Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography

NCT ID: NCT02303340

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Osteoporosis

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Dual Energy X-ray Absorptiometry

Intervention Type RADIATION

Interventions

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Dual Energy X-ray Absorptiometry

Intervention Type RADIATION

Other Intervention Names

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DEXA

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ben-Zion Joshua

MD, Otolaryngology Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Soroka University Medical Center

Beersheba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Joshuah Ben Zion, MD

Role: CONTACT

972-52-4226400

Rita Troitsa, BA

Role: CONTACT

972-52-8020985

Facility Contacts

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Rita Troitsa, BA

Role: primary

972-5-8020985

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 16480609 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23057044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16822829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21228957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22006042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19671082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15605191 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20729181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22692725 (View on PubMed)

Other Identifiers

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sor 0130-13-ctil

Identifier Type: -

Identifier Source: org_study_id

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