Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Assessment of Jaw Bone Density

Dental Diseases Clinical Trial

Official title:

A Clinical Trial to Evaluate the Effectiveness and Safety of Dual Energy Cone-Beam Computed Tomography (DE-CBCT) Imaging for Quantitative Measurement of Jaw Bone Density

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686084
• Other study ID #: 20-001768
• Status: Completed
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: November 29, 2021

Study information

• Verified date: December 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 29, 2021
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Diseases
• Stomatognathic Diseases

Intervention

Device:
• Dual-energy computed tomography scan
Diagnostic CT scan

Locations

Country	Name	City	State
United States	UCLA School of Dentistry	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Density Assessment	Bone density (g/cc) in a region of interest measured by the OnDemand software	30 days