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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686084
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
Sanjay Mallya, BDS, MDS, PhD, University of California, Los Angeles

Study Description
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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.


Condition or disease Intervention/treatment Phase
Dental Diseases Device: Dual-energy computed tomography scan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : March 26, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Bone density assessment [ Time Frame: 30 days ]
    Bone mineral density (g/cc) in a region of interest measured by the OnDemand software


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686084


Contacts
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Contact: Sanjay M Mallya 3108255634 smallya@dentistry.ucla.edu

Locations
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United States, California
UCLA School of Dentistry Recruiting
Los Angeles, California, United States, 90095
Contact: Sanjay M Mallya, BDS, MDS, PhD    3108251689    smallya@dentistry.ucla.edu   
Sub-Investigator: Tara Aghaloo, DDS, MD, PhD         
Sub-Investigator: Sotirios Tetradis, DDS, PhD         
Sub-Investigator: Reuben Kim, DDS, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Sanjay M Mallya, BDS, MDS, PhD University of California, Los Angeles
More Information
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Responsible Party: Sanjay Mallya, BDS, MDS, PhD, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04686084    
Other Study ID Numbers: 20-001768
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: April 30, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sanjay Mallya, BDS, MDS, PhD, University of California, Los Angeles:
cone beam computed tomography, dual-energy CT
Additional relevant MeSH terms:
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Stomatognathic Diseases