Ultrasound for Socket Healing Evaluation

Sponsor

University of Michigan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06017193

Collaborator

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

140

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Healing Wound Alveolar; Wound Alveolar Bone Loss Image Dent Disease

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ultrasonic Imaging of Bone Graft Healing in Extraction Sockets for Precise and Personalized Implant Therapy (HUM00226516)

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Jan 1, 2027

Outcome Measures

Primary Outcome Measures

Primary Objective [approximately 6 months]
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

Secondary Outcome Measures

Secondary Objective [approximately 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Michigan
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Principal Investigator: Hsun-Liang Chan, DDS, MS, University of Michigan
Principal Investigator: Oliver Kripfgans, PhD, University of Michigan, Radiology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hsun-Liang Chan, Assistant Program Director, Periodontics Graduate Program, University of Michigan

ClinicalTrials.gov Identifier:

NCT06017193

Other Study ID Numbers:

HUM00226516
1R01DE030872

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alveolar Bone Loss

Dent Disease

Wounds and Injuries

Study Results

No Results Posted as of Aug 30, 2023