- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04353635
Prediction Accuracy of Dolphin 3D in Bimax Surgery for Class III
The Assessment of Prediction of Soft Tissue Changes Following the Surgical Correction of Dento-facial Deformities Using Dolphin 3D Software Package.
Study Overview
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nehal Shobair, master
- Phone Number: 00201063666985
- Email: nehal.shobair@gmail.com
Study Contact Backup
- Name: amr amin, phd
- Phone Number: 00201112555297
- Email: Amrghanem@asfd.asu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients with class III dentofacial deformity
No intervention as it will be a retrospective study
|
software
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The distance between the corresponding vertices
Time Frame: 6 months
|
Tthe secondary outcome measures will be the distance between the corresponding vertices which will be displayed as a colour scale in milli-meters
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 732092017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Orthognathic Surgery
-
Alexandria UniversityCompletedOrthognathic SurgeryEgypt
-
Cairo UniversityCompleted
-
University Hospital, ToulouseUnknown
-
Cairo UniversityRecruiting
-
Kaohsiung Medical University Chung-Ho Memorial...Enrolling by invitationOrthognathic SurgeryTaiwan
-
AZ Sint-Jan AVRadboud University Medical Center; IRCCS Azienda Ospedaliero-Universitaria... and other collaboratorsCompleted
-
Kaohsiung Medical University Chung-Ho Memorial...Completed
-
AZ Sint-Jan AVCompletedOrthognathic SurgeryBelgium
-
AZ Sint-Jan AVCompleted
Clinical Trials on dolphin 3d
-
Johns Hopkins UniversityUnited States Department of DefenseRecruitingTraumatic Brain Injury | Dementia Alzheimers | Military ActivityUnited States
-
Campus Neurológico SéniorJohns Hopkins UniversityCompletedParkinson DiseasePortugal
-
Manhattan Physical Medicine and Rehabilitation,...Carnegie Mellon UniversityCompletedRotator Cuff InjuriesUnited States
-
Northwestern UniversityCompletedPressure UlcerUnited States
-
Baxter Healthcare CorporationGambro Dialysatoren GmbHCompletedRenal InsufficiencyGermany
-
Baxter Healthcare CorporationGambro Dialysatoren GmbHCompleted
-
Mohamed Sayed Mohamed AbbasCompletedICU Patients Dependant on Mechanical Ventilation : Safest Mode of Performing Percutaneous Tracheostomy Among ICU Ventilated Unweanable Patients
-
Washington University School of MedicineAllerganCompletedHypomastia | Primary Breast AugmentationUnited States
-
Zhujiang HospitalUnknownLiver Diseases | Biliary Tract Diseases | Pancreatic DiseasesChina