Magnetic Ressonance Imaging of Temporomandibular Joint

Temporomandibular Joint Dysfunction Clinical Trial

— MRITMJ  

Official title:

Magnetic Ressonance Imaging Evaluation of Articular Disc Position in TMD Subjects After Mandibular Mobilization. A Double Blind, Randomized, Placebo-controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02294799
• Other study ID #: YEH1984
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: February 2023
• Source: University of Nove de Julho
• Contact: DANIELA AP BIASOTTO-GONZALEZ, PHD
• Phone: +55 11 36659325
• Email: dani_atm[@]ig.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, placebo-controlled, double-blind study designed to verify the effects of nonspecific mandibular mobilization techniques x placebo

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• Intervention Group
Grade 1, Nonspecific Mandibular Mobilization
• Placebo group
Nonspecific Mandibular Movement.

Locations

Country	Name	City	State
Brazil	University of Nove de Julho	Sao Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Daniela Ap. Biasotto-Gonzalez

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging)	Measured by the Magnetic Ressonance Imaging	Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Secondary	Clinical Symptoms (Measured by END)	Measured by numerical scale of pain assessment (END)	Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Secondary	Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)	Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012	Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.
Secondary	Quality of life (Whoqol-bref)	Whoqol-bref	Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up