Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

NCT05297071 | Completed

• 1 other identifier: HUM00195615
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Wound

Outcome Measures

Primary Outcomes (1)

• Bone quality

  Difference in bone density from the CBCT and ultrasound

  12 weeks

Secondary Outcomes (1)

• Patient-reported outcomes

  1 week, 2 weeks, and 4 weeks

Study Arms (2)

Dental Loupes

OTHER

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

Surgical microscope

OTHER

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

Interventions

Orascopic HDL 3.0 Loupes DEVICE

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

Dental Loupes

Semorr DOM3000D Operation Microscope DEVICE

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

Surgical microscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• 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.
• The patient is planned for implant restoration for the hopeless tooth
• The study site allows for implant placement with or without additional bone augmentation procedures after the healing
• Adequate edentulous space for the final restoration on the implant

You may not qualify if:

• Current smokers or quit smoking less than 6 months
• 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.
• Pregnancy, breast-feeding, could be pregnant or planning to become pregnant in the next 4 months (self-reported)
• Taking medications known to modify bone metabolism (i.e. bisphosphonates, corticosteroids, hormone replacement therapy)

Sponsors & Collaborators

• University of Michigan: lead
• Delta Dental Foundation: collaborator

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

• Hsun-Liang Chan, DDS, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Program Director, Periodontics Graduate Program

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 25, 2022
• Study Start: March 22, 2022
• Primary Completion: June 26, 2023
• Study Completion: July 21, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)