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NCT06724497

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

ENROLLING BY INVITATION Phase 1, PHASE2 Last updated 9 December 2024
What this trial tests

Phase 1, PHASE2 trial testing face scanning pre and post orthognathic surgery in Mandibular Prognathism in 11 participants. Enrolling by invitation.

Timeline
24 September 2024
Primary endpoint
24 April 2025
24 September 2025

Quick facts

Lead sponsorCairo University
PhasePhase 1, PHASE2
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment11
Start date24 September 2024
Primary completion24 April 2025
Estimated completion24 September 2025
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Cairo University

Who can join

Adults 18 to 50, any sex, with Mandibular Prognathism or Orthognathic Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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