NCT04686084

Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Assessment of Jaw Bone Density

A Clinical Trial to Evaluate the Effectiveness and Safety of Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Imaging for Quantitative Measurement of Jaw Bone Density

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Current radiologic imaging modalities used in dentistry provide information on the morphology of the hard tissues. Additional information on the density of bone has practical relevance, for example, in dental implant treatment planning, where local bone quality is a known strong predictor of successful implant osseointegration. The Dual-Energy Cone Beam Computed Tomography (DE-CBCT) device is designed to overcome limitations of traditional imaging and will provide assessment of jaw bone density in additional to morphological information. This clinical trial will examine the application of DE-CBCT to assess jaw bone density and compare Hounsfield units (HU) values with multidetector CT, an established standard for assessing BD.

Detailed description

This is a single center, open-label trial, designed to enroll 24 patients. Both, the researcher and the subject know the treatment the participant is receiving. To evaluate the effectiveness and safety of DE-CBCT to evaluate jaw bone density and compare HU values with those of multidetector CT, an established standard for assessing BD. The study is based on two visits (VISIT 1 and VISIT 2) • DAY 0 (enrollment): Subject is queried for inclusion/exclusion criteria and informed about the study. If he/she agrees to participate, inclusion/exclusion criteria and informed consent will be documented. An imaging stent, which bears radiopaque markers, will be also created for each patient. • VISIT 1: Inclusion/exclusion criteria will be reconfirmed and the DE-CBCT imaging will be completed. • VISIT 2 (no more than 30 days since the enrollment): Inclusion/exclusion criteria will be reconfirmed and MDCT imaging completed. \- Depending on availability of scheduling on MDCT unit, Visit 2 may occur on the same day as Visit 1.

Conditions

• Dental Diseases

Interventions

Type	Name	Description
DEVICE	Dual-energy computed tomography scan	Diagnostic CT scan

Timeline

• Start date: 2021-03-26
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2020-12-28
• Last updated: 2023-01-18
• Results posted: 2023-01-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study