Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

Healing Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05297071
• Other study ID #: HUM00195615
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• Healing Wound

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