Clinical trial NCT01029210: Temporomandibular Disorders and Osteoporosis
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Women
Osteoporosis
Osteopenia
Temporomandibular Disorder
Keywords: osteoporosis
temporomandibular disorders
resonance magnetic
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad
First posted: 2009-12-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 48
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients attended by the discipline of gynecology - outpatient clinic of climatério

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* diabetes
* fibromyalgia
* lupus, psoriases
* rheumatic disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Alessandra Galhardo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.