Ultrasound for Socket Healing Evaluation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Healing Wound, Alveolar; Wound, Alveolar Bone Loss, Image. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Ultrasonic Imaging of Bone Graft Healing in Extraction Sockets for Precise and Personalized Implant Therapy (HUM00226516)
Overview
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.
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.
Primary outcome measures
- Primary Objective [Time frame: approximately 6 months]
Secondary outcome measures (1)
- Secondary Objective [Time frame: approximately 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ohio State University — Columbus
Identifiers
NCT: NCT06017193 · HUM00226516 · 1R01DE030872