Ultrasound for Socket Healing Evaluation

NCT ID: NCT06017193

Last Updated: 2025-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-25

Study Completion Date

2027-07-01

Brief Summary

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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. The socket will be evaluated before the extraction and multi-time points during healing until an implant is placed with various evaluation tools, including ultrasound.

Detailed Description

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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.

Conditions

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Healing Wound Alveolar; Wound Alveolar Bone Loss Image Dent Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Oliver Kripfgans

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oliver Kripfgans, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan, Radiology

Locations

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Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Oliver Kripfgans, PhD

Role: CONTACT

734-647-0852

Facility Contacts

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Deborah Hooper

Role: primary

734-780-0974

Oscar Duran-Garnica, DDS, MS

Role: backup

Other Identifiers

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1R01DE030872

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00226516

Identifier Type: -

Identifier Source: org_study_id

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