Temporomandibular Disorders and Osteoporosis

NCT ID: NCT01029210

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Women Osteoporosis Osteopenia Temporomandibular Disorder

Keywords

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osteoporosis temporomandibular disorders resonance magnetic

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* diabetes
* fibromyalgia
* lupus, psoriases
* rheumatic disease
Minimum Eligible Age

48 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Instituto de Radiologia do Hospital das ClĂ­nicas da FMUSP - InRad

UNKNOWN

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Alessandra Pucci Mantelli Galhardo

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alessandra Galhardo

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 23312922 (View on PubMed)

Related Links

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Other Identifiers

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CAPPesq 0175/08

Identifier Type: -

Identifier Source: org_study_id