Accuracy of Three-Dimensional Soft Tissue Prediction Using Dolphin 3D Software in Patients With Mandibular Deformities Undergoing Orthognathic Surgery

NCT07557758 | Completed DMC

• 1 other identifier: 94-17.07.2019
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the accuracy of "Dolphin 3D" software for prediction of soft tissue changes in management of patients seeking orthognathic surgery to treat their mandibular deformities and collecting their feedback regarding aesthetic satisfaction.

Conditions

Orthognathic Surgical Procedures; Three Dimensional (3D) Orthodontic Device

Outcome Measures

Primary Outcomes (1)

• The soft tissue prediction Accuracy

  A comparison between the virtually planned mandibular movement and postoperative 3D photo All patients had to have both preoperative (Tpre) and at least 6 m postoperative (Tpost) CBCTs . All CBCT images were acquired with a Scanner as a part of the initial diagnostic records . Tpre and Tpost CBCT scans were imported to Dolphin 3D software. Three-dimensional voxel-based superimposition on the cranial base was performed between Tpre and Tpost for each patient, to accurately measure the skeletal movements performed during the surgery. A virtual orthognathic surgery (Tsim) was performed on T0 image to mimic the actual skeletal movements using the virtual surgical planning tool in Dolphin 3D .The differences between TSim and T1for the patients were measured

  Day 0, and after 6 months

Study Arms (1)

having a skeletal deformity requiring surgical intervention to correct their jaw relation

Diagnostic Test: Dolphin 3D Software

Interventions

Dolphin 3D Software DIAGNOSTIC_TEST

Dolphin Imaging \& Management Solution, Patterson Dental

having a skeletal deformity requiring surgical intervention to correct their jaw relation

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients having a skeletal deformity requiring surgical intervention to correct their jaw relation

You may qualify if:

• Patients who are seeking esthetic improvement.
• Skeletal class II deformities.
• Skeletal class III deformities.

You may not qualify if:

• Syndromic patients.
• Degenerative joint disease on examination.
• Patients had a bone disease as osteoporosis.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctorate Candidate at Ain shams University

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: April 29, 2026
• Study Start: January 1, 2020
• Primary Completion: December 13, 2025
• Study Completion: January 15, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

EG (1)