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Completed

NCT Number: NCT05297071

Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Bone quality

    Time frame: 12 weeks

    Difference in bone density from the CBCT and ultrasound

Secondary outcomes

  1. Patient-reported outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Delta Dental Foundation

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 25, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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