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

April 26, 2026 updated by: Ahmed Minshawi, Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Patients who are seeking esthetic improvement.
  2. Skeletal class II deformities.
  3. Skeletal class III deformities.

Exclusion Criteria:

  1. Syndromic patients.
  2. Degenerative joint disease on examination.
  3. Patients had a bone disease as osteoporosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
having a skeletal deformity requiring surgical intervention to correct their jaw relation
Diagnostic test: Dolphin 3D Software
Dolphin Imaging & Management Solution, Patterson Dental

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The soft tissue prediction Accuracy
Time Frame: Day 0, and after 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

December 13, 2025

Study Completion (Actual)

January 15, 2026

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

April 26, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 94-17.07.2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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