NCT03657589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 5, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

August 30, 2018

Last Update Submit

August 31, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • ultrasound soft tissue thickness

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

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

Secondary Outcomes (1)

  • ultrasound alveolar bone height

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

Study Arms (1)

patients with 1 missing tooth

Patients with 1 missing anterior or premolar tooth and planned for implant surgery were recruited. Gingiva and alveolar bone were ultrasound scanned and compared to CT scans and direct measures during implant surgery.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (5)

  • Bhaskar V, Chan HL, MacEachern M, Kripfgans OD. Updates on ultrasound research in implant dentistry: a systematic review of potential clinical indications. Dentomaxillofac Radiol. 2018 Jul;47(6):20180076. doi: 10.1259/dmfr.20180076. Epub 2018 Jun 6.

    PMID: 29791198BACKGROUND
  • Chan HL, Sinjab K, Li J, Chen Z, Wang HL, Kripfgans OD. Ultrasonography for noninvasive and real-time evaluation of peri-implant tissue dimensions. J Clin Periodontol. 2018 Aug;45(8):986-995. doi: 10.1111/jcpe.12918. Epub 2018 Jun 25.

    PMID: 29757464BACKGROUND
  • Chan HL, Sinjab K, Chung MP, Chiang YC, Wang HL, Giannobile WV, Kripfgans OD. Non-invasive evaluation of facial crestal bone with ultrasonography. PLoS One. 2017 Feb 8;12(2):e0171237. doi: 10.1371/journal.pone.0171237. eCollection 2017.

    PMID: 28178323BACKGROUND
  • Chung MP, Wang IC, Chan HL, Wang HL. Evaluation of Buccal Bone Concavity in the Esthetic Zone: A Cadaver Study. Implant Dent. 2017 Oct;26(5):751-755. doi: 10.1097/ID.0000000000000661.

    PMID: 28914631BACKGROUND
  • Fu JH, Yeh CY, Chan HL, Tatarakis N, Leong DJ, Wang HL. Tissue biotype and its relation to the underlying bone morphology. J Periodontol. 2010 Apr;81(4):569-74. doi: 10.1902/jop.2009.090591.

    PMID: 20367099BACKGROUND

MeSH Terms

Conditions

Gingival RecessionAlveolar Bone Loss

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal AtrophyBone ResorptionBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 5, 2018

Study Start

February 22, 2017

Primary Completion

January 16, 2018

Study Completion

January 16, 2018

Last Updated

September 5, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations