Three Dimensional Evaluation of Nasolabial Changes Follow... | NCT04021836

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

NCT04021836

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 16, 2019Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Quality of Life

Interventions

3d evaluation of nasolabial change

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2019Estimated

Primary Completion Date

Jul 15, 2020Estimated

Completion Date

Jul 15, 2020Estimated

First Submitted Date

Jul 13, 2019

First Submission Date that Met QC Criteria

Jul 15, 2019

First Posted Date

Jul 16, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2019

Last Update Posted Date

Jul 16, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Afraa Bushra Abdelkarim Jubara, Dr afraa bushra abdelkarim jubara, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Le Fort I osteotomy

A randomized controlled clinical trial

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
3d evaluation of naso labial changes using alar cinch suture	Other		Other: 3d evaluation of nasolabial change
3d evaluation of nasolabial change without Alar cinch	Other		Other: 3d evaluation of nasolabial change

Interventions

Name	Type	Description	Arm Group Labels	Other Names
3d evaluation of nasolabial change	Other	Evaluation of With vs without ala cinch suture after lefort 1 osteotomy	3d evaluation of naso labial changes using alar cinch suture

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Nasal volume	Nasal volume	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
Absence of growth.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided