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

NCT ID: NCT03657589

Last Updated: 2018-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-22

Study Completion Date

2018-01-16

Brief Summary

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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

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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.

Conditions

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Ultrasound Oral Mucosa Gingival Recession Alveolar Bone Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MICHR Pilot grant (UL1TR000433)

UNKNOWN

Sponsor Role collaborator

Delta Dental Foundation

OTHER

Sponsor Role collaborator

POM Supplemental Grant

UNKNOWN

Sponsor Role collaborator

SOD Collision Award

UNKNOWN

Sponsor Role collaborator

AAP's SUNSTAR Innovation Grant

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Hsun-Liang Chan

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 29791198 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29757464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28178323 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28914631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20367099 (View on PubMed)

Other Identifiers

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HUM00099062

Identifier Type: -

Identifier Source: org_study_id

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