Dental Panoramic Radiographs to Screen for Post-menopausal Osteoporosis

NCT03304743 | Completed

• 1 other identifier: P-001
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis, Postmenopausal

Keywords

dental panoramic radiographs; osteoporosis; feasibility study

Outcome Measures

Primary Outcomes (1)

• sensitivity and specificity of Klemetti Index

  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

  12 months is the maximum time between DXA results and OPT results, so it is also the timing for this outcome measurement

Secondary Outcomes (5)

• 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

• 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

• 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

Study Arms (1)

Post-menopausal women

A cohort of 124 consecutive post-menopausal women that performed a DXA scan within the previous 12 months

Diagnostic Test: Dental panoramic radiograph

Interventions

Dental panoramic radiograph DIAGNOSTIC_TEST

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.

Post-menopausal women

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Women in menopause
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Parma: lead
• Queen Mary University of London: collaborator

Study Sites (1)

Centro Universitario di Odontoiatria

Parma, Italy

Location

Related Publications (6)

• Calciolari E, Donos N, Park JC, Petrie A, Mardas N. Panoramic measures for oral bone mass in detecting osteoporosis: a systematic review and meta-analysis. J Dent Res. 2015 Mar;94(3 Suppl):17S-27S. doi: 10.1177/0022034514554949. Epub 2014 Nov 3.

  PMID: 25365969 BACKGROUND

• Calciolari E, Donos N, Park JC, Petrie A, Mardas N. A systematic review on the correlation between skeletal and jawbone mineral density in osteoporotic subjects. Clin Oral Implants Res. 2016 Apr;27(4):433-42. doi: 10.1111/clr.12597. Epub 2015 Apr 12.

  PMID: 25864584 BACKGROUND

• Klemetti E, Kolmakov S, Kroger H. Pantomography in assessment of the osteoporosis risk group. Scand J Dent Res. 1994 Feb;102(1):68-72. doi: 10.1111/j.1600-0722.1994.tb01156.x.

  PMID: 8153584 BACKGROUND

• Benson BW, Prihoda TJ, Glass BJ. Variations in adult cortical bone mass as measured by a panoramic mandibular index. Oral Surg Oral Med Oral Pathol. 1991 Mar;71(3):349-56. doi: 10.1016/0030-4220(91)90314-3.

  PMID: 2011361 BACKGROUND

• Kanis JA, McCloskey EV, Johansson H, Cooper C, Rizzoli R, Reginster JY; Scientific Advisory Board of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) and the Committee of Scientific Advisors of the International Osteoporosis Foundation (IOF). European guidance for the diagnosis and management of osteoporosis in postmenopausal women. Osteoporos Int. 2013 Jan;24(1):23-57. doi: 10.1007/s00198-012-2074-y. Epub 2012 Oct 19.

  PMID: 23079689 BACKGROUND

• Horner K, Devlin H. The relationship between mandibular bone mineral density and panoramic radiographic measurements. J Dent. 1998 May;26(4):337-43. doi: 10.1016/s0300-5712(97)00020-1.

  PMID: 9611939 BACKGROUND

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elena Calciolari, DDS, MS, PHD

  University of Parma and Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, MS, Phd, Clinical Research Fellow

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 9, 2017
• Study Start: June 12, 2018
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)