Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Assessment of Jaw Bone Density
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|ClinicalTrials.gov Identifier: NCT04686084|
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : April 30, 2021
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|
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 (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: CT scan
CT scan (MDCT, standard of care) and DE-CBCT (Investigational)
Device: Dual-energy computed tomography scan
Diagnostic CT scan
- Bone density assessment [ Time Frame: 30 days ]Bone mineral density (g/cc) in a region of interest measured by the OnDemand software
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
|Contact: Sanjay M Mallyafirstname.lastname@example.org|
|United States, California|
|UCLA School of Dentistry||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Sanjay M Mallya, BDS, MDS, PhD 3108251689 email@example.com|
|Sub-Investigator: Tara Aghaloo, DDS, MD, PhD|
|Sub-Investigator: Sotirios Tetradis, DDS, PhD|
|Sub-Investigator: Reuben Kim, DDS, PhD|
|Principal Investigator:||Sanjay M Mallya, BDS, MDS, PhD||University of California, Los Angeles|