Prediction Accuracy of Dolphin 3D in Bimax Surgery for Class III

NCT04353635 | Unknown

• 1 other identifier: 732092017
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• The distance between the corresponding vertices

  6 months

Study Arms (1)

Patients with class III dentofacial deformity

No intervention as it will be a retrospective study

Device: dolphin 3d

Interventions

dolphin 3d DEVICE

software

Patients with class III dentofacial deformity

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with classIII dentofacial deformity

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead
• University of Glasgow: collaborator

Central Study Contacts

Nehal Shobair, master

CONTACT

00201063666985; nehal.shobair@gmail.com

amr amin, phd

CONTACT

00201112555297; Amrghanem@asfd.asu.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Key Investigator

Study Record Dates

• First Submitted: March 29, 2020
• First Posted: April 20, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 20, 2020

Record last verified: 2020-04