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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03636178
Enrollment
40
Registered
2018-08-17
Start date
2018-09-30
Completion date
2021-04-30
Last updated
2018-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Le Fort; I

Keywords

alar base, le fort I osteotomy

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.

Interventions

PROCEDUREClassic 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

PROCEDUREModified 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double blind clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Widening of the alar base6 months postoperativelyPostoperative increase in the alar base width in millimeters(mm) in comparison to the normal preoperative alar base width

Secondary

MeasureTime frameDescription
Nasal volume6 months postoperativelyPostoperative increase or decrease in the nasal volume in cubic millimeters in comparison to the normal preoperative nasal volume

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026