- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01029210
Temporomandibular Disorders and Osteoporosis (TMDOST)
19. december 2011 opdateret af: Alessandra Pucci Mantelli Galhardo, University of Sao Paulo
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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Osteoporosis and temporomandibular disorders are diseases which attack mainly women.
Then, this research aims at if if they are related.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
100
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
48 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
patients attended by the discipline of gynecology - outpatient clinic of climatério
Beskrivelse
Inclusion Criteria:
- women
- age between 48 and 70 years old
- densitometry bone actual
Exclusion Criteria:
- diabetes
- fibromyalgia
- lupus, psoriases
- rheumatic disease
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Alessandra Galhardo, University of Sao Paulo
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2008
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. november 2011
Datoer for studieregistrering
Først indsendt
8. december 2009
Først indsendt, der opfyldte QC-kriterier
8. december 2009
Først opslået (Skøn)
9. december 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. december 2011
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. december 2011
Sidst verificeret
1. november 2011
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Metaboliske sygdomme
- Ledsygdomme
- Muskuloskeletale sygdomme
- Muskelsygdomme
- Stomatognatiske sygdomme
- Knoglesygdomme
- Kæbesygdomme
- Kraniomandibulære lidelser
- Mandibular sygdomme
- Myofasciale smertesyndromer
- Sygdom
- Osteoporose
- Temporomandibulære ledlidelser
- Temporomandibulært leddysfunktionssyndrom
- Knoglesygdomme, metaboliske
Andre undersøgelses-id-numre
- CAPPesq 0175/08
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