Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy

July 15, 2019 updated by: Afraa Bushra Abdelkarim Jubara, Cairo University

Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after

Le Fort I osteotomy

A randomized controlled clinical trial

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
  2. Absence of growth.
  3. Patients must be willing for the surgical procedure and follow-up, with his informed consent.

Exclusion Criteria:

  • 4. History of facial trauma with fractures of facial bones. 5. History of surgical operation in nasal region. 6. Facial asymmetry. 7. Patients with accompanying craniofacial syndromes. 8. Patients with any diseases that compromise bone or soft tissue healing. 9. Anterior open bite cases. 10. Clefts ( lip and palate). 11. Medically compromised patients not fit for general anaesthesia. 12. missing preoperative or postop-erative 3D photographs or CBCT scans 13. multi-segment Le Fort I osteotomy 14. rhinoplasty surgery during or within 1 year after the Le Fort I osteotomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 3d evaluation of naso labial changes using alar cinch suture
Other: 3d evaluation of nasolabial change
Evaluation of With vs without ala cinch suture after lefort 1 osteotomy
Other: 3d evaluation of nasolabial change without Alar cinch
Other: 3d evaluation of nasolabial change
Evaluation of With vs without ala cinch suture after lefort 1 osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Widening of alar base
Time Frame: 6 months
Widening of alar base
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal volume
Time Frame: 6 months
Nasal volume
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 15, 2019

Primary Completion (Anticipated)

July 15, 2020

Study Completion (Anticipated)

July 15, 2020

Study Registration Dates

First Submitted

July 13, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 16, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 3DENB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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