---
title: Accuracy of Three-Dimensional Soft Tissue Prediction Using Dolphin 3D Software in Patients With Mandibular Deformities Undergoing Orthognathic Surgery
nct_id: NCT07557758
overall_status: COMPLETED
sponsor: Ain Shams University
study_type: OBSERVATIONAL
primary_condition: Orthognathic Surgical Procedures
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07557758.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07557758"
ct_last_update_post_date: 2026-04-29
last_seen_at: "2026-05-12T07:31:19.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Accuracy of Three-Dimensional Soft Tissue Prediction Using Dolphin 3D Software in Patients With Mandibular Deformities Undergoing Orthognathic Surgery

**NCT ID:** [NCT07557758](https://clinicaltrials.gov/study/NCT07557758)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 16
- **Lead Sponsor:** Ain Shams University
- **Conditions:** Orthognathic Surgical Procedures, Three Dimensional (3D) Orthodontic Device
- **Start Date:** 2020-01-01
- **Completion Date:** 2026-01-15
- **CT.gov Last Update:** 2026-04-29

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 35 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

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

## Interventions

- **Dolphin 3D Software** (DIAGNOSTIC_TEST) — Dolphin Imaging \& Management Solution, Patterson Dental

## Primary Outcomes

- **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

## Locations (1)

- Ain Shams University, Cairo, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ain shams university|cairo||egypt` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07557758*  
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