Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Parma
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- sensitivity and specificity of Klemetti Index
Study Overview
Brief Summary
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.
Detailed Description
Background:
The World Health Organization (WHO) has defined osteoporosis as a level of bone mineral density (BMD), calculated with DXA (Dual-energy X-ray absorptiometry) technique, 2.5 standard deviations (SD) or more below the average mean value of young healthy women (T-score ≤ -2.5) (Kanis et al., 2013).
Although the WHO reports that there is indirect evidence supporting screening programs in women aged 65 or older, current Italian national guidelines do not recommend population-screening programs for osteoporosis (SIOMMMS 2015). As a consequence, a significant part of Italian osteoporotic patients that may develop a fracture is left undetected and untreated. Although it is recommended to assess risk of osteoporotic fractures with the WHO FRAX tool in all women ≥65 years and men ≥75 years and refer for DXA accordingly, it is not clear how well this tool has been adopted by general practitioners (GPs) in Italy.
Considering the high percentage of people attending regular dental visits (> 22 million according to ISTAT 2013) and the fact that panoramic radiographs of the jawbones are a common procedure that is performed during routine dental check-ups or before several dental treatments, it could be of great clinical value if dentists could opportunistically use panoramic X-rays to identify patients at a high risk of osteoporosis.
In the past years, specific quantitative and qualitative indices/parameters, which can be calculated on dental panoramic radiographs, have been proposed as tools to detect osteoporosis, with different levels of accuracy.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •≥ 65 years old
- •In self-reported menopause, defined as the permanent cessation of ovulation, for at least one year (Soules et al., 2001).
- •With a DXA examination at the hip and lumbar spine performed within the previous 12 months
Exclusion Criteria
- •Affected by systemic diseases (with the exception of osteoporosis) recognized to severely affect bone metabolism (e.g. Cushing's syndrome, Addison's disease, diabetes mellitus type 1, leukaemia, pernicious anaemia, malabsorption syndromes, chronic liver disease, rheumatoid arthritis).
- •Knowingly affected by HIV or viral hepatitis.
- •History of local radiation therapy in the last five years.
- •Affected by limited mental capacity or language skills such that study information cannot be understood, informed consent cannot be obtained, or simple instructions cannot be followed.
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality which may increase the risk associated with trial participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- sensitivity and specificity of mandibular cortical width(12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement)
- number of osteoporotic women identified as osteoporotic with the help of panoramic indices and their risk of fractures(At study completion, up to 18 months from the beginning of the study)
- sensitivity and specificity of panoramic mandibular index(12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement)
- Precision and reproducibility of Klemetti index(12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement)
- 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(up to 18 months)
Investigators
Dr Elena Calciolari
Dr, MS, Phd, Clinical Research Fellow
University of Parma