Clinical trial NCT05297071: Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography
Official title: Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healing Wound
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Delta Dental Foundation
First posted: 2022-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Bone quality
timeFrame: 12 weeks
Secondary outcomes:
measure: Patient-reported outcomes
timeFrame: 1 week, 2 weeks, and 4 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Hsun-Liang Chan, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: