Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography - A Randomized Controlled Trial

Conditions
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Healing Wound

Intervention / Treatment
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* Device: Orascopic HDL 3.0 Loupes
* Device: Semorr DOM3000D Operation Microscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years of age 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. The patient is planned for implant restoration for the hopeless tooth The study site allows for implant placement with or without additional bone augmentation procedures after the healing Adequate edentulous space for the final restoration on the implant Exclusion Criteria: Current smokers or quit smoking less than 6 months 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. Pregnancy, breast-feeding, could be pregnant or planning to become pregnant in the next 4 months (self-reported) Taking medications known to modify bone metabolism (i.e. bisphosphonates, corticosteroids, hormone replacement therapy)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dental Loupes<br>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<br>* The loupes will be used during the surgical procedure on half of the subjects. The other half will be performed with a microscope.<br>|
| Other: Surgical microscope<br>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<br>* The microscope will be used during the surgical procedure on half of the subjects. The other half will be performed with loupes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone density | Difference in bone density from the micro-CT | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |