Magnetic Ressonance Imaging of Temporomandibular Joint

NCT02294799 | Not Yet Recruiting DMC

• 1 other identifier: YEH1984
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Dysfunction

Keywords

Temporomandibular Joint Disorders; Magnetic Ressonance Imaging; Complementary Therapy; Physical Therapy Modalities.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Clinical Symptoms (Measured by END)

  Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.

• Functionality (Mesuread by "The Patient´s Specific Funcional Scale - HORN, 2012)

  Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.

• Quality of life (Whoqol-bref)

  Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up

Study Arms (2)

Intervention Group

OTHER

TMD diagnosed sujects that will receive the mobilization treatment

Other: Intervention Group

Placebo Group

PLACEBO COMPARATOR

TMD diagnosed sujects that will receive the placebo treatment

Other: Placebo group

Interventions

Intervention Group OTHER

Grade 1, Nonspecific Mandibular Mobilization

Also known as: Mandibular Mobilization

Intervention Group

Placebo group OTHER

Nonspecific Mandibular Movement.

Also known as: Placebo Mandibular Mobilization

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniela Ap. Biasotto-Gonzalez: lead

Study Sites (1)

University of Nove de Julho

São Paulo, São Paulo, 01415000, Brazil

Location

Related 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.

  PMID: 19464658 BACKGROUND

• 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.

  PMID: 17242791 BACKGROUND

• 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.

  PMID: 8186034 BACKGROUND

• 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.

  PMID: 17086858 BACKGROUND

• 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.

  PMID: 16549437 BACKGROUND

• 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.

  PMID: 22031594 BACKGROUND

• 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.

  PMID: 16341612 BACKGROUND

• 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.

  PMID: 24083628 BACKGROUND

• 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.

  PMID: 21856077 BACKGROUND

• 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.

  PMID: 12839406 BACKGROUND

• 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.

  PMID: 23538215 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Daniela Ap Biasotto-Gonzalez, PHD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DANIELA AP BIASOTTO-GONZALEZ, PHD

CONTACT

+55 11 36659325; dani_atm@ig.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: November 19, 2014
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

BR (1)