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Completed

NCT Number: NCT03657589

Sonographic Imaging of Oral and Dental Anatomical Structures (A Pilot Study)

The overall purpose of this study is to establish an ultrasound technique to aid in oral and dental examination of soft and hard tissues. Ultrasound is currently not used in Dentistry and associated oral examinations and its usefulness for clinical practice will be explored. This study will investigate the use of ultrasonic imaging for planning and placing dental implants, as well as evaluate the use of ultrasonic imaging for monitoring marginal bone loss around dental implants.

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Key information

Conditions

Ultrasound Alveolar Bone Loss Bone Diseases Bone Resorption Gingival Diseases Gingival Recession Mouth Diseases Musculoskeletal Diseases Oral Mucosa Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

This study will involve two different groups of subjects: Patients scheduled for a dental implant procedure, and patients scheduled for a revision surgery after developing infection after implant surgery.

Twenty subjects examining only specific aim one is funded and will be studied. If future funding is granted and additional 30 subjects for aim one and 40 for aim two will be studied Subjects in both groups will receive an ultrasound examination of the oral cavity prior to their clinically-scheduled dental surgery. Subjects in group 1 also may receive a CBCT scan if not previously clinically-ordered.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects 18 years of age and older who will be scheduled to have an implant surgery from premolar to premolar with bilateral adjacent teeth present will be recruited.

Exclusion criteria

  • Patients under 18 years of age.
  • Unwilling or unable to read and sign this informed consent document.
  • Do not have a tooth on each side of the implant that will be placed.
  • Women who are pregnant or unsure of their pregnancy status.

Treatment and study plan

Primary outcomes

  1. ultrasound soft tissue thickness

    Time frame: At least 6 months after implant crown placement (1 time point)

    soft tissue thickness at the missing tooth gap and adjacent teeth were measured with ultrasound

Secondary outcomes

  1. ultrasound alveolar bone height

    Time frame: At least 6 months after implant crown placement (1 time point)

    alveolar bone height at the missing tooth gap and adjacent teeth was measured

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • AAP's SUNSTAR Innovation Grant
  • Delta Dental Foundation
  • MICHR Pilot grant (UL1TR000433)
  • POM Supplemental Grant
  • SOD Collision Award

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2018
Registry last updated
Sep 5, 2018

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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