Accuracy of CAD/CAM Cutting Guides and Customized Titanium Plates for Virtual Planning Transfer in Bimaxillary Orthognathic Surgeries

In this research, we aim to use CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.

Study Overview

• Status: Unknown
• Conditions: Evaluation of the Accuracy of Transferring the Virtual Planning to the Surgery
• Intervention / Treatment: Procedure: orthognathic surgery

Detailed Description

Intervention:

1. Diagnostic procedure:

   All Patients will be selected according to inclusion and exclusion criteria & Comprehensive clinical examination and understanding of patients' chief complains and needs will be carried out.

   Preoperative patient photographs (Frontal, Profile, 45°, smile, and dental occlusion).

   Alginate Impressions of upper & lower jaws will be taken for acquiring diagnostic dental casts.

   A heat-cured acrylic resin stent will be constructed on the stone model. Using the stent, a radiographic stent will be constructed for imaging and planning procedures.

   Cone Beam Computed Topography (CBCT) for the patients will be carried out. All patients will be referred to an orthodontist for presurgical phase of orthodontic treatment for decompensation and to attain stable occlusion in three points in the surgery.

2. Planning procedure:

   All planning procedures are carried out by MZ and under the supervision of AH and MH.

   Computer-aided planning & MCROS design for all patients: All planning will be done using specialized software .

   One virtual 3D anatomic model of the patient will be constructed through thresholding & image fusion.

   Virtual Le Fort I osteotomy and then the maxilla will be virtually adjusted according to the facial symmetry planes and clinical anthropometric analysis. Virtual simulation of the sagittal split of the mandible will be performed and the mandible position adjusted according to the bite registered.

   After settling on the optimum virtual plan, designing of the cutting guides and titanium plates will then be started.

3. Intra-operative procedures:

   The surgical procedures will be carried out by MZ under the supervisor of AH in the Oral & Maxillofacial operating floor on the 8th floor of the faculty of Oral & Dental Medicine new building.

   Scrubbing and draping of the patient will be carried out in a standard fashion according to Anon 2006.

   Local anaesthesia (lidocaine 2%, 1/100000 adrenaline) will be injected intraorally along the incision lines for hemostasis.

   Access through a vestibular intraoral incision for maxilla & Sagittal split incision for mandible will be carried out. Dissection and reflection to reach the bone will be carried out.

   Le Fort I Maxillary & Bilateral Sagittal split mandibular osteotomies will be carried out using the osteotomy cutting guides.

   Complete mobilization of maxillary and mandibular segments. Reposition and fixation of the maxillary & mandibular segments using customized titanium plates.

   The incisions will be closed with continuous mattress resorbable sutures .

4. Post-operative care:

   Patients will start antibiotics 4 hours after the last intraoperative dose (Amoxicillin / Clavulanic acid 625 mg every 8 hours) for 5 days Patients will start analgesics (NSAIDs every 6 hours) for 3 days Mouthwash (Chlorhexidine 0.12%) will be prescribed for 2 more weeks.

5. Criteria for discontinuing or modifying intervention:

   • Difficulty with the use of cutting guides and customized titanium plates.
   • Inaccurate translation of the surgical plan.

6. Strategies to improve adherence to intervention:

   Postoperative orthodontic treatment is necessary after the operation to obtain the final stable occlusion.

7. Concomitant care:

   Not needed.

8. Follow up & Evaluation:

Post-operative treatment will start immediately postoperative (4 hours). The patients will be scheduled for follow-up visits weekly for a month then on a monthly basis for 5 more months.

Within the first week postoperatively CBCT using same parameters will be ordered to calculate the difference between surgical plan and actual outcome will be evaluated.

Patient will be referred back to the orthodontist to receive his postsurgical orthodontics 4-6 weeks postoperatively.

The technique will be evaluated by applying hard tissue parameters to compare the virtual orthognathic planning (P0) with the postoperative result (P1) using 3D cephalometry and image fusion.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
2. Patients with no signs or symptoms of active TMDs.
3. Highly motivated patients.

Exclusion Criteria:

1. Patients who refused to be included in the research.
2. Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
3. Patients with intra-bony lesions or infections that may retard the osteotomy healing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; using CAD/CAM surgical cutting guides for maxilla and mandible and customized titanium plates to guide all osteotomies and fixation of both arches.	Procedure: orthognathic surgery; patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the surgical transfer	Computer software on pre/postoperative CBCT	within first week postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction: Visual analog scale (questionnaire)	Visual analog scale (questionnaire)	one week postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): November 1, 2021

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: CAD/CAM; orthognathic surgery; virtual planning; customized titanium plates; cutting guides
• Other Study ID Numbers: Dr.Zain protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No