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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06017193
Other study ID # HUM00226516
Secondary ID 1R01DE030872
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date July 1, 2027

Study information

Verified date April 2024
Source University of Michigan
Contact Oliver Kripfgans, PhD
Phone 734-647-0852
Email greentom@umich.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
n/a

Sponsors (2)

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

Outcome

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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