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The Use of Bone-borne Guides in Orthognathic Surgery Cases

Evaluation of the Use of Bone-borne CAD/CAM Surgical Guides in Orthognathic Surgery Cases Requiring Le Fort I Osteotomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04224805
Enrollment
16
Registered
2020-01-13
Start date
2018-11-01
Completion date
2019-12-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentofacial Deformities

Keywords

Le Fort, Orthognathic surgery, Virtual surgical planning

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.

Interventions

DEVICEBone-borne CAD/CAM splint

3D printed splint that repositions the maxilla with the zygomatic buttress as a reference.

DEVICE3D interocclusal conventional splint

Interocclusal splint that relies on the centric relation of the condyle as well as occlusion.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Patients with dentofacial deformity requiring Le Fort I osteotomy

Exclusion criteria

* Patients with severe asymmetry

Design outcomes

Primary

MeasureTime frameDescription
Error of superimposition2 weeksSuperimposition error between planned and actual maxillary position

Secondary

MeasureTime frameDescription
Visual Analogue Scale3 monthsPain assessed by score from 0 to 10 with 0 no pain and 10 severe unbearable pain.
Procedure duration1 dayTime of the surgery using the splint

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026