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The Use of Bone-borne Guides in Orthognathic Surgery Cases

A

Alexandria University

Status

Completed

Conditions

Dentofacial Deformities

Treatments

Device: Bone-borne CAD/CAM splint
Device: 3D interocclusal conventional splint

Study type

Interventional

Funder types

Other

Identifiers

NCT04224805
AlexandriaU- FacDentistry

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with dentofacial deformity requiring Le Fort I osteotomy

Exclusion criteria

  • Patients with severe asymmetry

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

Control
Active Comparator group
Description:
Interocclusal conventional splint is used to reposition the maxilla.
Treatment:
Device: 3D interocclusal conventional splint
Study
Experimental group
Description:
Bone-borne splint is used to reposition the maxilla.
Treatment:
Device: Bone-borne CAD/CAM splint

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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