Temporomandibular Disorders and Osteoporosis (TMDOST)

This study has been completed.
Sponsor:
Collaborator:
Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad
Information provided by (Responsible Party):
Alessandra Pucci Mantelli Galhardo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01029210
First received: December 8, 2009
Last updated: December 19, 2011
Last verified: November 2011
  Purpose

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
Women
Osteoporosis
Osteopenia
Temporomandibular Disorder

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Enrollment: 100
Study Start Date: May 2008
Study Completion Date: November 2011
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   48 Years to 70 Years
Genders 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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes
  • fibromyalgia
  • lupus, psoriases
  • rheumatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029210

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

Additional Information:
No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alessandra Pucci Mantelli Galhardo, Dr, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01029210     History of Changes
Other Study ID Numbers: CAPPesq 0175/08
Study First Received: December 8, 2009
Last Updated: December 19, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
osteoporosis
temporomandibular disorders
resonance magnetic

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

ClinicalTrials.gov processed this record on August 28, 2014