Trial Outcomes & Findings for Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Assessment of Jaw Bone Density (NCT NCT04686084)
NCT ID: NCT04686084
Last Updated: 2023-01-18
Results Overview
Bone density (g/cc) in a region of interest measured by the OnDemand software
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
26 participants
Primary outcome timeframe
30 days
Results posted on
2023-01-18
Participant Flow
Participant milestones
| Measure |
CT Scans
MDCT scan (Standard of care procedure, 1 scan) DE-CBCT (Investigational procedure, 1 scan)
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
CT Scans
MDCT scan (Standard of care procedure, 1 scan) DE-CBCT (Investigational procedure, 1 scan)
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CT Scan
n=25 Participants
CT scan (MDCT, standard of care) and DE-CBCT (Investigational)
Dual-energy computed tomography scan: Diagnostic CT scan
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: Patients imaged with MDCT and DE-CBCT
Bone density (g/cc) in a region of interest measured by the OnDemand software
Outcome measures
| Measure |
CT Scan
n=25 Participants
CT scan (MDCT, standard of care)
|
DE-CBCT Scan (Investigational)
n=25 Participants
Patients imaged with the dual energy CBCT scan
|
|---|---|---|
|
Bone Density Assessment
|
0.48 g/cc
Standard Deviation 0.31
|
0.46 g/cc
Standard Deviation 0.36
|
Adverse Events
CT Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place