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

NCT06132906 | Completed

• 1 other identifier: orthognathicalexu
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Dentofacial Deformities; Le Fort; I

Keywords

orthognathic; virtual planning

Outcome Measures

Primary Outcomes (2)

• Radiographic evaluation of accuracy by superimposition

  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 weeks

• The surgery duration

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

  1 week

Secondary Outcomes (1)

• Postoperative Pain

  after one week, two weeks

Study Arms (2)

(Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates

EXPERIMENTAL

After le fort 1 osteotomy, locating guides will be used to reposition the maxilla with pre-bent plates.

Procedure: Orthognathic surgery (lefort1)

(Control group) will be treated with Intermediate wafer.

ACTIVE COMPARATOR

After le fort 1 osteotomy, Intermediate wafer will be used with intermaxillary fixation.

Procedure: Orthognathic surgery (lefort1)

Interventions

Orthognathic surgery (lefort1) PROCEDURE

1. All patients will be treated under general anesthesia. 2. 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. 3. The surgical procedure of Le Fort I osteotomy will be performed which can be summarized as follows: 1. External reference marking 2. Incision and subperiosteal dissection 3. Maxillary osteotomy 4. Pterygomaxillary disjunction, 5. Septal, vomerine, and lateral nasal osteotomies 6. Down fracture 7. Mobilization of the maxilla 8. Application of stent in one group and the locating guide in the other group. 9. Maxillary fixation 10. Occlusal evaluation 11. Wound debridement and closure

(Control group) will be treated with Intermediate wafer.; (Study group) will be treated with locating guides to reposition the maxilla with pre-bent plates

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University, Faculty of dentistry

Alexandria, 21619, Egypt

Location

MeSH Terms

Conditions

Dentofacial Deformities

Interventions

Orthognathic Surgery

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

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 15, 2023
• Study Start: November 15, 2022
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

EG (1)