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

NCT ID: NCT04686084

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-26
• Study Completion Date: 2021-11-29

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.

Conditions

Dental Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CT scan

CT scan (MDCT, standard of care) and DE-CBCT (Investigational)

Group Type: EXPERIMENTAL

Dual-energy computed tomography scan

Intervention Type: DEVICE

Diagnostic CT scan

Interventions

Dual-energy computed tomography scan

Diagnostic CT scan

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Sanjay Mallya, BDS, MDS, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sanjay M Mallya, BDS,MDS,PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA School of Dentistry

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-001768

Identifier Type: -

Identifier Source: org_study_id