Diagnosis of Decreased Bone Density by Dental Cone Beam Computed Tomography

• Conditions: Osteoporosis
• Interventions: Radiation: Dual Energy X-ray Absorptiometry

• Registration Number: NCT02303340
• Lead Sponsor: Soroka University Medical Center

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.

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 Timeline

• Study First Submitted: 2014-11-20
• Study First Submitted QC: 2014-11-24
• Study First Posted: 2014-11-27
• Study Start: 2015-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-15
• Last Update Posted: 2016-03-16
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Dual Energy X-ray Absorptiometry	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.

Primary Outcome Measures

Name	Time	Method
Number of participants that have Osteoporosis that was shown on the dental CT and the DEXA exams	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Soroka University Medical Center; 🇮🇱 Beer Sheva, Israel