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WomenTMDOSTNCT01029210

Temporomandibular Disorders and Osteoporosis

An observational study of Women and Osteoporosis, run by University of Sao Paulo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 48 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Women, Osteoporosis, Osteopenia
How many people
100 participants
Where
No sites listed yet
Study dates
May 2008to Nov 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: patients attended by the discipline of gynecology - outpatient clinic of climatério

Who may be able to join

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

Who cannot join

  • diabetes
  • fibromyalgia
  • lupus, psoriases
  • rheumatic disease

About this study

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)

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.

Read the detailed description

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

Keywords
osteoporosis, temporomandibular disorders, resonance magnetic
Medical subject headings
Osteoporosis, Bone Diseases, Metabolic, Temporomandibular Joint Disorders

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2009 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2009
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Cross-sectional
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01029210
Sponsor's protocol ID
CAPPesq 0175/08
Acronym
TMDOST
Status last verified
Nov 2011
First submitted
8 Dec 2009
Last updated
20 Dec 2011
Results posted
No
Data monitoring committee
No

Publications

  • Galhardo AP, da Costa Leite C, Gebrim EM, Gomes RL, Mukai MK, Yamaguchi CA, Bernardo WM, Soares JM Jr, Baracat EC, Gil C. The correlation of research diagnostic criteria for temporomandibular disorders and magnetic resonance imaging: a study of diagnostic accuracy. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Feb;115(2):277-84. doi: 10.1016/j.oooo.2012.10.020.

    PubMed 23312922

Questions about this trial

What is this clinical trial studying?

An observational study of Women and Osteoporosis, run by University of Sao Paulo.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01029210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.

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