3D Evaluation of Nasolabial Changes Following Classic Versus Modified Alar Base Suture After Le Fort I Osteotomy

NCT03636178 | Unknown DMC

• 1 other identifier: CEBD-CU-2018-07-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Three dimensional evaluation of nasolabial changes following classic versus modified alar cinch suture after Le Fort I osteotomy using cone beam computed tomography

Conditions

Le Fort; I

Keywords

alar base; le fort I osteotomy

Outcome Measures

Primary Outcomes (1)

• Widening of the alar base

  Postoperative increase in the alar base width in millimeters(mm) in comparison to the normal preoperative alar base width

  6 months postoperatively

Secondary Outcomes (1)

• Nasal volume

  6 months postoperatively

Study Arms (2)

1st group

OTHER

20 patients out of 40 will be enrolled into the study including males and females above 18 years old

Procedure: Classic alar base suture technique

2nd group

OTHER

20 patients out of 40 will be enrolled in the study including males and females above 18 years old

Procedure: Modified alar base suture technique

Interventions

Classic alar base suture technique PROCEDURE

An index finger will be used to apply extraoral pressure on the alar base region, and a dentate forceps will grasp this tissue through the intraoral incision. A suture bite will be taken at this point through the tissue previously held by the forceps. The same procedure will be applied on the opposite side. After passing the suture on both sides, it will be tightened with attention to the alar base response. If the alar base suture will be judged to be adequate, the vestibular incision will then be closed in a routine fashion, with or without performing a V-Y lip closure

1st group

Modified alar base suture technique PROCEDURE

The alar base will be marked with 3 landmarks: left alar base (point LAB), columella (point C), and right alar base (point RAB). A needle will be inserted through the skin at the nasofacial skin fold and exited through the fibroareolar tissue. A nonabsorbable suture without a needle will be inserted through the needle from the oral cavity to the outside. The needle will be retracted through point RAB without leaving the skin point, then returned to the oral cavity in a medial position. Finally the needle will be retracted from point RAB, leaving the suture through the soft tissue. The same procedure will be repeated on the other side. The 2 free ends of the sutures will be then tied together after passing through a hole made in the nasal spine.

2nd group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
• Absence of clefts.
• 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.
• History of surgical operation in nasal region.
• Facial asymmetry.
• Patients with accompanying craniofacial syndromes.
• Patients with any diseases that compromise bone or soft tissue healing.
• Anterior open bite cases
• Medically compromised patients not fit for general anaesthesia.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blind clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial surgeon

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: August 17, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: April 1, 2021
• Last Updated: September 4, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share