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

NCT03652155 | Completed

• 1 other identifier: 7694
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dentofacial Deformities

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Orthognathic Surgery Patients

The study cohort will be patients undergoing orthognathic surgery for correction of an existing dentofacial deformity.

Procedure: Orthognathic surgery

Interventions

Orthognathic surgery PROCEDURE

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.

Orthognathic Surgery Patients

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient undergoing orthognathic surgery for correction of a pre-existing dentofacial deformity.

You may qualify if:

• Patient's undergoing orthognathic surgery for correction of a dentofacial deformity

You may not qualify if:

• patients with previous orthognathic surgery patients with cranio-facial syndromes

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B4A 3W5, Canada

Location

MeSH Terms

Conditions

Dentofacial Deformities

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: December 12, 2018
• Primary Completion: October 22, 2021
• Study Completion: December 31, 2021
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)