Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

NCT ID: NCT05297071

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-22
• Study Completion Date: 2023-07-21

Brief 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.

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.

Conditions

Healing Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dental Loupes

The surgeon will use dental loupes with a head lamp during the subject's tooth extraction and socket grafting.

Group Type: OTHER

Orascopic HDL 3.0 Loupes

Intervention Type: DEVICE

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

Surgical microscope

The surgeon will use a surgical microscope (with built-in lighting) during the subject's tooth extraction and socket grafting.

Group Type: OTHER

Semorr DOM3000D Operation Microscope

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Delta Dental Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Hsun-Liang Chan

Assistant Program Director, Periodontics Graduate Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hsun-Liang Chan, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00195615

Identifier Type: -

Identifier Source: org_study_id