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The Use of Bone-borne Guides in Orthognathic Surgery Cases

NCT04224805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-01-13

No results posted yet for this study

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.

Conditions

  • Dentofacial Deformities

Interventions

DEVICE

Bone-borne CAD/CAM splint

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

DEVICE

3D interocclusal conventional splint

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

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2019-12-01
Completion
2019-12-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04224805 on ClinicalTrials.gov