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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05297071
Other study ID # HUM00195615
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2022
Est. completion date July 21, 2023

Study information

Verified date February 2024
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Orascopic HDL 3.0 Loupes
The loupes will be used during the surgical procedure on half of the subjects. The other half will be performed with a microscope.
Semorr DOM3000D Operation Microscope
The microscope will be used during the surgical procedure on half of the subjects. The other half will be performed with loupes.

Locations

Country Name City State
United States University of Michigan School of Dentistry Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Delta Dental Foundation

Country where clinical trial is conducted

United States, 

Outcome

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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