Ultrasound for Socket Healing Evaluation

NCT06017193 | Recruiting

• 2 other identifiers: HUM002265161R01DE030872
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healing Wound; Alveolar; Wound; Alveolar Bone Loss; Image; Dent Disease

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Secondary Objective

  approximately 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tissue core biopsy from healed sockets.

MeSH Terms

Conditions

Wounds and Injuries; Alveolar Bone Loss; Dent Disease

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Renal Tubular Transport, Inborn Errors; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Oliver Kripfgans, PhD

  University of Michigan, Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Kripfgans, PhD

CONTACT

734-647-0852; greentom@umich.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 30, 2023
• Study Start: July 25, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 31, 2025

Record last verified: 2025-10

Locations

US (1)