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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652155
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Nick Emanuele, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment
Dentofacial Deformities Procedure: Orthognathic surgery

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Group/Cohort Intervention/treatment
Orthognathic Surgery Patients
The study cohort will be patients undergoing orthognathic surgery for correction of an existing dentofacial deformity.
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.




Primary Outcome Measures :
  1. Hard and soft tissue change [ Time Frame: pre operative and post operative imaging is taken immediately before, and 24 hours post operatively, respectively. ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Any patient undergoing orthognathic surgery for correction of a pre-existing dentofacial deformity.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652155


Contacts
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Contact: Nicholas F Emanuele, DDS 902-292-5511 nemanuele@dal.ca
Contact: Curtis Gregoire, DDS/MD/MSc 902-473-2070 cgregoir@dal.ca

Locations
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Canada, Nova Scotia
Nova Scotia Health Authority Recruiting
Halifax, Nova Scotia, Canada, B4A 3W5
Contact: Ken Jenkins    902-473-8426    ken.jenkins@nshealth.ca   
Sponsors and Collaborators
Nova Scotia Health Authority

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Responsible Party: Nick Emanuele, Resident, Department of Oral and Maxillofacial Surgery, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03652155    
Other Study ID Numbers: 7694
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This data will not be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dentofacial Deformities
Congenital Abnormalities
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Stomatognathic System Abnormalities
Stomatognathic Diseases