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Completed

NCT Number: NCT06132906

Comparison Between Two Techniques to Reposition the Maxilla After le Fort 1

clinical and radiographic comparison between novel locating guide design with pre-bent titanium plates and 3d printed intermediate wafer to reposition the maxilla after Le Fort 1 osteotomy in orthognathic surgery (randomized controlled clinical trial)

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Key information

Conditions

Dentofacial Deformities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Le Fort; I Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year–42 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University, Faculty of dentistry

Alexandria, 21619, Egypt

About this study

Eligible patients will be allocated randomly into 2 equal groups with 7 patients in each group according to the method that will be used to reposition the maxilla by simple randomization using computer generated random numbers. Group 1 (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates on 3d model. Group 2 (Control group) will be treated with Intermediate wafer.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients requiring Le Fort I osteotomy will be selected including those suffering from skeletal malocclusion (Class II or Class III), midface hypoplasia or vertical maxillary excess.

Exclusion criteria

cleft lip and palate. skeletal disharmony due to trauma or severe facial asymmetry. significant medical condition.

Treatment and study plan

Orthognathic surgery (lefort1)

Procedure
  • All patients will be treated under general anesthesia.
  • The surgical field will be scrubbed with povidone-iodine surgical scrub solution, followed by draping of the patient with sterile towels exposing only the area of surgery.
  • The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows:
  • External reference marking
  • Incision and subperiosteal dissection
  • Maxillary osteotomy
  • Pterygomaxillary disjunction,
  • Septal, vomerine, and lateral nasal osteotomies
  • Down fracture
  • Mobilization of the maxilla
  • Application of stent in one group and the locating guide in the other group.
  • Maxillary fixation
  • Occlusal evaluation
  • Wound debridement and closure

Primary outcomes

  1. Radiographic evaluation of accuracy by superimposition

    Time frame: 2 weeks

    Postoperative CBCT was obtained after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using 3-matic software in Mimics innovation suite software package. The preoperative planned final maxillary position was compared with the actual postoperative maxillary position by superimposing both STL models on each other with anatomical points along the orbital rims and the zygomatic arch used as reference points for alignment. The N points registration tool was used to obtain the alignment. Afterwards, using trim tool all parts were trimmed except that between the plates and the maxillary teeth crowns. Then the part comparison analysis tool was used to calculate the accuracy of the superimposition of the maxillary segment using point-based analysis algorithm after 2 weeks of surgery for comparison with the expected position of the maxilla in the preoperative virtual plan using Mimics innovation suite software.

  2. The surgery duration

    Time frame: 1 week

    The time taken between performing the Le fort 1 osteotomy till completion of plate fixation will be measured.

Secondary outcomes

  1. Postoperative Pain

    Time frame: after one week, two weeks

    Will be assessed through a 10-point Visual Analogue Scale (VAS)

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Comparison of Accuracy Between Novel Locating Guide Design With Pre-bent Titanium Plates and 3d Printed Intermediate Wafer to Reposition the Maxilla After le Fort 1 Osteotomy in Orthognathic Surgery

Acronym: orthognathic

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 15, 2023
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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