Evaluating the Accuracy of Soft Tissue Prediction in Patients With Mandibular Prognathism After Orthognathic Surgery Using Handheld Scanner Versus Optical Scanner A Prospective Clinical Trial

NCT06724497 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: 337
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of study: To evaluate the accuracy of soft tissue prediction in orthognathic surgery using handheld scanners versus optical scanners. Research hypothesis (null hypothesis): there is no difference in prediction accuracy between laser scans and handheld scans. Primary objective: To evaluate The Accuracy of soft tissue prediction in orthognathic surgery using handheld scanner versus laser scanner . Secondary objective: To evaluate scanning time, cost efficiency, and ease of use. patients will be treated from mandibular prognathism using only mandibular set back or bimaxillary surgery After six months postoperatively, 3D facial scans is obtained and exported to software to perform superimposition of the predicted and post operative results to assess the accuracy of soft tissue prediction By measuring the difference in millimeter between prespecified points

Conditions

Mandibular Prognathism; Orthognathic Surgery

Keywords

Prognathism; soft tissue prediction; face scanner; handheld scanner; optical scanner; orthognathic surgery; prediction accuracy

Outcome Measures

Primary Outcomes (1)

• soft tissue prediction accurace

  3d facial scans is obtained and exported to software to perform superimposition of the predicted and post operative results to assess the accuracy of soft tissue prediction By measuring the difference in millimeter between prespecified points 1-full face 2-subnasal 3-labrale superioris 4- labrale inferioris 5-pogonion 6- corners of the mouth Then the degree of accuracy will be measured in percentage

  six months after surgery

Study Arms (1)

patient with mandibular prognathism

OTHER

same patient will be scanned twice using both devices the optical face scanner and the handheld optical scanner

Procedure: face scanning pre and post orthognathic surgery

Interventions

face scanning pre and post orthognathic surgery PROCEDURE

patient will be scanned pre operative using both scanners and then undergo orthognathic surgery then will be rescanned again 6 montsh later

patient with mandibular prognathism

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with facial mandibular prognathism that requires orthognathic surgery.
• Age (18- 50 years).
• Patients are willing for the surgical procedure and follow-up, with informed consent

You may not qualify if:

• Dental malocclusion that could be treated with orthodontic treatment only.
• Patients with contraindications for general anesthesia.
• Patient on radiotherapy.
• Patients suffer from bone disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, Giza Governorate, 35855, Egypt

Location

MeSH Terms

Conditions

Malocclusion, Angle Class III; Prognathism

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Mandibular Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mohamed Ahmed Farid, Professor of OMFS

  Cairo University

  STUDY DIRECTOR

• Sameh Tarek Mekhemar, Head of Department

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 9, 2024
• Study Start: September 24, 2024
• Primary Completion: April 24, 2025
• Study Completion: September 24, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

EG (1)