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

NCT04686084 | Completed Results FDA Device

• 1 other identifier: 20-001768
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Diseases

Keywords

cone beam computed tomography, dual-energy CT

Outcome Measures

Primary Outcomes (1)

• Bone Density Assessment

  Bone density (g/cc) in a region of interest measured by the OnDemand software

  30 days

Study Arms (1)

CT scan

EXPERIMENTAL

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

Device: Dual-energy computed tomography scan

Interventions

Dual-energy computed tomography scan DEVICE

Diagnostic CT scan

CT scan

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA School of Dentistry

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Venkateswaran V, Tiwari R, Aghaloo T, Kim R, Bezouglaia O, Mallya SM. A novel dual-energy cone beam computed tomography device for assessment of jaw bone density. Oral Radiol. 2026 May 4. doi: 10.1007/s11282-026-00928-4. Online ahead of print.

  PMID: 42082858 RESULT

MeSH Terms

Conditions

Stomatognathic Diseases

Results Point of Contact

• Title: Sanjay M Mallya
• Organization: UCLA Oral & Maxillofacial Radiology

smallya@dentistry.ucla.edu

3108251689

Study Officials

• Sanjay M Mallya, BDS,MDS,PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: March 26, 2021
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: June 4, 2026
• Results First Posted: January 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)