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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07557758
Enrollment
16
Registered
2026-04-29
Start date
2020-01-01
Completion date
2026-01-15
Last updated
2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DIAGNOSTIC_TESTDolphin 3D Software

Dolphin Imaging \& Management Solution, Patterson Dental

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
The soft tissue prediction AccuracyDay 0, and after 6 monthsA 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 30, 2026