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

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.

Inclusion criteria

• Patients who need x-ray imaging for dental treatment planning and/or diagnosis
• Males or females aged older than 21
• Can follow instructions to be positioned into the CT scanner
• Can remain physically immobile during the CT scan acquisition
• Voluntarily sign and date the informed consent

Exclusion criteria

• Pregnancy
• Patients who are unable to comprehend the risks of the study to provide informed consent
• Extensive dental restorations, maxillofacial prosthesis, or orthopedic hardware that likely may cause artifacts and degrade quality, as determined by the study radiologists