WomenTMDOSTNCT01029210
Temporomandibular Disorders and Osteoporosis
An observational study of Women and Osteoporosis, run by University of Sao Paulo.
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. Read more about this study
- Who is it for?
- Ages 48 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women, Osteoporosis, Osteopenia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2008to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients attended by the discipline of gynecology - outpatient clinic of climatério
Who may be able to join
- women
- age between 48 and 70 years old
- densitometry bone actual
Who cannot join
- diabetes
- fibromyalgia
- lupus, psoriases
- rheumatic disease
About this study
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)
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.
Read the detailed description
Osteoporosis and temporomandibular disorders are diseases which attack mainly women. Then, this research aims at if if they are related.
- Conditions
- Women, Osteoporosis, Osteopenia, Temporomandibular Disorder
- Keywords
- osteoporosis, temporomandibular disorders, resonance magnetic
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Temporomandibular Joint Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2009
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WomenStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad
- Responsible party
- Principal investigator, Alessandra Pucci Mantelli Galhardo, University of Sao Paulo
- Investigators
- Alessandra Galhardo, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029210
- Sponsor's protocol ID
- CAPPesq 0175/08
- Acronym
- TMDOST
- Status last verified
- Nov 2011
- First submitted
- 8 Dec 2009
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23312922
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01029210
- Acronym / sponsor ID
- TMDOST / CAPPesq 0175/08
- Conditions
- Women, Osteoporosis, Osteopenia, Temporomandibular Disorder
- Keywords
- osteoporosis, temporomandibular disorders, resonance magnetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Instituto de Radiologia do Hospital das Clínicas da FMUSP - InRad
- Study start
- May 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 9 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 48 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients attended by the discipline of gynecology - outpatient clinic of climatério
Key inclusion criteria (3 listed)
- women
- age between 48 and 70 years old
- densitometry bone actual
Key exclusion criteria (4 listed)
- diabetes
- fibromyalgia
- lupus, psoriases
- rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
- Derived from this study: PubMed 23312922Galhardo 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.
Related trials for Women
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessandra Galhardo principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Women and Osteoporosis, run by University of Sao Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.