Healing Wound Clinical Trial
Official title:
Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography - A Randomized Controlled Trial
Verified date | February 2024 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess healing after tooth extraction with simultaneous socket augmentation (bone grafting during the same appointment as the extraction) when the surgeon uses a surgical microscope, compared to when the surgeon uses dental loupes (magnifiers that are mounted on the surgeon's glasses). These devices magnify and shine light on the area where the surgeon operates.
Status | Completed |
Enrollment | 40 |
Est. completion date | July 21, 2023 |
Est. primary completion date | June 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. At least 18 years of age 2. Single maxillary or mandibular hopeless tooth (a maxillary or mandibular anterior tooth or premolar) planned for extraction due to periapical pathology with a minimum =2 mm of the size of the periapical radiolucency shown on a peri-apical film. 3. The patient is planned for implant restoration for the hopeless tooth 4. The study site allows for implant placement with or without additional bone augmentation procedures after the healing 5. Adequate edentulous space for the final restoration on the implant Exclusion Criteria: 1. Current smokers or quit smoking less than 6 months 2. Major or uncontrolled medical conditions, e.g. poorly controlled diabetes mellitus (HbA1c >8.0%, uncontrolled systemic disease or condition known to alter bone metabolism, e.g. osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, etc. 3. Pregnancy, breast-feeding, could be pregnant or planning to become pregnant in the next 4 months (self-reported) 4. Taking medications known to modify bone metabolism (i.e. bisphosphonates, corticosteroids, hormone replacement therapy) |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan School of Dentistry | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Delta Dental Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bone quality | Difference in bone density from the CBCT and ultrasound | 12 weeks | |
Secondary | Patient-reported outcomes | Difference in patient-reported outcomes. Subjects will be given a questionnaire to evaluate pain perception, pain medication use, and complications after surgery. | 1 week, 2 weeks, and 4 weeks |
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