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NCT number NCT03304743
Study type Interventional
Source University of Parma
Contact Elena Calciolari, DDS, MS, PhD
Phone +39 0521906700
Email e.calciolari@qmul.ac.uk
Status Not yet recruiting
Phase N/A
Start date November 1, 2017
Completion date September 2018

Clinical Trial 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.

This study aims to test if it is meaningful to use OPGs to screen for post-menopausal osteoporosis. In particular, it will inform on how many undiagnosed osteoporotic women attend a Dental Hospital, how willing they are to have a DXA scan after a dental appointment and how precise the OPGs are as screening tools.

124 post-menopausal women will be recruited, which will undergo an OPG and a DXA scan to check their bone density.


Clinical Trial 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.

Amongst the quantitative indices, the most adopted ones are the mandibular cortical width (MCW) and the panoramic mandibular index (PMI). The MCW represents the width of the mandibular cortex and it is measured in the mental foramen region, along a line passing through the middle of the mental foramen and perpendicular to the tangent to the lower border of the mandible. The PMI represents the ratio between the mandibular cortical width at mental foramen region and the distance from the lower border to the inferior edge of the mental foramen.

Amongst the qualitative indices, the Klemetti index (KI) is by far the most applied one. KI qualitatively classifies the mandibular cortex distally to the mental foramen in the following categories: C1, when the endosteal margin is even and sharp; C2, when the endosteal margin presents lacunar resorption or cortical residues on one or both sides; and C3, when the cortical layer is clearly porous, with heavy endosteal cortical residues. A recent systematic review and meta-analysis from our group showed that the presence of any kind of cortical porosity (C2+C3) is associated to a sensitivity and specificity in detecting osteoporosis of 80.6% and 64.3%, respectively. The advantage of using this index, compared to other available indices, is that it is straightforward and relatively easy to measure and it does not require specific softwares.

It is clear that the panoramic indices cannot replace the diagnosis of osteoporosis by BMD measurement with DXA scan. However, whenever a panoramic radiograph is available, they might be opportunistically used to detect previously undiagnosed osteoporotic patients and refer them to a specialist before they develop a 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.

Study description:

This is a feasibility study designed as a cross-sectional study aiming to recruit a cohort of 124 consecutive post-menopausal women. Participants will be recruited from the "Centro Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma". Leaflets advertising the study and giving contact points will be placed in the "Centro Malattie Osteometaboliche", in the "Centro Universitario di Odontoiatria" and will be sent to the General Practitioners of Parma.

Before enrolment, written and verbal information will be given to the patients and written informed consent will be obtained.

Study visits include enrolment (Visit 1) and DXA scan (Visit 2).

1.1 Visit 1 (Enrolment)

- Signing of informed consent;

- Recording of any concomitant medication;

- Confirmation of participant eligibility in relation to the inclusion/exclusion criteria;

- Examination of hard and soft tissues;

- Full-mouth six-points pocket chart, with recording of probing pocket depth (PPD), recession (REC), furcation involvement and mobility. The results of the dental and periodontal examination will be explained to the patients. The trial will not cover the expenses for any treatment the patients might need.

- Dental panoramic radiograph (if not performed within the previous 6 months at Centro Universitario di Odontoiatria)

1.2 Visit 2 (DXA scan) (within 6 months from enrolment)

- DXA scan at lumbar spine and hip at "Centro Osteoporosi e malattie metaboliche scheletriche" (if not performed within the previous 6 months)

Photos of the teeth may be taken to facilitate case documentation. Subjects will not be identifiable.

At the end of visit 2, two examiners blinded to the DXA results will independently measure the panoramic indices on the OPGs. In particular, for the KI, the level of mandibular cortical erosion in the mental foramen region will be qualitatively evaluated after zooming the OPG and optimization of the image contrast and white balance.

The MCW and PMI will be measured with the digital software provided by ORTHOPHOS XG 3D.

After at least 1 week, the examiners will repeat the measurements in 20% of the OPGs, in order to evaluate intra- and inter- examiner reproducibility.


Study Design


Related Conditions & MeSH terms


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