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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
Sponsor:
Collaborator:
Queen Mary University of London
Information provided by (Responsible Party):
Dr Elena Calciolari, University of Parma

Tracking Information
First Submitted Date September 21, 2017
First Posted Date October 9, 2017
Last Update Posted Date October 12, 2018
Actual Study Start Date June 12, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 9, 2018)
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
Original Primary Outcome Measures
 (submitted: October 6, 2017)
sensitivity and specificity of Klemetti Index [ Time Frame: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
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
Change History Complete list of historical versions of study NCT03304743 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 9, 2018)
  • 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"
Original Secondary Outcome Measures
 (submitted: October 6, 2017)
  • sensitivity and specificity of mandibular cortical width [ Time Frame: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
    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: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
    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: At study completion (end of visit 2), so within 6 months from enrolment (visit 1) ]
    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 undiagnosed osteoporotic women [ Time Frame: during the 9 months of recruitment ]
    To record the number of undiagnosed post-menopausal osteoporotic women attending a University Dental Hospital (Centro Universitario di Odontoiatria)
  • number of osteoporotic women requiring treatment [ Time Frame: during the 9 months of recruitment ]
    To record the number of osteoporotic women identified as osteoporotic as part of the study that would require pharmacological treatment (based on the Italian modified version of FRAX "DeFRA", and on the Consultant Rheumatologist's advice)
  • % of post-menopausal women willing to be screened for osteoporosis after a dental appointment [ Time Frame: during the 9 months of recruitment ]
    This will be calculated as the percentage of post-menopausal women meeting the inclusion/exclusion criteria and willing to be screened for osteoporosis after a dental appointment (and therefore enrolled) out of all the patients approached.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis
Official Title Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis
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.

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 cross-sectional observational study aiming to recruit a cohort of 124 consecutive post-menopausal women. The only study visit will take place at the "Centro Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma".

All post-menopausal women ≥ 65 years old attending the Centro Universitario di Odontoiatria in the new patients' or follow-ups' clinics will be approached to check for the inclusion/exclusion criteria and their willingness to take part in the study. Furthermore, doctors (general practitioners or osteoporosis specialists) will be contacted and will be kindly asked to inform their patient that had done a DXA scan within the past 12 months about the study. Potentially eligible patients will be booked an appointment at the "Centro Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma" to check for inclusion/exclusion criteria and for the recruitment. As part of the study, they will receive a full-mouth examination of the hard and soft tissues and an OPG at no cost.

Only 1 study visit will be performed.

Visit 1 (Data collection)

  • 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 periodontal chart, with recording of probing pocket depth (PPD), recession (REC), furcation involvement and mobility.
  • Dental panoramic radiograph (OPG) if not performed at the Centro Universitario di Odontoiatria within the previous 12 months

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

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All post-menopausal women ≥ 65 years old attending the Centro Universitario di Odontoiatria in the new patients' or follow-ups' clinics will be approached to check for the inclusion/exclusion criteria and their willingness to take part in the study. Furthermore, doctors (general practitioners or osteoporosis specialists) will be contacted and will be kindly asked to inform their patient that had done a DXA scan within the past 12 months about the study. Potentially eligible patients will be booked an appointment at the "Centro Universitario di Odontoiatria, Dipartimento di Medicina e Chirurgia, Università di Parma" to check for inclusion/exclusion criteria and for the recruitment.
Condition Osteoporosis, Postmenopausal
Intervention 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.

Study Groups/Cohorts Post-menopausal women
A cohort of 124 consecutive post-menopausal women that performed a DXA scan within the previous 12 months
Intervention: Diagnostic Test: Dental panoramic radiograph
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 6, 2017)
124
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Women in menopause
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Elena Calciolari, DDS, MS, PhD +39 0521906700 e.calciolari@qmul.ac.uk
Contact: Federico Rivara, DDS, MS +39 0521906700 federivara@gmail.com
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03304743
Other Study ID Numbers P-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Information with regards to study participants will be kept confidential and data will be pseudo anonymised
Responsible Party Dr Elena Calciolari, University of Parma
Study Sponsor University of Parma
Collaborators Queen Mary University of London
Investigators
Principal Investigator: Elena Calciolari, DDS, MS, PHD University of Parma and Queen Mary University of London
PRS Account University of Parma
Verification Date October 2018