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

NCT06132906 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-11-15

No results posted yet for this study

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

Interventions

PROCEDURE

Orthognathic surgery (lefort1)

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

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2023-10-01
Completion
2023-11-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06132906 on ClinicalTrials.gov