3D Photogrammetry Versus Commercial Scanners for Accurate Repositioning of the Maxilla for Correction of the Dentofacial Deformity.

NCT05755022 | Unknown

• 1 other identifier: CU-2022-12-10
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Current advances in the three-dimensional virtual surgical planning (3D-VSP) of the orthognathic surgery have brought newer insights, enormous benefits and have become an indispensable aid for diagnosis, treatment planning and outcome assessment especially in the management of dentofacial deformities. The extent to which the planned surgical outcome could be achieved is dependent on the surgeon's ability to accurately transfer the planned movements to the real surgical field. Accurate repositioning of the maxilla after Le-fort I osteotomy is of utmost importance for an esthetic and functional purposes. The goal of this interventional study is to compare the 3D photogrammetry technique versus the commercial scanners for accurate repositioning of maxillary segment after le-fort I osteotomy using the reverse engineering technology. The main question it aims to answer; Is the utilization of the 3D Photogrammetry technique affect the accuracy of maxillary segment repositioning after le-fort I osteotomy compared with the commercial scanners?

Conditions

Dentofacial Deformities

Keywords

3D Photogrammetry; Reverse Engineering; Orthognathic Surgery; Pre-bent Plates

Outcome Measures

Primary Outcomes (1)

• Accuracy of maxillary segment repositioning

  The actual postoperative 3D maxillary segment position will be compared with the preoperative virtual maxillary positioning by: A) Linear and angular measurements: Some specific reproducible points and planes will be identified on the 3D virtual model, and then on the post-surgery model. The distance from points to planes will be calculated on each model and the difference between these distances is to be registered as the error of accuracy. B) Color-coded map: Different colors show the distance between the surfaces, with green color usually showing the lack of distance, meaning zero error of accuracy. This method of assessing changes in 3D surfaces involves measuring the point-to-point distance of one mesh (VSP - 3D model reference) to the second mesh (Postoperative - 3D model test) and generating a color distance map.

  Outcome will be assessed with immediate postoperative Computed Tomography at one week.

Study Arms (2)

Maxillary segment repositioning by utilizing reverse engineering using the 3D photogrammetry.

EXPERIMENTAL

* The printed stereolithographic model with the adapted miniplates will be scanned using 3D photogrammetry technique and a specific software dedicated for image acquisition will be used. * A guide will be designed on the reproduced virtual model. This guide will be used intraoperative as a locating and positioning guide for the maxilla and the plates.

Procedure: Maxillary Segment Repositioning

Maxillary segment repositioning by utilizing reverse engineering using the commercial scanners.

ACTIVE COMPARATOR

• The printed stereolithographic model with the adapted miniplates will be scanned using the commercial scanners and imported for virtual designing of the positioning and locating guide that will be used intraoperative for positioning the maxilla.

Procedure: Maxillary Segment Repositioning

Interventions

Maxillary Segment Repositioning PROCEDURE

* Le-Fort I osteotomy will be made using the cutting guide. * Mobilization of the maxilla will be done. * The osteotomized segment will be positioned using the positioning guide that will be fabricated utilizing the reverse engineering technology using 3D photogrammetry technique. * While the guide in place, the plates will be fixed into their intended position. * After fixation of the plates, the guide will be removed.

Maxillary segment repositioning by utilizing reverse engineering using the 3D photogrammetry.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age range of 18-60 years.
• Patients requiring one-piece Le-Fort I osteotomy as part of their orthognathic surgery for the correction of dentofacial deformity.
• Patients should be free from any significant medical condition that could affect or hinder normal healing and predictable outcomes.
• Patients with no signs or symptoms of temporomandibular joint disorders.
• Patients who will be committed to the follow up period and agree to sign the informed consent.

You may not qualify if:

• Patients requiring segmental Le-Fort I osteotomy.
• Patients with previous history of orthognathic surgery.
• Patients with cleft lip and palate.
• Patients with skeletal deformities owing to trauma or tumor resection.
• Patients with any intra-bony lesions or infections.
• Patients with temporomandibular joint disorders.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Giza, 11553, Egypt

RECRUITING

Related Publications (8)

• Ong TK, Banks RJ, Hildreth AJ. Surgical accuracy in Le Fort I maxillary osteotomies. Br J Oral Maxillofac Surg. 2001 Apr;39(2):96-102. doi: 10.1054/bjom.2000.0577.

