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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04224805
Other study ID # AlexandriaU- FacDentistry
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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