The Use of Bone-borne Guides in Orthognathic Surgery Cases

Not Applicable

Completed

• Conditions: Dentofacial Deformities
• Interventions: Device: 3D interocclusal conventional splint; Device: Bone-borne CAD/CAM splint

• Registration Number: NCT04224805
• Lead Sponsor: Alexandria University

Brief Summary

The present study was conducted to evaluate a new design of the intermediate stent that is used in orthognathic surgery cases requiring Le Fort I osteotomy. The new design relied on referencing the maxillary segment to the zygomatic buttress. The study was carried out as a randomized controlled clinical trial in which 16 patients were enrolled according to the inclusion and exclusion criteria. In control group (n=8) conventional interocclusal splint was used and in study group (n=8) the proposed intermediate stent was used.

Detailed Description

Background: Dentofacial deformities have many negative consequences in the form and function of head and neck region. This includes breathing, swallowing, speech and temporomandibular disorders. It is estimated that in about 19% of orthodontic patients, orthognathic surgery is required along with the orthodontic procedure. The introduction of CAD/CAM technology in orthognathic surgery planning has facilitated the procedure and allowed for more predicted results. Aim of this study: The aim of the present study is to propose a new design of the intermediate stent that relates the mobilized maxilla to a fixed anatomical landmark in the skull which would allow for more accurate positioning of the maxilla during orthognathic surgery. Materials and methods: This study was conducted on sixteen patients who have been undergone Le Fort I osteotomy procedure. Eight of them (group A) were treated via a conventional stent while the other eight patients (group B) via a CAD/CAM bone-borne stent. Postoperative patient evaluation was performed by comparing the predicted maxillary position to the resultant position postoperatively. This was done via 3D reconstruction CT scans.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Patients with dentofacial deformity requiring Le Fort I osteotomy

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Exclusion Criteria

• Patients with severe asymmetry

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	3D interocclusal conventional splint	Interocclusal conventional splint is used to reposition the maxilla.
Study	Bone-borne CAD/CAM splint	Bone-borne splint is used to reposition the maxilla.

Primary Outcome Measures

Name	Time	Method
Error of superimposition	2 weeks	Superimposition error between planned and actual maxillary position

Secondary Outcome Measures

Name	Time	Method
Procedure duration	1 day	Time of the surgery using the splint
Visual Analogue Scale	3 months	Pain assessed by score from 0 to 10 with 0 no pain and 10 severe unbearable pain.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt