Temporomandibular Disorders and Osteoporosis

Osteoporosis Clinical Trial

— TMDOST  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029210
• Other study ID #: CAPPesq 0175/08
• Status: Completed
• Phase: N/A
• First received: December 8, 2009
• Last updated: December 19, 2011
• Start date: May 2008
• Est. completion date: November 2011

Study information

• Verified date: November 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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. 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 48 Years to 70 Years

Eligibility

Inclusion Criteria:

• women

• age between 48 and 70 years old

• densitometry bone actual

Exclusion Criteria:

• diabetes

• fibromyalgia

• lupus, psoriases

• rheumatic disease

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteopenia
• Osteoporosis
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Women

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad

External Links

•   Link