Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony

Dentofacial Deformities Clinical Trial

Official title:

Skeletal Stability of Le Fort I Osteotomy Using Patient-specific Osteosynthesis Compared to Mini-plate Fixation for Patients With Dentofacial Disharmony. A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05340036
• Other study ID #: OMFS 3 3 7
• Status: Recruiting
• Phase: N/A
• Start date: May 26, 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Cairo University
• Contact: Hassan Alnimr
• Phone: +201002961175
• Email: hassan-fahmy[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate the Skeletal stability of Le Fort I osteotomy using patient-specific osteosynthesis compared to Mini-plate fixation for patients with skeletal class III malocclusion.

Description:

postsurgical relapse is one of the most common observations that have been reported after fixation of Le Fort I osteotomy cases.

Fixation systems with plates and screws are used in oral maxillofacial surgery for the treatment of facial fractures and orthognathic surgery cases. Although they have been used for decades and have become the standard treatment, the materials used in these systems may fail due to excess loading and other causal factors during the surgical procedure, including failure in plate adaptation and fixation to bone, material design, fabrication, and degree of purity of the plate material.

In the fixation system, non-customized plates of standard size are used, and are bent to adapt them to the distances required for planning orthognathic surgeries. Therefore, mandatory use of larger plates than those programmed for use in surgeries is required so that they can be bent to enable insertion. Moreover, there are variations in the number of screws required to retain the plates to enable better fixation. The folds of non-customized plates generate stresses that are minimized when using customized plates, because these plates are fabricated individually, with predetermined sizes for each patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Patients with skeletal class III malocclusion planned for traditional Orthognathic Approach and requiring bimaxillary orthognathic surgeries in which there will be Le Fort I osteotomy with maxillary advancement ranging from 2mm to 5 mm in addition to mandibular setback.

2. Patients with no signs or symptoms of active TMDs.

3. Highly motivated patients.

Exclusion Criteria:

1. Patients who refused to be included in the research.

2. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.

3. Patients with intra-bony lesions or infections that may retard the osteotomy healing.

Related Conditions & MeSH terms

• Dentofacial Deformities

Intervention

Procedure:
• Bimaxillary orthognathic surgery using conventional plates
le fort I osteotomy will carried out in the classic way guided by the classic landmarks (maxillary roots apices) as described by Wassmund. Complete separation of the maxillary segment using chisels and mallets in regular fashion. Reposition maxilla using the interocclusal wafer while mandible is gently positioned to centric relation position. Mandible is maintained in place until fixation of the maxilla with plates and screws takes place. Complete separation of the mandibular segment using chisels and mallets in regular fashion. Repositioning of mandible using the final interocclusal wafer while condylar segment is gently positioned to centric relation position. Fixation of mandibular segments with plates and/or screws in regular fashion. Incision was closed with 4-0 resorbable sutures in a continuous running fashion.
• Bimaxillary orthognathic surgery using patient specific plates
The cutting guide of the maxilla will be placed onto the exposed bony surface and manipulated to the best fit. Then, the guide will be fixed using four 2.0-mm screws to avoid any mobilization during drilling of the reference holes. Sixteen reference holes will be established using the cutting guide; eight on each side. Then, a reciprocating saw will be used to perform the planned Le Fort I osteotomy. After adequate maxillary mobilization and removal of bony interferences, the maxilla will be repositioned using the patient-specific osteosynthesis material guided by the previously established reference holes and fixed using 2.0-mm screws. Then, the mandibular cutting guide will be fixed in the same manner and bilateral sagittal split osteotomy will be carried out. After adequate mobilization, the mandible will be repositioned by the patient-specific osteosynthesis material using the reference holes made by cutting guide and fixed using 2.0-mm screws.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Hassan Fahmy Hassan Alnimr

Country where clinical trial is conducted

Egypt, 

References & Publications (13)

Al-Delayme R, Al-Khen M, Hamdoon Z, Jerjes W. Skeletal and dental relapses after skeletal class III deformity correction surgery: single-jaw versus double-jaw procedures. Oral Surg Oral Med Oral Pathol Oral Radiol. 2013 Apr;115(4):466-72. doi: 10.1016/j.oooo.2012.08.443. Epub 2012 Nov 22. — View Citation

Buijs GJ, van Bakelen NB, Jansma J, de Visscher JG, Hoppenreijs TJ, Bergsma JE, Stegenga B, Bos RR. A randomized clinical trial of biodegradable and titanium fixation systems in maxillofacial surgery. J Dent Res. 2012 Mar;91(3):299-304. doi: 10.1177/0022034511434353. Epub 2012 Jan 23. — View Citation

Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. — View Citation

Hanafy M, Akoush Y, Abou-ElFetouh A, Mounir RM. Precision of orthognathic digital plan transfer using patient-specific cutting guides and osteosynthesis versus mixed analogue-digitally planned surgery: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2020 Jan;49(1):62-68. doi: 10.1016/j.ijom.2019.06.023. Epub 2019 Jun 29. — View Citation

Kotaniemi KVM, Heliövaara A, Kotaniemi M, Stoor P, Leikola J, Palotie T, Suojanen J. Comparison of postoperative skeletal stability of maxillary segments after Le Fort I osteotomy, using patient-specific implant versus mini-plate fixation. J Craniomaxillofac Surg. 2019 Jul;47(7):1020-1030. doi: 10.1016/j.jcms.2019.04.003. Epub 2019 Apr 27. — View Citation

Larsen AJ, Van Sickels JE, Thrash WJ. Postsurgical maxillary movement: a comparison study of bone plate and screw versus wire osseous fixation. Am J Orthod Dentofacial Orthop. 1989 Apr;95(4):334-43. — View Citation

Lee CC, Xhori O, Tannyhill RJ, Kaban LB, Peacock ZS. Variables associated with stability after Le Fort I osteotomy for skeletal class III malocclusion. Int J Oral Maxillofac Surg. 2021 Sep;50(9):1203-1209. doi: 10.1016/j.ijom.2021.02.004. Epub 2021 Feb 28. — View Citation

Ohba S, Nakao N, Nakatani Y, Yoshimura H, Minamizato T, Kawasaki T, Yoshida N, Sano K, Asahina I. Effects of Vertical Movement of the Anterior Nasal Spine on the Maxillary Stability After LeFort I Osteotomy for Pitch Correction. J Craniofac Surg. 2015 Sep;26(6):e481-5. doi: 10.1097/SCS.0000000000001968. — View Citation

Park JH, Kim M, Kim SY, Jung HD, Jung YS. Three-dimensional analysis of maxillary stability after Le Fort I osteotomy using hydroxyapatite/poly-L-lactide plate. J Craniomaxillofac Surg. 2016 Apr;44(4):421-6. doi: 10.1016/j.jcms.2016.01.011. Epub 2016 Jan 19. — View Citation

Ramos VF, Pinto LAPF, Basting RT. Force and deformation stresses in customized and non-customized plates during simulation of advancement genioplasty. J Craniomaxillofac Surg. 2017 Nov;45(11):1820-1827. doi: 10.1016/j.jcms.2017.08.021. Epub 2017 Aug 31. — View Citation

Stokbro K, Borg SW, Andersen MØ, Thygesen T. Patient-specific 3D printed plates improve stability of Le Fort 1 osteotomies in vitro. J Craniomaxillofac Surg. 2019 Mar;47(3):394-399. doi: 10.1016/j.jcms.2018.12.015. Epub 2019 Jan 3. — View Citation

Suojanen J, Leikola J, Stoor P. The use of patient-specific implants in orthognathic surgery: A series of 32 maxillary osteotomy patients. J Craniomaxillofac Surg. 2016 Dec;44(12):1913-1916. doi: 10.1016/j.jcms.2016.09.008. Epub 2016 Sep 23. — View Citation

Wangsrimongkol B, Flores RL, Staffenberg DA, Rodriguez ED, Shetye PR. Skeletal and Dental Correction and Stability Following LeFort I Advancement in Patients With Cleft Lip and Palate With Mild, Moderate, and Severe Maxillary Hypoplasia. Cleft Palate Craniofac J. 2022 Jan;59(1):98-109. doi: 10.1177/1055665621996108. Epub 2021 Mar 15. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal relapse of Le Fort I osteotomy	Skeletal relapse will be assessed through measuring Linear deviations (DT) between the immediate postoperative (T1) and the 12 months postoperative position (T2) in Mimics 19.0 software using hard tissue reference points (A point, Anterior nasal spine, posterior nasal spine, Incisive foramen, Right side Greater palatine foramen, Left side Greater palatine foramen) in relation to three reference planes (Frankfort horizontal plane (FHP), coronal plane, and mid-facial plane (MFP)). Measurements from the reference points to the FHP indicated vertical deviation, to the coronal plane indicated anteroposterior deviation, and to the MFP indicated mediolateral deviation. measurements will be in millimeters.	Linear deviations between immediate postoperative and 12 months postoperative position