NCT06233188

Brief Summary

The goal of this clinical trial is to show the effect of patient specific lateral nasal wall osteotomy to the pterygomaxillary separation during Le Fort I down-fracture. Participants will be divided into two treatment groups. In study group, surgery planned according to the patients' indivudial anatomy and in the conventional group, surgery planned according to mean anatomical datas. Researchers will compare patient specific lateral nasal wall osteotomy to see if it affects the pterygomaxillary junction seperation during le fort I downfracture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

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

May 3, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 31, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 10, 2024

Last Update Submit

January 22, 2024

Conditions

MalocclusionOpen BiteLe Fort; IOrthognathic Surgery

Keywords

orthognatic surgeryle fort Iarterial bleedingdown fracturelateral nasal wallpterygomaxillary junction

Outcome Measures

Primary Outcomes (1)

  • lateral nasal wall separation

    The primary outcome variable is lateral nasal wall separation: Type 1 Separation from the osteotomy line Type 2 Separation 2-4 mm above the osteotomy line Type 3 Separation 4 mm or more above the osteotomy line

    1 year

Secondary Outcomes (1)

  • pterygomaxillary junction separation

    1 year

Study Arms (2)

study group

ACTIVE COMPARATOR

In the study group, lateral nasal osteotomy was performed 2 mm less than the measured distance in the axial section

Procedure: orthogantic surgery

conventional group

ACTIVE COMPARATOR

n the conventional osteotomy group, lateral nasal osteotomy was performed 25 mm for female and 30 mm for male patients, as suggested in the literature.

Procedure: orthogantic surgery

Interventions

orthogantic surgeryPROCEDURE

surgery that correcting the maxilla and mandible related with each other

conventional groupstudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • orthognathic surgery to treat malocclusion
  • sleep apnea
  • jaw asymmetry

You may not qualify if:

  • cleft lip and palate
  • previous orthognathic surgery
  • rhinoplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taha Pergel

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

MalocclusionOpen Bite

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

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 Profesor

Study Record Dates

First Submitted

January 10, 2024

First Posted

January 31, 2024

Study Start

May 3, 2023

Primary Completion

October 15, 2023

Study Completion

December 5, 2023

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

TU(1)