Orthognathic SurgeryNCT04353635
Prediction Accuracy of Dolphin 3D in Bimax Surgery for Class III
An observational study of Orthognathic Surgery, run by Ain Shams University.
Trial summary
Patients with class III dentofacial deformity who are in need of surgical correction are now able to see the potential changes to their faces before the actual operation. Dolphin 3d is one of the few software packages that is used for orthognathic planning and prediction of soft tissue changes. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- dolphin 3d
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Oct 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with classIII dentofacial deformity
Who may be able to join
- Patients who have class III facial deformity to be corrected using bimaxillary orthognathic surgery.
- No medical problems that might interfere with general anesthesia or interfere with bone and soft tissue healing.
Who cannot join
- There are craniofacial anomalies including cleft lip/palate,
- Patient have previous maxillofacial operations or facial scars,
- Correction mandates multi-segment Le Fort I osteotomies,
- There are orthodontic appliances in place at the time of T1 records.
- Genioplasty is recommended for deformity correction.
- There is facial Asymmetry.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Assessment of Prediction of Soft Tissue Changes Following the Surgical Correction of Dento-facial Deformities Using Dolphin 3D Software Package.
Patients with class III dentofacial deformity who are in need of surgical correction are now able to see the potential changes to their faces before the actual operation. Dolphin 3d is one of the few software packages that is used for orthognathic planning and prediction of soft tissue changes. The direct effect of the prediction procedure over patient's and surgeon decisions makes it important to guarantee a high level of accuracy of operational results prediction. This study is designed to investigate the accuracy of Dolphin 3d software for the prediction of postoperative soft tissue changes following specific surgical procedure which is the combined maxillary advancement and mandibular setback, commonly used for correction of class III facial deformity cases. The study data will be collecting retrospectively. The difference between the pre-operative soft tissue prediction and the 6-month postoperative results will be analysed. The results of this study will help to determine whether this software package is accurate enough to be considered as a surgical assistance tool helping both surgeons and patients in treatment planning and decision-making procedure respectively.
Read the detailed description
The study will employ the pre-existing CBCT images routinely captured for orthognathic surgery patients in Glasgow dental hospital and school.
The CBCT scans of class III patients who undergone maxillary advancement with minimal or without impaction and mandibular setback will be identified.
The preoperative and 6 months postoperative CBCT images will be anonymised The surgical planning and soft tissue prediction will be performed on the preoperative images using Dolphin3d software.
The resultant soft tissue 3D model will be superimposed on the actual postoperative soft tissue model.
Analysis of the difference between the prediction and the actual postoperative will be performed to quantify the difference between them in order to assess the accuracy of the software prediction.
The sample will be collected according to the inclusion and exclusion criteria. Pre and post operation CBCT voxel based super imposition using ONDEMAND 3d. The surgical movement will be quantified using direct slice land-marking . Using the pre-operattion CBCT to do the surgical mock up and the soft tissue simulation on dolphin 3D.
Segment the soft tissue of the prediction. Soft tissue surface models of the simulation and the actual postoperative images were generated and exported as STLs.
Generic meshes conformation dense correspondence analysis. Superimposition of the predicted and the post operative STLs. Using VR mesh software, the mesh will be segmented into pre-identified anatomical regions.
The distance between the corresponding vertices will be displayed as a colour scale in milli-meter and will be analysed in the individual dimension of space (x, y and z) using in-house software and each dimension will be displayed as a colour coded distance map.
- Conditions
- Orthognathic Surgery
- Being tested
- dolphin 3d
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dolphin 3dDevice
software
| Study group | Role | What they receive |
|---|---|---|
| Patients with class III dentofacial deformity | No intervention as it will be a retrospective study Receives: Device: dolphin 3d |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between prediction and actual postoperative
The difference between prediction and actual postoperative. The distance between the corresponding vertices will be displayed as a colour scale in milli-meter and will be analysed in the individual dimension of space (x, y and z) using in-house software and each dimension will be displayed as a colour coded distance map.
