Magnetic Ressonance Imaging of Temporomandibular Joint

Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

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

Первичные конечные точки

• Articular Disc Positioning (Measured by the Magnetic Ressonance Imaging) [Срок оценки: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.]

Вторичные конечные точки (3)

• Clinical Symptoms (Measured by END) [Срок оценки: 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) [Срок оценки: Baseline (day 1) and after 4 weeks of treatment performed 3 times a week.]
• Quality of life (Whoqol-bref) [Срок оценки: Baseline (day 1) and after 4 weeks of treatment (performed 3 times a week), 3 and 6 months follow up]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• University of Nove de Julho — São Paulo

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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 ran PMID 24083628

Идентификаторы

NCT: NCT02294799 · YEH1984

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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