Ultrasound for Socket Healing Evaluation | NCT06017193

Studies
Ultrasound for Socket Healing Evaluation

NCT06017193

Sponsor

University of Michigan

Status

Recruiting

Last Update Posted

Oct 31, 2025Actual

Enrollment

140Estimated

Phase

Not provided

Conditions

Healing Wound
Alveolar; Wound
Alveolar Bone Loss
Image
Dent Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01DE030872	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Oct 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 25, 2024Actual

Primary Completion Date

Jul 1, 2027Estimated

Completion Date

Jul 1, 2027Estimated

First Submitted Date

Aug 1, 2023

First Submission Date that Met QC Criteria

Aug 23, 2023

First Posted Date

Aug 30, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2025

Last Update Posted Date

Oct 31, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oliver Kripfgans, Associate Professor, University of MichiganPrincipal Investigator

Lead Sponsor

University of MichiganOTHER

Collaborators

Name	Class
National Institute of Dental and Craniofacial Research (NIDCR)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The design is a single blinded, dual comparative study of ultrasound versus micro-CT/LASCA in one study group. Up to a total of 140 subjects registered will be recruited. Subjects who are treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft and are planned for a dental implant surgery. Qualified subjects will be asked during their pre-assessment visit. Subjects will be scanned with ultrasound and LASCA among other assessments shown in the info-graph and schedule of events. At the day of tooth extraction and socket augmentation (graft placement), clinical exams/measurements are taken, along with other research activities described in the info-graph and schedule of events. Recovery (checkups) from surgery will be monitored at 2 weeks, 1 month and 2 months, and 3 months. The timepoints additional to normal clinical timepoints are needed to gather potentially diagnostic valuable information about graft maturation, which in the future may lead to an early graft failure decision or trigger other clinical steps such as infection management.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

140Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Primary Objective	To determine if bone graft maturation can be imaged by ultrasound. Bone healing by ultrasound will be given a scale and will be compared to the reference standard micro-computed tomography (micro-CT) of tissue core biopsy taken at implant surgery	approximately 6 months

Secondary Outcomes

Measure	Description	Time Frame
Secondary Objective	To determine if bone graft maturation can be imaged by ultrasound, by comparing to clinical healing appearances. A score will be given to ultrasound image and clinical outcome and the correlation will be evaluated.	approximately 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients at least 18 years of age and have at least a tooth that is considered hopeless, planned for an extraction and a bone grafting procedure for subsequent dental implant surgery.

Exclusion Criteria:

Patients not willing or not able to have an extraction, bone graft and subsequent implant surgery due to health, finance, or any other reasons.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who are treatment planned for extraction of a hopeless tooth and socket augmentation with bone graft and are planned for a dental implant surgery.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oliver Kripfgans, PhD	Contact	734-647-0852		greentom@umich.edu

Overall Officials

Name	Affiliation	Role
Oliver Kripfgans, PhD	University of Michigan, Radiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ohio State University	Recruiting	Columbus	Ohio	43210	United States

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries
D016301	Alveolar Bone Loss
D057973	Dent Disease

Ancestor Terms

ID	Term
D001862	Bone Resorption
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D055093	Periodontal Atrophy

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Browse Branches

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