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

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ClinicalTrials.gov Identifier: NCT04021836
Recruitment Status : Not yet recruiting
First Posted : July 16, 2019
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Afraa Bushra Abdelkarim Jubara, Cairo University

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


Condition or disease Intervention/treatment Phase
Quality of Life Other: 3d evaluation of nasolabial change Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three dimensional evaluation of nasolabial changes following classic vs without alar base suture after Le Fort I osteotomy
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Three Dimensional Evaluation of Nasolabial Changes Following Classic vs Without Alar Base Suture After Le Fort I Osteotomy
Estimated Study Start Date : July 15, 2019
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : July 15, 2020

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Widening of alar base [ Time Frame: 6 months ]
    Widening of alar base


Secondary Outcome Measures :
  1. Nasal volume [ Time Frame: 6 months ]
    Nasal volume



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Afraa Bushra Abdelkarim Jubara, Dr afraa bushra abdelkarim jubara, Cairo University
ClinicalTrials.gov Identifier: NCT04021836     History of Changes
Other Study ID Numbers: 3DENB
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No