Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

University of Michigan40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Healing Wound

Interventions

Orascopic HDL 3.0 LoupesDEVICE

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 MicroscopeDEVICE

The microscope will be used during the surgical procedure on half of the subjects. The other half will be performed with loupes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Bone quality

Difference in bone density from the CBCT and ultrasound

Time frame: 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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