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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Dental Diseases

Treatments: Device: Dual-energy computed tomography scan

Study type: Interventional

Funder types: Other

Identifiers

NCT04686084

20-001768

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

CT scan

Experimental group

Description:

CT scan (MDCT, standard of care) and DE-CBCT (Investigational)

Treatment:

Device: Dual-energy computed tomography scan