Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography

March 15, 2016 updated by: Ben-Zion Joshua, Soroka University Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheva, Israel
        • Recruiting
        • Soroka University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other Names:
  • DEXA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants that have Osteoporosis that was shown on the dental CT and the DEXA exams
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between bone density DEXA results, blood tests for Calcium, Phosphor, PTH and Vitamin D and Bone density measurements on Dental CBCTs
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (ESTIMATE)

November 27, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sor 0130-13-ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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