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

NCT05151042 | Unknown DMC

• 1 other identifier: OMFS 3 - 3 - 7
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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. .

Conditions

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

Keywords

Orthognathic Surgery; Orthognathic Surgical Procedures; Mandibular Advancement; Osteotomy, Sagittal Split Ramus; Mandibular Osteotomy; Computer-aided Design; 3D printing; Computer guided surgery; splint-less; computer-aided surgical simulation; virtual Mock-up surgery; Custom plate; 3D planning; Surgical guide; Osteotomy guide; repositioning guide; computer-assisted orthognathic surgery; virtual planning accuracy

Outcome Measures

Primary Outcomes (6)

• Postop occlusal translational discrepancy (T3):

  measured in mm from sagittal, axial, and coronal postop CT images. Measuring error and deviation of postoperative bony segments to the preoperative virtual plan.

  Outcomes will be assessed with immediate postoperative CT at T3 (week 3).

• Postop occlusal translational discrepancy (T6):

  measured in mm from sagittal, axial, and coronal postop CT images. Measuring error and deviation of postoperative bony segments to the preoperative virtual plan.

  Outcomes will be assessed with immediate postoperative CT at T4 (week 27).

• Postop occlusion rotation and deviation (T3):

  measured in degrees from 3D objects preoperative 3D cephalometric landmarks. comparing postoperative occlusal plane rotational deviation in reference to preoperative planned occlusion.

  Outcomes will be assessed with immediate postoperative CT at T3 (week 3).

• Postop occlusion rotation and deviation (T27):

  measured in degrees from 3D objects preoperative 3D cephalometric landmarks. comparing postoperative occlusal plane rotational deviation in reference to preoperative planned occlusion.

  Outcomes will be assessed with immediate postoperative CT at T4 (week 27).

• 3D spatial deviation error (T3):

  Absolute point to point 3D measurements in the 3D virtual environment of the postop 3D bony segments in reference to the preop objects.

  Outcomes will be assessed with immediate postoperative CT at T3 (week 3).

• 3D spatial deviation error (T27):

  Absolute point to point 3D measurements in the 3D virtual environment of the postop 3D bony segments in reference to the preop objects.

  Outcomes will be assessed with immediate postoperative CT at T4 (week 27).

Secondary Outcomes (2)

• Relapse over time:

  at week 27, after 6 weeks

• Operative Time

  immediate postop.

Study Arms (2)

Group I

EXPERIMENTAL

Distal segments repositioning using osteotomy/plate locating bone-borne surgical guide (wafer-less approach).

Procedure: wafer-less approach

Group II

ACTIVE COMPARATOR

Distal segments repositioning using preoperative and final wafers.

Procedure: Computer Guided orthognathic surgery using occlusal wafers

Interventions

wafer-less approach PROCEDURE

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.

Group I

Computer Guided orthognathic surgery using occlusal wafers PROCEDURE

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.

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients in need of bilateral sagittal split osteotomy for mandibular repositioning.
• All patients are free from any systemic disease that may affect normal bone healing.
• Sufficient dentition to reproduce the occlusal relationships
• Patient's consent to participate

You may not qualify if:

• Patients with any systemic disease that may affect normal healing
• Intra-bony lesions or infections that may interfere with surgery.
• Previous orthognathic surgeries.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mohamed Omara

Cairo, El-Manial, 12613, Egypt

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Diseases; Mandibular Diseases

Study Officials

• Mohamed Omara, PhD

  Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University

  STUDY CHAIR

• Hesham O Morsi, MDSc

  Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hesham O Morsi, MDSc

CONTACT

+2011224845647; hesham.morsi@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: December 9, 2021
• Study Start: November 15, 2021
• Primary Completion: September 1, 2022
• Study Completion: March 1, 2023
• Last Updated: December 9, 2021

Record last verified: 2021-11

Locations

EG (1)