The Use of Bone-borne Guides in Orthognathic Surgery Cases

Dentofacial Deformities Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04224805
• Other study ID #: AlexandriaU- FacDentistry
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: January 2020
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with dentofacial deformity requiring Le Fort I osteotomy

Exclusion Criteria:

• Patients with severe asymmetry

Related Conditions & MeSH terms

• Dentofacial Deformities

Intervention

Device:
• Bone-borne CAD/CAM splint
3D printed splint that repositions the maxilla with the zygomatic buttress as a reference.
• 3D interocclusal conventional splint
Interocclusal splint that relies on the centric relation of the condyle as well as occlusion.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Error of superimposition	Superimposition error between planned and actual maxillary position	2 weeks
Secondary	Visual Analogue Scale	Pain assessed by score from 0 to 10 with 0 no pain and 10 severe unbearable pain.	3 months
Secondary	Procedure duration	Time of the surgery using the splint	1 day