Dental Diseases
Conditions
Keywords
cone beam computed tomography, dual-energy CT
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.
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.
Interventions
DEVICEDual-energy computed tomography scan
Diagnostic CT scan
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone Density Assessment | 30 days | Bone density (g/cc) in a region of interest measured by the OnDemand software |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSanjay M Mallya, BDS,MDS,PhD
University of California, Los Angeles
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT Scan CT scan (MDCT, standard of care) and DE-CBCT (Investigational)
Dual-energy computed tomography scan: Diagnostic CT scan | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | CT Scan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Bone Density Assessment
Bone density (g/cc) in a region of interest measured by the OnDemand software
Time frame: 30 days
Population: Patients imaged with MDCT and DE-CBCT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT Scan | Bone Density Assessment | 0.48 g/cc | Standard Deviation 0.31 |
| DE-CBCT Scan (Investigational) | Bone Density Assessment | 0.46 g/cc | Standard Deviation 0.36 |