Trial record 54 of 171 for:
TMD/TMJ
Temporomandibular Disorders and Osteoporosis (TMDOST)
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| ClinicalTrials.gov Identifier: NCT01029210 |
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Recruitment Status :
Completed
First Posted : December 9, 2009
Last Update Posted : December 20, 2011
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Sponsor:
University of Sao Paulo
Collaborator:
Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad
Information provided by (Responsible Party):
Alessandra Pucci Mantelli Galhardo, University of Sao Paulo
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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 |
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| Women Osteoporosis Osteopenia Temporomandibular Disorder |
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
Criteria
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 ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
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 |
| 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:
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osteoporosis temporomandibular disorders resonance magnetic |
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders Temporomandibular Joint Dysfunction Syndrome Disease Osteoporosis 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 |