Dentofacial DeformitiesNCT03652155
Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery
An observational study of Dentofacial Deformities, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dentofacial Deformities
- What is being tested?
- Orthognathic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 12 Dec 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Any patient undergoing orthognathic surgery for correction of a pre-existing dentofacial deformity.
Who may be able to join
- Patient's undergoing orthognathic surgery for correction of a dentofacial deformity
Who cannot join
- patients with previous orthognathic surgery patients with cranio-facial syndromes
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Orthognathic surgery
- Medical subject headings
- Dentofacial Deformities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthognathic surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Orthognathic Surgery Patients | The study cohort will be patients undergoing orthognathic surgery for correction of an existing dentofacial deformity. Receives: Procedure: Orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre operative and post operative imaging is taken immediately before, and 24 hours post operatively, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start12 Dec 2018
- Primary completion22 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentofacial DeformitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652155
- Sponsor's protocol ID
- 7694
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2018
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT03652155
- Acronym / sponsor ID
- 7694
- Conditions
- Dentofacial Deformities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orthognathic Surgery Patients | – | Procedure: Orthognathic surgeryThe study cohort will be patients undergoing orthognathic surgery for correction of an existing dentofacial deformity. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient undergoing orthognathic surgery for correction of a pre-existing dentofacial deformity.
Key inclusion criteria (1 listed)
- Patient's undergoing orthognathic surgery for correction of a dentofacial deformity
Key exclusion criteria (1 listed)
- patients with previous orthognathic surgery patients with cranio-facial syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthognathic surgeryPatient'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. | Procedure or surgery | Orthognathic Surgery Patients |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No. This data will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dentofacial Deformities, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hard and soft tissue change (time frame: pre operative and post operative imaging is taken immediately before, and 24 hours post operatively, respectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.