Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography

Osteoporosis Clinical Trial

Official title:

Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02303340
• Other study ID #: sor 0130-13-ctil
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2014
• Last updated: March 15, 2016
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Soroka University Medical Center
• Contact: Joshuah Ben Zion, MD
• Phone: 972-52-4226400
• Email: BenzionJ[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

Description:

The purpose of this study is to elucidate the role of Dental Cone Beam Computed Tomography 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 dual energy x-ray absorptiometry (DEXA) Scan, and for blood testing for parathormone (PTH), Phosphor, Calcium ,Vitamin D and Creatinine levels.

The investigators estimate thousands of Dental Cone Beam Computed Tomographies are being ordered every year, due to dental needs in Israel. In this preliminary prospective pilot study the investigators will evaluate 50 subjects who underwent both Dental CBCT and DEXA scan as a preliminary testing.

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.

The outcomes of this study are:

1. Bone density measurement on Dental CBCT can be used for diagnosis of low bone mass conditions.

2. There is an association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Men and women above the age of 60 years.

2. Underwent Dental Cone Beam Tomography for dental reasons, up to three months before screening.

3. 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.

Exclusion Criteria:

1. 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).

2. Patients taking Corticosteroid Therapy.

3. Patients with history of Head and Neck Neoplasia or Head and Neck Irradiation or Bone Metastasis.

4. Patients with hard tissue pathology of the jaws.

5. Patients after laminectomy and or fixation of lumbar vertebrae or after bilateral hip replacement.

6. Diagnosis of primary hyperparathyroidism.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Radiation:
• Dual Energy X-ray Absorptiometry

Locations

Country	Name	City	State
Israel	Soroka University Medical Center	Beer Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (10)

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. Epub 2004 Dec 17. — View Citation

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. — View Citation

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.

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. — View Citation

Neves FS, Oliveira LS, Torres MG, Toralles MB, da Silva MC, Campos MI, Campos PS, Crusoé-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. — View Citation

Padbury AD Jr, Tözüm 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. Epub 2006 Jul 5. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that have Osteoporosis that was shown on the dental CT and the DEXA exams		12 months	No
Secondary	Association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs		12 months	No

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