Ultrasonography and Cone-Beam Computed Tomography for Peri-implant Tissue Evaluation

NCT04488302 | Completed

• 1 other identifier: HUM00179671
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Although cone-beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. The aim of present study was to demonstrate the complementary role of ultrasound (US), for a comprehensive examination of peri-implant tissues in live humans. Material and Methods: Patients with \> 1 implant, a CBCT scan, an US scan, and clinical photographs taken during the open-bone surgery were included. The crestal bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct FBL measurements were also made on clinical images. The correlation plots were made to evaluate the measurement agreements between the 3 methods.

Conditions

Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Crestal bone thickness

  facial bone thickness measured at 1 mm apical to bone crest

  up to 100 months after implant surgery.

Secondary Outcomes (1)

• Facial bone height

  up to 100 months after implant surgery.

Study Arms (1)

Implant group

Patients with 1 or more implants with CBCT, ultrasound and open-bone images

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

See eligibility criteria

You may qualify if:

• the patients had to have ≥ 1 implant with a CBCT scan, US scan, and clinical photographs taken during the surgery, e.g. a revision/explantation surgery due to peri-implantitis or a 2nd stage uncover surgery.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 27, 2020
• Study Start: November 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: July 7, 2020
• Last Updated: April 13, 2026

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)