Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

Not Applicable

Completed

• Conditions: Healing Wound
• Interventions: Device: Orascopic HDL 3.0 Loupes; Device: Semorr DOM3000D Operation Microscope

• Registration Number: NCT05297071
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Study Start: 2022-03-22
• Study First Posted: 2022-03-25
• Primary Completion: 2023-06-26
• Study Completion: 2023-07-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dental Loupes	Orascopic HDL 3.0 Loupes	The surgeon will use dental loupes with a head lamp during the subject's tooth extraction and socket grafting.
Surgical microscope	Semorr DOM3000D Operation Microscope	The surgeon will use a surgical microscope (with built-in lighting) during the subject's tooth extraction and socket grafting.

Primary Outcome Measures

Name	Time	Method
Bone quality	12 weeks	Difference in bone density from the CBCT and ultrasound

Secondary Outcome Measures

Name	Time	Method
Patient-reported outcomes	1 week, 2 weeks, and 4 weeks	Difference in patient-reported outcomes. Subjects will be given a questionnaire to evaluate pain perception, pain medication use, and complications after surgery.

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States