## Protocol Section
### Identification Module
**NCT ID:** NCT04487379

**Brief Title:** Ultrasound Crestal Bone Topography of Edentulous Ridges

**Official Title:** Evaluation of Crestal Bone Topography of Edentulous Ridges: A Retrospective Study Comparing Ultrasonography to Cone-Beam Computed Tomography (CBCT)

#### Organization Study ID Info
**ID:** HUM00183733
#### Organization
**Class:** OTHER
**Full Name:** University of Michigan
### Status Module
#### Completion Date
**Date:** 2020-12-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-15

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-01

**Type:** ACTUAL

#### Start Date
**Date:** 2020-06-16

**Type:** ACTUAL

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2020-07-27
**Type:** ACTUAL
**Study First Submit Date:** 2020-07-17
**Study First Submit QC Date:** 2020-07-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Michigan

#### Responsible Party

**Investigator Affiliation:** University of Michigan

**Investigator Full Name:** Hsun-Liang Chan

**Investigator Title:** Clinical Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A successful implant surgery primarily relies on a prudent evaluation of oral anatomy and meticulous treatment planning. Additionally, of paramount importance that dictates the types of procedures, material selection and ultimately success of implant surgery is the quality and quantity of the edentulous ridge. Ultrasound imaging (US), another cross-sectional imaging modality, has been extensively used in the medical diagnostics field. The ability of ultrasound to image soft tissue-bone interface makes it particularly promising for studying bone ridge width and crestal bone topography. Therefore, this retrospective human study aimed to compare bone width measurements between US and CBCT. This study also investigated the possible correlation between the crestal bone surface quality imaged by US and CBCT.

### Conditions Module

**Conditions:**

- Ultrasonography

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 28

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This group had edentulous ridge planning to receive a dental implant and had ultrasound and cone-beam computed tomography images of the ridge.

**Label:** Group with edentulous ridge

### Outcomes Module

#### Primary Outcomes

**Description:** measure the edentulous ridge width at 1, 2 and 3 mm apical to the crest on ultrasound images

**Measure:** Accuracy of ultrasound for estimating ridge width

**Time Frame:** up to 3 months after image was taken

#### Secondary Outcomes

**Description:** Evaluate the crestal bone surface quality with ultrasound

**Measure:** Accuracy of ultrasound for assessing ridge surface quality

**Time Frame:** up to 3 months after image was taken

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient records at the Graduate Periodontal Clinic
* With both US and CBCT scans taking within 3 months between each other from Jan 2016 to Mar 2020
* These images had to include at least one edentulous ridge at the anterior, premolar or molar site.
* Multiple sites in a given patient may be included.

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Records of patients who had at least 1 edentulous ridge with a plan for implant placement, had cone-beam computed tomography as standard procedure and ultrasound imaging for off-label use of evaluating the ridge were included.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Ann Arbor

**Country:** United States

**Facility:** University of Michigan School of Dentistry

**State:** Michigan

**Zip:** 48109

### IPD Sharing Statement Module

**Description:** Not plan to share IPD.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000014076

- Term: Tooth Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12026

- Name: Mouth, Edentulous

- Relevance: HIGH

- As Found: Edentulous

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009066

- Term: Mouth, Edentulous

### Misc Info Module

- Version Holder: 2024-05-24
