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

Completed

• Conditions: Ultrasound; Gingival Recession; Alveolar Bone Loss; Oral Mucosa

• Registration Number: NCT03657589
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2017-02-22
• Primary Completion: 2018-01-16
• Study Completion: 2018-01-16
• Status Verified: 2018-08
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-31
• Last Update Submitted: 2018-08-31
• Study First Posted: 2018-09-05
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ultrasound soft tissue thickness	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 Outcome Measures

Name	Time	Method
ultrasound alveolar bone height	At least 6 months after implant crown placement (1 time point)	alveolar bone height at the missing tooth gap and adjacent teeth was measured

Trial Locations

Locations (1)

University of Michigan School of Dentistry; 🇺🇸 Ann Arbor, Michigan, United States