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

NCT04021836 | Unknown

• 1 other identifier: 3DENB
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

• Widening of alar base

  Widening of alar base

  6 months

Secondary Outcomes (1)

• Nasal volume

  6 months

Study Arms (2)

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

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; 3d evaluation of nasolabial change without Alar cinch

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr afraa bushra abdelkarim jubara

Model Details: Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy

Study Record Dates

• First Submitted: July 13, 2019
• First Posted: July 16, 2019
• Study Start: July 15, 2019
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share