A pivotal clinical trial for measuring bone mineral density using DE-CBCT images

A single site, randomized, crossover, pivotal clinical trial to evaluate the effectiveness and safety of measurement for maxilla and mandible bone mineral density using Dual Energy Cone Beam Computed Tomography (DE-CBCT) images

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004747

Enrollment

Registered

2020-02-19

Start date

2020-01-15

Completion date

Unknown

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device, Radiation : 1) Maxilla or mandible scan using DE-CBCT 2) Maxilla or mandible scan using QCT * The difference between two groups: imaging sequence of two devices

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Healthy male or female patients aged 19 to 84 years ? Patients who require dental intervention such as implant placement ? Patients who voluntarily signed the Informed Consent Form

Exclusion criteria

Exclusion criteria: ? Pregnancy or lactation ? Patients who had a CT scan the day before or on the day of the study ? Patients who cannot read, write or have cognitive impairment ? Patients who are not fit for this clinical trial as judged by the researcher

Design outcomes

Primary

Measure	Time frame
The difference between bone density values assessed by DE-CBCT and QCT (Accuracy)	—

Secondary

Measure	Time frame
Correlation between bone density values of QCT and DE-CBCT;The agreement between the evaluators	—

Countries

Korea, Republic of

Contacts

Public ContactSeo Yoon Kim

Seoul National University

Outcome results