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

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

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

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 days

Population: Patients imaged with MDCT and DE-CBCT

Bone density (g/cc) in a region of interest measured by the OnDemand software

Outcome measures

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

Sanjay M Mallya

UCLA Oral & Maxillofacial Radiology

Phone: 3108251689

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place