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

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03657589
• Collaborator: MICHR Pilot grant (UL1TR000433) (Other), Delta Dental Foundation (Other), POM Supplemental Grant (Other), SOD Collision Award (Other), AAP's SUNSTAR Innovation Grant (Other)
• Enrollment: 20
• Location: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ultrasound; Oral Mucosa; Gingival Recession; Alveolar Bone Loss

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 Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Sonographic Imaging of Oral and Dental Anatomical Structures (A Pilot Study)
• Actual Study Start Date: Feb 22, 2017
• Actual Primary Completion Date: Jan 16, 2018
• Actual Study Completion Date: Jan 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan School of Dentistry	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Hsun-Liang Chan, Clinical Assistant Professor, University of Michigan
• ClinicalTrials.gov Identifier: NCT03657589
• Other Study ID Numbers: HUM00099062
• First Posted: Sep 5, 2018
• Last Update Posted: Sep 5, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alveolar Bone Loss; Gingival Recession

Study Results

No Results Posted as of Sep 5, 2018