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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT scan | Experimental | CT scan (MDCT, standard of care) and DE-CBCT (Investigational) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-energy computed tomography scan | Device | Diagnostic CT scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Density Assessment | Bone density (g/cc) in a region of interest measured by the OnDemand software | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay M Mallya, BDS,MDS,PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Dentistry | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42082858 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT Scans | MDCT scan (Standard of care procedure, 1 scan) DE-CBCT (Investigational procedure, 1 scan) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT Scan | CT scan (MDCT, standard of care) and DE-CBCT (Investigational) Dual-energy computed tomography scan: Diagnostic CT scan |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Density Assessment | Bone density (g/cc) in a region of interest measured by the OnDemand software | Patients imaged with MDCT and DE-CBCT | Posted | Mean | Standard Deviation | g/cc | 30 days |
|
|
At time of study scan, up to 30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT Scan | CT scan (MDCT, standard of care) and DE-CBCT (Investigational) Dual-energy computed tomography scan: Diagnostic CT scan |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjay M Mallya | UCLA Oral & Maxillofacial Radiology | 3108251689 | smallya@dentistry.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 16, 2020 | Nov 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Participants |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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