Digital Occlusal Wafer Versus Waferless Distal Segment Repositioning for BSSO in Skeletal Mandibular Deformities

NCT05151042 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-12-09

No results posted yet for this study

Summary

Research studies continues to attempt testing modifications to refine the treatment protocols through computer assisted design or computer-generated surgical Wafer splints, have greatly revolutionized the incorporation of digital imaging and 3D design in Orthognathic surgery.

Integrating computer guided technology in orthognathic surgery aims to to simplify workup and reduce surgical errors, eliminate occlusal discrepancy, increase the realignment accuracy of the distal segments according to the preoperative plan. Implementing a waferless technique raised the question of efficiency versus the use of occlusal wafers and whether it has a significant measurable effect on the surgical outcome and objectives.

Rationale for conducting this study is to assess the difference between the effect of computer guided waferless technique and computer guided technique with occlusal wafer on accuracy of postoperative occlusion and condylar position.

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Conditions

  • Maxillofacial Abnormalities
  • Jaw Abnormalities
  • Prognathism
  • Retrognathia
  • Micrognathism
  • Dentofacial Deformities
  • Congenital Abnormalities
  • Craniofacial Abnormalities

Interventions

PROCEDURE

wafer-less approach

Using the software, 3D digitized bony mandible will be virtually osteotomized and repositioned to the new postoperative position. CAD/CAM generated preoperative wafer will be placed on the lower arch dentition, the guide has an extension to guide medial, vertical, oblique cuts as well as screw holes for reference landmarks for proximal segment \& tooth bearing segment. Drilling of all the reference landmarks on the proximal segment and locating medial, vertical, oblique cuts. Removal of guide, then BSSO is performed. The final wafer is placed, the guiding hole on the proximal segment will then be realigned with the previously drilled screw holes, fixation using mono cortical screws then drilling screw holes for plate fixation. Fixation of the osteotomy using 2.0 mm pre-bent mini plates.

PROCEDURE

Computer Guided orthognathic surgery using occlusal wafers

Using the software, 3D digitized bony mandible will be virtually osteotomized and repositioned to the new postoperative position. dental casts will be scanned dental casts are superimposed to the CT cuts into the virtual software environment to produce final wafer CAD/CAM repositioning guide. the generated preoperative wafer will be placed on the lower arch dentition, the guide has an extension to guide medial, vertical, oblique cuts as well as screw holes for reference landmarks for proximal segment \& tooth bearing segment. Drilling of all the reference landmarks on the proximal segment and locating medial, vertical, oblique cuts. Removal of guide, then BSSO is performed. The final wafer is placed, the guiding hole on the proximal segment will then be realigned with the previously drilled screw holes, fixation using mono cortical screws then drilling screw holes for plate fixation. Fixation of the osteotomy using 2.0 mm pre-bent mini plates.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Mohamed Omara, PhD · Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University

  • Hesham O Morsi, MDSc · Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-09-30
Completion
2023-03-31

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 NCT05151042 on ClinicalTrials.gov