24(4):283-91. doi: 10.1179/crn.2006.044.
Results Reference
background
PubMed Identifier
16549437
Citation
Ohnuki T, Fukuda M, Nakata A, Nagai H, Takahashi T, Sasano T, Miyamoto Y. Evaluation of the position, mobility, and morphology of the disc by MRI before and after four different treatments for temporomandibular joint disorders. Dentomaxillofac Radiol. 2006 Mar;35(2):103-9. doi: 10.1259/dmfr/25020275.
Results Reference
background
PubMed Identifier
22031594
Citation
Horn KK, Jennings S, Richardson G, Vliet DV, Hefford C, Abbott JH. The patient-specific functional scale: psychometrics, clinimetrics, and application as a clinical outcome measure. J Orthop Sports Phys Ther. 2012 Jan;42(1):30-42. doi: 10.2519/jospt.2012.3727. Epub 2011 Oct 25.
Results Reference
background
PubMed Identifier
16341612
Citation
Aigner M, Forster-Streffleur S, Prause W, Freidl M, Weiss M, Bach M. What does the WHOQOL-Bref measure? Measurement overlap between quality of life and depressive symptomatology in chronic somatoform pain disorder. Soc Psychiatry Psychiatr Epidemiol. 2006 Jan;41(1):81-6. doi: 10.1007/s00127-005-0997-8. Epub 2006 Jan 1.
Results Reference
background
PubMed Identifier
24083628
Citation
El Hage Y, Politti F, de Sousa DF, Herpich CM, Gloria IP, Gomes CA, Amaral AP, de Melo NC, da Silva TC, Arruda EE, Amorim CF, Gadotti IC, Gonzalez TO, Berzin F, Bussadori SK, Garcia MB, Barbosa BR, Biasotto-Gonzalez DA. Effect of mandibular mobilization on electromyographic signals in muscles of mastication and static balance in individuals with temporomandibular disorder: study protocol for a randomized controlled trial. Trials. 2013 Oct 1;14:316. doi: 10.1186/1745-6215-14-316.
Results Reference
background
PubMed Identifier
21856077
Citation
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
Results Reference
background
PubMed Identifier
12839406
Citation
Emshoff R, Brandlmaier I, Gerhard S, Strobl H, Bertram S, Rudisch A. Magnetic resonance imaging predictors of temporomandibular joint pain. J Am Dent Assoc. 2003 Jun;134(6):705-14. doi: 10.14219/jada.archive.2003.0256.
Results Reference
background
PubMed Identifier
23538215
Citation
Emara AS, Faramawey MI, Hassaan MA, Hakam MM. Botulinum toxin injection for management of temporomandibular joint clicking. Int J Oral Maxillofac Surg. 2013 Jun;42(6):759-64. doi: 10.1016/j.ijom.2013.02.009. Epub 2013 Mar 26.
Results Reference
background
Learn more about this trial
Magnetic Ressonance Imaging of Temporomandibular Joint
We'll reach out to this number within 24 hrs