Measured: 6 months
Secondary outcomes (1)
The distance between the corresponding vertices
Tthe secondary outcome measures will be the distance between the corresponding vertices which will be displayed as a colour scale in milli-meters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Nehal Ibrahim Ahmed Shobair, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353635
- Sponsor's protocol ID
- 732092017
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Assessment of Prediction of Soft Tissue Changes Following the Surgical Correction of Dento-facial Deformities Using Dolphin 3D Software Package.
- ClinicalTrials.gov ID
- NCT04353635
- Acronym / sponsor ID
- 732092017
- Conditions
- Orthognathic Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Oct 2020 (estimated)
- First posted
- 20 Apr 2020 (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.
Patients with class III dentofacial deformity who are in need of surgical correction are now able to see the potential changes to their faces before the actual operation. Dolphin 3d is one of the few software packages that is used for orthognathic planning and prediction of soft tissue changes. The direct effect of the prediction procedure over patient's and surgeon decisions makes it important to guarantee a high level of accuracy of operational results prediction. This study is designed to investigate the accuracy of Dolphin 3d software for the prediction of postoperative soft tissue changes following specific surgical procedure which is the combined maxillary advancement and mandibular setback, commonly used for correction of class III facial deformity cases. The study data will be collecting retrospectively. The difference between the pre-operative soft tissue prediction and the 6-month postoperative results will be analysed. The results of this study will help to determine whether this software package is accurate enough to be considered as a surgical assistance tool helping both surgeons and patients in treatment planning and decision-making procedure respectively.
Detailed description
The study will employ the pre-existing CBCT images routinely captured for orthognathic surgery patients in Glasgow dental hospital and school.
The CBCT scans of class III patients who undergone maxillary advancement with minimal or without impaction and mandibular setback will be identified.
The preoperative and 6 months postoperative CBCT images will be anonymised The surgical planning and soft tissue prediction will be performed on the preoperative images using Dolphin3d software.
The resultant soft tissue 3D model will be superimposed on the actual postoperative soft tissue model.
Analysis of the difference between the prediction and the actual postoperative will be performed to quantify the difference between them in order to assess the accuracy of the software prediction.
The sample will be collected according to the inclusion and exclusion criteria. Pre and post operation CBCT voxel based super imposition using ONDEMAND 3d. The surgical movement will be quantified using direct slice land-marking . Using the pre-operattion CBCT to do the surgical mock up and the soft tissue simulation on dolphin 3D.
Segment the soft tissue of the prediction. Soft tissue surface models of the simulation and the actual postoperative images were generated and exported as STLs.
Generic meshes conformation dense correspondence analysis. Superimposition of the predicted and the post operative STLs. Using VR mesh software, the mesh will be segmented into pre-identified anatomical regions.
The distance between the corresponding vertices will be displayed as a colour scale in milli-meter and will be analysed in the individual dimension of space (x, y and z) using in-house software and each dimension will be displayed as a colour coded distance map.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with class III dentofacial deformity | – | Device: dolphin 3dNo intervention as it will be a retrospective study |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with classIII dentofacial deformity
Key inclusion criteria (2 listed)
- Patients who have class III facial deformity to be corrected using bimaxillary orthognathic surgery.
- No medical problems that might interfere with general anesthesia or interfere with bone and soft tissue healing.
Key exclusion criteria (6 listed)
- There are craniofacial anomalies including cleft lip/palate,
- Patient have previous maxillofacial operations or facial scars,
- Correction mandates multi-segment Le Fort I osteotomies,
- There are orthodontic appliances in place at the time of T1 records.
- Genioplasty is recommended for deformity correction.
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 |
|---|---|---|
| dolphin 3dsoftware | Device | Patients with class III dentofacial deformity |
Primary outcome
The difference between prediction and actual postoperative
Time frame: 6 months
The difference between prediction and actual postoperative. The distance between the corresponding vertices will be displayed as a colour scale in milli-meter and will be analysed in the individual dimension of space (x, y and z) using in-house software and each dimension will be displayed as a colour coded distance map.
1 secondary outcome
The distance between the corresponding vertices
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery, run by Ain Shams University.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nehal Shobair, master (00201063666985, nehal.shobair@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between prediction and actual postoperative (time frame: 6 months). 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 20 Apr 2020.