  PMID: 11286442 BACKGROUND

• Mazzoni S, Bianchi A, Schiariti G, Badiali G, Marchetti C. Computer-aided design and computer-aided manufacturing cutting guides and customized titanium plates are useful in upper maxilla waferless repositioning. J Oral Maxillofac Surg. 2015 Apr;73(4):701-7. doi: 10.1016/j.joms.2014.10.028. Epub 2014 Nov 29.

  PMID: 25622881 BACKGROUND

• Pascal E, Majoufre C, Bondaz M, Courtemanche A, Berger M, Bouletreau P. Current status of surgical planning and transfer methods in orthognathic surgery. J Stomatol Oral Maxillofac Surg. 2018 Jun;119(3):245-248. doi: 10.1016/j.jormas.2018.02.001. Epub 2018 Feb 22.

  PMID: 29476926 BACKGROUND

• Pietzka S, Mascha F, Winter K, Kammerer PW, Sakkas A, Schramm A, Wilde F. Clinical Accuracy of 3D-Planned Maxillary Positioning Using CAD/CAM-Generated Splints in Combination With Temporary Mandibular Fixation in Bimaxillary Orthognathic Surgery. Craniomaxillofac Trauma Reconstr. 2020 Dec;13(4):290-299. doi: 10.1177/1943387520949348. Epub 2020 Aug 17.

  PMID: 33456700 BACKGROUND

• Kraeima J, Schepers RH, Spijkervet FKL, Maal TJJ, Baan F, Witjes MJH, Jansma J. Splintless surgery using patient-specific osteosynthesis in Le Fort I osteotomies: a randomized controlled multi-centre trial. Int J Oral Maxillofac Surg. 2020 Apr;49(4):454-460. doi: 10.1016/j.ijom.2019.08.005. Epub 2019 Sep 8.

  PMID: 31506186 BACKGROUND

• Heufelder M, Wilde F, Pietzka S, Mascha F, Winter K, Schramm A, Rana M. Clinical accuracy of waferless maxillary positioning using customized surgical guides and patient specific osteosynthesis in bimaxillary orthognathic surgery. J Craniomaxillofac Surg. 2017 Sep;45(9):1578-1585. doi: 10.1016/j.jcms.2017.06.027. Epub 2017 Jul 8.

  PMID: 28793965 BACKGROUND

• Hernandez-Alfaro F, Guijarro-Martinez R. New protocol for three-dimensional surgical planning and CAD/CAM splint generation in orthognathic surgery: an in vitro and in vivo study. Int J Oral Maxillofac Surg. 2013 Dec;42(12):1547-56. doi: 10.1016/j.ijom.2013.03.025. Epub 2013 Jun 13.

  PMID: 23768749 BACKGROUND

• Jabar N, Robinson W, Goto TK, Khambay BS. The validity of using surface meshes for evaluation of three-dimensional maxillary and mandibular surgical changes. Int J Oral Maxillofac Surg. 2015 Jul;44(7):914-20. doi: 10.1016/j.ijom.2015.02.005. Epub 2015 Mar 6.

  PMID: 25752242 BACKGROUND

Related Links

• Surgical accuracy in Le Fort I maxillary osteotomies
• Computer-aided design and computer-aided manufacturing cutting guides and customized titanium plates are useful in upper maxilla waferless repositioning
• Current status of surgical planning and transfer methods in orthognathic surgery
• Clinical Accuracy of 3D-Planned Maxillary Positioning Using CAD/CAM-Generated Splints in Combination With Temporary Mandibular Fixation in Bimaxillary Orthognathic Surgery
• Splintless surgery using patient-specific osteosynthesis in Le Fort I osteotomies: a randomized controlled multi-centre trial
• Clinical accuracy of waferless maxillary positioning using customized surgical guides and patient specific osteosynthesis in bimaxillary orthognathic surgery
• New protocol for three-dimensional surgical planning and CAD/CAM splint generation in orthognathic surgery: an in vitro and in vivo study
• The validity of using surface meshes for evaluation of three-dimensional maxillary and mandibular surgical changes

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mohamed G Beheiri, PhD

  Professor

  STUDY DIRECTOR

• Samer Noman, PhD

  Assistant Professor

  STUDY DIRECTOR

• Sherif A Hassan, PhD

  Assistant Professor

  STUDY DIRECTOR

• Dina Y Girgis, Master

  Assistant lecturer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina Y Girgis, Master

CONTACT

01278061226; dina.yacoub@dentistry.cu.edu.eg

Samer Noman, PhD

CONTACT

01111366619; samer.noman@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: January 9, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 6, 2023

Record last verified: 2023-02

Locations

EG (1)