Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis (OsteoPano)
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|ClinicalTrials.gov Identifier: NCT03304743|
Recruitment Status : Recruiting
First Posted : October 9, 2017
Last Update Posted : October 12, 2018
Osteoporosis is a common disease that makes the bones fragile and easy to break. Osteoporotic fractures are a serious health problem resulting in pain, reduced mobility, increasing degree of dependence and sometimes death.
Osteoporosis is currently diagnosed by measuring bone density at the hip/spine through an exam called DXA. Although all post-menopausal women are at higher risk, currently Italian national guidelines do not recommend population-screening programs. This leads to several cases not being identified before a fracture occurs.
Since dental panoramic radiographs (OPGs) are common procedures during dental check-ups or before dental treatments, it would be of great value if dentists could use them to identify people with unknown osteoporosis and early refer them to a specialist before they fracture.
While several studies support the use of panoramic indices, they have never been tested in an Italian University Hospital setting and in a study adequately powered and controlled for confounding variables.
The aim of this study is to assess the feasibility of using dental panoramic indices to screen for post-menopausal osteoporosis.
|Condition or disease||Intervention/treatment|
|Osteoporosis, Postmenopausal||Diagnostic Test: Dental panoramic radiograph|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||124 participants|
|Official Title:||Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis|
|Actual Study Start Date :||June 12, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
A cohort of 124 consecutive post-menopausal women that performed a DXA scan within the previous 12 months
Diagnostic Test: Dental panoramic radiograph
If not performed within the previous 12 months at the Centre of Dentistry, an OPG will be performed during enrolment visit.
OPGs are routine low-dose x-rays that are often performed during dental check-ups, follow-ups or before dental treatments (e.g. extractions, implant placement, etc.), as they allow the evaluation of both bone and dental structures of both jaws, the sinus and temporo-mandibular joints.
- sensitivity and specificity of Klemetti Index [ Time Frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]To assess the sensitivity and specificity of Klemetti Index (KI) to screen for osteoporosis in postmenopausal women attending the Centre of Dentistry at the University of Parma
- sensitivity and specificity of mandibular cortical width [ Time Frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]To assess the sensitivity and specificity of mandibular cortical width (MCW) to screen for osteoporosis in postmenopausal women
- sensitivity and specificity of panoramic mandibular index [ Time Frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]To assess the sensitivity and specificity of panoramic mandibular index (PMI) to screen for osteoporosis in postmenopausal women
- Precision and reproducibility of Klemetti index [ Time Frame: 12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement ]Two blind examiners will calculate the index twice (within at least one week from the first evaluation) and intra and inter examiner reproducibility will be assessed through Kappa statistics
- Number of post-menopausal women attending a University Dental Hospital (Centro Universitario di Odontoiatria) and identified as osteoporotic with the help of the panoramic indices [ Time Frame: up to 18 months ]
- number of osteoporotic women identified as osteoporotic with the help of panoramic indices and their risk of fractures [ Time Frame: At study completion, up to 18 months from the beginning of the study ]this will be calculated based on the Italian modified version of FRAX, "DeFRA"
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): NCT03304743
|Contact: Elena Calciolari, DDS, MS, PhD||+39 email@example.com|
|Contact: Federico Rivara, DDS, MS||+39 firstname.lastname@example.org|
|Centro Universitario di Odontoiatria||Recruiting|
|Contact: Elena Calciolari, DDS, MS, PhD +39 0521906700 email@example.com|
|Contact: Federico Rivara, DDS, MS +39 0521906700 firstname.lastname@example.org|
|Principal Investigator:||Elena Calciolari, DDS, MS, PHD||University of Parma and Queen Mary University of London|