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

May 18, 2026 updated by: Sanjay Mallya, BDS, MDS, PhD, University of California, Los Angeles

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CT scan
CT scan (MDCT, standard of care) and DE-CBCT (Investigational)
Device: Dual-energy computed tomography scan
Diagnostic CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone Density Assessment
Time Frame: 30 days
Bone density (g/cc) in a region of interest measured by the OnDemand software
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Sanjay M Mallya, BDS,MDS,PhD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

November 29, 2021

Study Completion (Actual)

November 29, 2021

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-001768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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