Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

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

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.

Study Overview

• Status: Completed
• Conditions: Healing Wound
• Intervention / Treatment: Device: Orascopic HDL 3.0 Loupes; Device: Semorr DOM3000D Operation Microscope

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone quality	Difference in bone density from the CBCT and ultrasound	12 weeks

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Delta Dental Foundation
• Investigators: Principal Investigator: Hsun-Liang Chan, DDS, MS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2022
• Primary Completion (Actual): June 26, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HUM00195615

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No