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

Gingival Recession Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03657589
• Other study ID #: HUM00099062
• Status: Completed
• Start date: February 22, 2017
• Est. completion date: January 16, 2018

Study information

• Verified date: August 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 16, 2018
• Est. primary completion date: January 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Gingival Recession
• Oral Mucosa
• Ultrasound

Locations

Country	Name	City	State
United States	University of Michigan School of Dentistry	Ann Arbor	Michigan

Sponsors (6)

Lead Sponsor	Collaborator
University of Michigan	AAP Sunstar Award, Delta Dental Foundation, MICHR Pilot grant (UL1TR000433), POM Supplemental Grant, SOD Collision Award

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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 May 14. doi: 10.1111/jcpe.12918. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ultrasound alveolar bone height	alveolar bone height at the missing tooth gap and adjacent teeth was measured	At least 6 months after implant crown placement (1 time point)