Trial record 54 of 171 for:    TMD/TMJ

Temporomandibular Disorders and Osteoporosis (TMDOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01029210
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : December 20, 2011
Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad
Information provided by (Responsible Party):
Alessandra Pucci Mantelli Galhardo, University of Sao Paulo

Brief Summary:
Increased life expectancy has attracted research attention, interested in provide a quality and healthy aging. According to the latest census conducted in 2010 by IBGE, Brazilian population consists of 97,342,162 women, whom estimates 30 million are between 40 and 65 years old, a period that includes the climacteric. Therefore, clinical conditions such as osteoporosis becomes significant, either from public health policy standpoint or in relation to the social aspect, by compromising life quality. Women also suffer more from temporomandibular disorders (TMD) than men, and the beginning of this situation occurs after puberty, with peaks during the reproductive and remission periods after menopause. Female sex hormones involvement in osteoporosis is well established, but their participation in the TMD is still controversial. Thus, this study aims to investigate the role of systemic bone mass in menopausal women as a risk factor for articular TMD, as well as the TMD pain behavior during menopause transition periods (48 to 55 years), postmenopausal (56-65 years) and senescence (65-70 years). Therefore, 100 women attended by the HC - FMUSP Gynecology Division, Climacteric Sector, were clinically evaluated by the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), used to obtain diagnoses and their associations, as well as to quantify the TMD pain sensitivity degree through the Craniomandibular Index (CMI), both applied by a single examiner. The bone densitometry provided bone mass data of femoral neck and lumbar spine (L1-L4). The RDC/TMD performance as a diagnostic test also was subjected to analysis, considering the 3.0 Tesla magnetic resonance imaging as reference standard, undergoing 30 women, of 100 assessed, in this imaging exam. After analyzing the results, it was shown that the risk posed by osteopenia was 1.33 (IC95% 1.20 - 1.46), with a risk increase of 0.33, while the risk of osteoporosis showed 1.39 (IC95% 1,20 - 1.23 to 1.55), increased by 0.39. Joint diagnoses predominated (68.0%), while 18.0% muscular diagnoses and 14.0% corresponds to the absence of clinically diagnosable conditions, according to the RDC/TMD. The performance of the RDC/TMD to diagnose articular DTM revealed accuracy of 68.0%, sensitivity of 83.0%, specificity 53.0%, pre-test probability of 52.0%, positive predictive value of 60.0 % and negative 74.0%, positive likelihood ratio of 1.77 and negative 0.32. As for the soreness sensibility in TMD, it was found that aging shows a clear tendency towards its reduction (A =- 4.5, p = 0.0324). Then, the study concluded that the decrease in female sex hormones, peculiar to aging, increases the risk of articular TMD, although this pain disfunction decreases with age. The RDC/TMD can be used for large populations screening, but its indication in clinical practice should be done with caution.

Condition or disease
Women Osteoporosis Osteopenia Temporomandibular Disorder

Detailed Description:
Osteoporosis and temporomandibular disorders are diseases which attack mainly women. Then, this research aims at if if they are related.

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Temporomandibular Disorders in Climacteric Women: Pain Sensibility, Risk Posed by Systemic Bone Mass and Diagnostic Made by RDC/TMD Compared to MRI (3.0 Tesla)
Study Start Date : May 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : November 2011

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Ages Eligible for Study:   48 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients attended by the discipline of gynecology - outpatient clinic of climatério

Inclusion Criteria:

  • women
  • age between 48 and 70 years old
  • densitometry bone actual

Exclusion Criteria:

  • diabetes
  • fibromyalgia
  • lupus, psoriases
  • rheumatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01029210

Sponsors and Collaborators
University of Sao Paulo
Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad
Principal Investigator: Alessandra Galhardo University of Sao Paulo

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alessandra Pucci Mantelli Galhardo, Dr, University of Sao Paulo Identifier: NCT01029210     History of Changes
Other Study ID Numbers: CAPPesq 0175/08
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: November 2011

Keywords provided by Alessandra Pucci Mantelli Galhardo, University of Sao Paulo:
temporomandibular disorders
resonance magnetic

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Bone Diseases, Metabolic
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes