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

• ClinicalTrials.gov Identifier: NCT03636178
• Recruitment Status: Unknown
• First Posted: August 17, 2018
• Last Update Posted: September 4, 2018
• Sponsor: Cairo University
• Information provided by (Responsible Party): Amr Samy, Cairo University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Le Fort; I	Procedure: Classic alar base suture technique; Procedure: Modified alar base suture technique	Not Applicable

Detailed Description:

Intra operative procedures: (For all groups) All surgical operations will be performed or supervised by one of the authors (MdK). Intraoperative antibiotics will be given(1000 mg cefazolin and 500 mg metronidazole). After nasotracheal intubation, the mucobuccal fold of the maxilla will be infiltrated with local anaesthetic (articaine ; Ultracain DS Forte). The Le Fort I procedure will be started with an incision in the gingivobuccal sulcus from the canine on the one side to the canine on the other side. After elevation of the mucoperiosteum and nasal mucosa, the osteotomy line will be designed with a fine burr, after which the cut will be made with a reciprocal saw. The lateral nasal walls and nasal septum will be osteotomized with a nasal osteotome. The piriform aperture and when necessary the nasal spine will be rounded off. After mobilization of the maxilla, it will be positioned in the planned position using an acrylic wafer. Fixation will be performed with four 1.5-mm miniplates, one paranasal and one on the buttress on each side. The mucosa will be closed with a 4-0 Vicryl suture (Ethicon ; Johnson and Johnson Medical, Norderstedt, Germany).

The alar cinch procedure will be performed through the intraoral incision as follows:

In the comparator ( control ) group:

The classic method of alar cinching will be performed in the following manner: 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.

In the intervention group:

The alar base will be marked with 3 landmarks: the nasofacial skin fold at the left alar base (point LAB), the middle of the columella (point C), and the nasofacial skin fold at the 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double blind clinical trial
• Primary Purpose: Prevention
• Official Title: Three Dimensional Evaluation of Nasolabial Changes Following Classic Versus Modified Alar Base Suture After Le Fort I Osteotomy
• Estimated Study Start Date: September 2018
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: April 2021

Arms and Interventions

Arm	Intervention/treatment
1st group; 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; 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
2nd group; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Widening of the alar base [ Time Frame: 6 months postoperatively ]
   Postoperative increase in the alar base width in millimeters(mm) in comparison to the normal preoperative alar base width

Secondary Outcome Measures :

1. Nasal volume [ Time Frame: 6 months postoperatively ]
   Postoperative increase or decrease in the nasal volume in cubic millimeters in comparison to the normal preoperative nasal volume

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Adult patients with skeletal maxillomandibular deformity indicated for surgical correction by Le Fort I osteotomy.
2. Absence of clefts.
3. Absence of growth.
4. Patients must be willing for the surgical procedure and follow-up, with his informed consent.

Exclusion Criteria:

1. History of facial trauma with fractures of facial bones.
2. History of surgical operation in nasal region.
3. Facial asymmetry.
4. Patients with accompanying craniofacial syndromes.
5. Patients with any diseases that compromise bone or soft tissue healing.
6. Anterior open bite cases
7. Medically compromised patients not fit for general anaesthesia.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Amr Samy, Oral and Maxillofacial surgeon, Cairo University
• ClinicalTrials.gov Identifier: NCT03636178
• Other Study ID Numbers: CEBD-CU-2018-07-01
• First Posted: August 17, 2018
• Last Update Posted: September 4, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Amr Samy, Cairo University:

alar base; le fort I osteotomy

Additional relevant MeSH terms:

Daminozide; Plant Growth Regulators; Growth Substances; Physiological Effects of Drugs