An interventional study of Orascopic HDL 3.0 Loupes and Semorr DOM3000D Operation Microscope in Healing Wound, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
After a tooth is extracted, a hole is left in the bone called a socket. During the first year of healing after a tooth extraction, there may be up to 60% loss of bone volume at the site. Loss of bone at the edentulous ridge (toothless area) may make it more difficult to place dental implants later. Dental socket grafting is performed to reduce bone resorption after tooth extraction. Grafting involves filling the socket with bone graft (donated human cadaver derived) and covering it with a protective collagen membrane. This graft prevents resorption of the ridge and is slowly replaced with the patient's own bone. The investigators will be trying to determine if bone healing is better if the surgeon uses more powerful magnification.
University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
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Exclusion Criteria:
The surgeon will use dental loupes with a head lamp during the subject's tooth extraction and socket grafting.
Device: Orascopic HDL 3.0 Loupes
The surgeon will use a surgical microscope (with built-in lighting) during the subject's tooth extraction and socket grafting.
Device: Semorr DOM3000D Operation Microscope
The loupes will be used during the surgical procedure on half of the subjects. The other half will be performed with a microscope.
The microscope will be used during the surgical procedure on half of the subjects. The other half will be performed with loupes.
Bone quality
Difference in bone density from the CBCT and ultrasound
Time frame: 12 weeks
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.
Time frame: 1 week, 2 weeks, and 4 weeks
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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University of Michigan