Clinical trial NCT03636178: 3D Evaluation of Nasolabial Changes Following Classic Versus Modified Alar Base Suture After Le Fort I Osteotomy
Official title: Three Dimensional Evaluation of Nasolabial Changes Following Classic Versus Modified Alar Base Suture After Le Fort I Osteotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Le Fort; I
Keywords: alar base
le fort I osteotomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility 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.

Primary outcomes:
measure: Widening of the alar base
timeFrame: 6 months postoperatively
Secondary outcomes:
measure: Nasal volume
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
Study officials:
References: