NCT04224805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.1 years

First QC Date

January 7, 2020

Last Update Submit

January 8, 2020

Conditions

Dentofacial Deformities

Keywords

Le FortOrthognathic surgeryVirtual surgical planning

Outcome Measures

Primary Outcomes (1)

  • Error of superimposition

    Superimposition error between planned and actual maxillary position

    2 weeks

Secondary Outcomes (2)

  • Visual Analogue Scale

    3 months

  • Procedure duration

    1 day

Study Arms (2)

Control

ACTIVE COMPARATOR

Interocclusal conventional splint is used to reposition the maxilla.

Device: 3D interocclusal conventional splint

Study

EXPERIMENTAL

Bone-borne splint is used to reposition the maxilla.

Device: Bone-borne CAD/CAM splint

Interventions

Bone-borne CAD/CAM splintDEVICE

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

Study
3D interocclusal conventional splintDEVICE

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

Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with dentofacial deformity requiring Le Fort I osteotomy

You may not qualify if:

  • Patients with severe asymmetry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 22111, Egypt

Location

MeSH Terms

Conditions

Dentofacial Deformities

Condition Hierarchy (Ancestors)

Maxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesStomatognathic System AbnormalitiesStomatognathic DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 13, 2020

Study Start

November 1, 2018

Primary Completion

December 1, 2019

Study Completion

December 30, 2019

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

EG(1)