Three Dimensional Evaluation of Nasolabial Changes Following Classic Versus Modified Alar Base Suture After Le Fort I Osteotomy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 40
- Primary Endpoint
- Widening of the alar base
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Double blind clinical trial
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
1st group
20 patients out of 40 will be enrolled into the study including males and females above 18 years old
Intervention: Classic alar base suture technique (Procedure)
2nd group
20 patients out of 40 will be enrolled in the study including males and females above 18 years old
Intervention: Modified alar base suture technique (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Nasal volume(6 months postoperatively)
Investigators
Amr Samy
Oral and Maxillofacial surgeon
Cairo University