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NCT04021836 Clinical Trial

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

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04021836
Other study ID # 3DENB
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 15, 2019
Est. completion date July 15, 2020

Study information
Verified date July 2019
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Le Fort I osteotomy

A randomized controlled clinical trial

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date July 15, 2020
Est. primary completion date July 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• 3d evaluation of nasolabial change
Evaluation of With vs without ala cinch suture after lefort 1 osteotomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary Widening of alar base Widening of alar base 6 months
Secondary Nasal volume Nasal volume 6 months
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