Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography

NCT02303340 | Unknown

• 1 other identifier: sor 0130-13-ctil
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography (CBCT) in assessment of bone density. The study population contains men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner. Any patient (eligible for bone density screening by age criteria) undergoing CBCT of either one of the jaws (or both) due to dental reasons, will be sent to a bone mineral density DEXA Scan, and for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels. Density measurements will be done in specific sites on the CBCT's of the jaws. These measurements will be correlated with the blood tests and DEXA scan results.

Conditions

Osteoporosis

Keywords

Cone Beam Computed Tomography; Para Thyroid Hormone; Dual Energy X-ray Absorptiometry; Digital Imaging and Communication in Medicine

Outcome Measures

Primary Outcomes (1)

• Number of participants that have Osteoporosis that was shown on the dental CT and the DEXA exams

  12 months

Secondary Outcomes (1)

• Association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs

  12 months

Study Arms (1)

Study Group

Any patient who enrolled and signed informed consent will be sent to bone mineral density DEXA Scan, and for blood testing for PTH, Phosphor, Calcium ,Vitamin D and Creatinine levels. Density measurements will be done in specific sites on the CBCT's of the jaws.

Radiation: Dual Energy X-ray Absorptiometry

Interventions

Dual Energy X-ray Absorptiometry RADIATION

Also known as: DEXA

Study Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women above the age of 60 years, eligible for Bone Density Testing in accordance with their health insurance, who underwent a Dental CBCT recommended by their Dental Practitioner.

You may qualify if:

• Men and women above the age of 60 years.
• Underwent Dental Cone Beam Tomography for dental reasons, up to three months before screening.
• Patients underwent bone density examination at Soroka Medical Center only, during the last year prior commencing the research will be eligible for participation without the need for an additional bone density scanning.

You may not qualify if:

• Patients with current or past treatment of any osteoporotic medication: Alendronate (Alendronate teva, Fosamax, Maxibone , Fosalan, Fosavance), Residronate (Actonel. Ribone), Zoledronic acid (Aclasta, Zomera), Denosumab (Prolia), Teriperatide (Forteo),Raloxifen ( Evista), Stronsium Ranelate (Protelos).
• Patients taking Corticosteroid Therapy.
• Patients with history of Head and Neck Neoplasia or Head and Neck Irradiation or Bone Metastasis.
• Patients with hard tissue pathology of the jaws.
• Patients after laminectomy and or fixation of lumbar vertebrae or after bilateral hip replacement.
• Diagnosis of primary hyperparathyroidism.

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

Soroka University Medical Center

Beersheba, Israel

RECRUITING

Related Publications (10)

• Lindsay R, Cosman F. Chapter 354. Osteoporosis. In: Longo DL, Fauci AS, Kasper DL, Hauser SL, Jameson JL, Loscalzo J, eds. Harrison's Principles of Internal Medicine. 18th ed. New York: McGraw-Hill; 2012.

  BACKGROUND

• Scarfe WC, Farman AG, Sukovic P. Clinical applications of cone-beam computed tomography in dental practice. J Can Dent Assoc. 2006 Feb;72(1):75-80.

  PMID: 16480609 BACKGROUND

• Valiyaparambil JV, Yamany I, Ortiz D, Shafer DM, Pendrys D, Freilich M, Mallya SM. Bone quality evaluation: comparison of cone beam computed tomography and subjective surgical assessment. Int J Oral Maxillofac Implants. 2012 Sep-Oct;27(5):1271-7.

  PMID: 23057044 BACKGROUND

• Padbury AD Jr, Tozum TF, Taba M Jr, Ealba EL, West BT, Burney RE, Gauger PG, Giannobile WV, McCauley LK. The impact of primary hyperparathyroidism on the oral cavity. J Clin Endocrinol Metab. 2006 Sep;91(9):3439-45. doi: 10.1210/jc.2005-2282. Epub 2006 Jul 5.

  PMID: 16822829 BACKGROUND

• Hastar E, Yilmaz HH, Orhan H. Evaluation of mental index, mandibular cortical index and panoramic mandibular index on dental panoramic radiographs in the elderly. Eur J Dent. 2011 Jan;5(1):60-7.

  PMID: 21228957 BACKGROUND

• Neves FS, Oliveira LS, Torres MG, Toralles MB, da Silva MC, Campos MI, Campos PS, Crusoe-Rebello I. Evaluation of panoramic radiomorphometric indices related to low bone density in sickle cell disease. Osteoporos Int. 2012 Jul;23(7):2037-42. doi: 10.1007/s00198-011-1810-z. Epub 2011 Oct 18.

  PMID: 22006042 BACKGROUND

• Taguchi A. Triage screening for osteoporosis in dental clinics using panoramic radiographs. Oral Dis. 2010 May;16(4):316-27. doi: 10.1111/j.1601-0825.2009.01615.x. Epub 2009 Aug 7.

  PMID: 19671082 BACKGROUND

• Halling A, Persson GR, Berglund J, Johansson O, Renvert S. Comparison between the Klemetti index and heel DXA BMD measurements in the diagnosis of reduced skeletal bone mineral density in the elderly. Osteoporos Int. 2005 Aug;16(8):999-1003. doi: 10.1007/s00198-004-1796-x. Epub 2004 Dec 17.

  PMID: 15605191 BACKGROUND

• Mah P, Reeves TE, McDavid WD. Deriving Hounsfield units using grey levels in cone beam computed tomography. Dentomaxillofac Radiol. 2010 Sep;39(6):323-35. doi: 10.1259/dmfr/19603304.

  PMID: 20729181 BACKGROUND

• Romme EA, Murchison JT, Phang KF, Jansen FH, Rutten EP, Wouters EF, Smeenk FW, Van Beek EJ, Macnee W. Bone attenuation on routine chest CT correlates with bone mineral density on DXA in patients with COPD. J Bone Miner Res. 2012 Nov;27(11):2338-43. doi: 10.1002/jbmr.1678.

  PMID: 22692725 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Joshuah Ben Zion, MD

CONTACT

972-52-4226400; BenzionJ@clalit.org.il

Rita Troitsa, BA

CONTACT

972-52-8020985; ritatr@clalit.org.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Otolaryngology Department

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 27, 2014
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

IL (1)