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NCT03652155 Clinical Trial

Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery

Dentofacial Deformities Clinical Trial

Official title:
Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03652155
Other study ID # 7694
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 12, 2018
Est. completion date December 31, 2021

Study information
Verified date July 2021
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to evaluate the relationship between hard and soft tissue advancement during orthognathic surgery. The use of typical pre and post operative imaging consisting of con-beam computed tomography will be used, in conjunction with a 3D camera to evaluate hard and soft tissue points before and after surgery.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 45
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patient's undergoing orthognathic surgery for correction of a dentofacial deformity Exclusion Criteria: - patients with previous orthognathic surgery patients with cranio-facial syndromes

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Orthognathic surgery
Patient's pre and post operative hard and soft tissues will be evaluated retrospectively through the use of con-beam computed tomography imaging for hard tissue evaluation and 3DMd three dimensional photography for soft tissue imaging.

Locations
Country Name City State
Canada Nova Scotia Health Authority Halifax Nova Scotia

Sponsors (1)
Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hard and soft tissue change The difference between standard pre and post operative hard and soft tissue positioning will be evaluated. Comparisons will be made between the actual bony advancement of a particular bony landmark, and compare that advancement to the advancement seen with a corresponding soft tissue landmark. pre operative and post operative imaging is taken immediately before, and 24 hours post operatively, respectively.
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