Alveolar Bone Loss Clinical Trial
Official title:
Ultrasonic Imaging of Bone Graft Healing in Extraction Sockets for Precise and Personalized Implant Therapy (HUM00226516)
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.
Status | Not yet recruiting |
Enrollment | 140 |
Est. completion date | July 1, 2027 |
Est. primary completion date | July 1, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | National Institute of Dental and Craniofacial Research (NIDCR) |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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