The Use of Bone-borne Guides in Orthognathic Surgery Cases

NCT ID: NCT04224805

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-12-30

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.

Conditions

Dentofacial Deformities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Interocclusal conventional splint is used to reposition the maxilla.

Group Type: ACTIVE_COMPARATOR

3D interocclusal conventional splint

Intervention Type: DEVICE

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

Study

Bone-borne splint is used to reposition the maxilla.

Group Type: EXPERIMENTAL

Bone-borne CAD/CAM splint

Intervention Type: DEVICE

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

Interventions

Bone-borne CAD/CAM splint

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

Intervention Type: DEVICE

3D interocclusal conventional splint

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with dentofacial deformity requiring Le Fort I osteotomy

Exclusion Criteria

• Patients with severe asymmetry

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Haitham Mohammed Abou Eleneen

Assistant lecturer of Oral and Maxillofacial Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

AlexandriaU- FacDentistry

Identifier Type: -

Identifier Source: org_study_id