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OpenTrials
Completed

NCT Number: NCT07557758

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

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.

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Key information

Conditions

Orthognathic Surgical Procedures Three Dimensional (3D) Orthodontic Device

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Dolphin 3D Software

Diagnostic Test

Dolphin Imaging & Management Solution, Patterson Dental

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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