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Recruiting

NCT Number: NCT06017193

Ultrasound for Socket Healing Evaluation

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.

Recruiting

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Primary Objective

    Time frame: 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 outcomes

  1. Secondary Objective

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oliver Kripfgans, PhD

CONTACT

[email protected]

734-647-0852

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2023
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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