Clinical trial NCT06281197: Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume
Official title: Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillofacial Abnormalities
Keywords: Subspinal Le Fort Osteotomy
Nasal airway
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind
Primary purpose: TREATMENT

Brief summary: After the description of Le Fort fractures, maxillary osteotomies are used to correct dentofacial deformities. The profile changes on nasolabial region resulting from a Le Fort I osteotomy, also that affects nasal airway. The Subspinal Le Fort I osteotomy (SLFIO) describe to prevent undesirable soft tissue changes. In the literature, too many articles have reported the effectiveness of SLFIO in preventing nasal deformation. However, there is no study to evaluate the nasal volume or septum deviation.

Detailed description: The purpose of this study was objectively and subjectively to compare the effect of Subspinal Le Fort I Osteotomy and Conventional Le Fort I Osteotomy on nasal airway volume and septum deviation without additional modification such as Ans Reduction, Alar Cinch Suture, V-Y closure.

Surgical procedure; Patients were underwent general anesthesia for bimaxillary orthognathic surgery.

The mucoperiosteal flap was raised to expose the bilateral infraorbital foramina, aperture pyriformis, zygomaticomaxillary, and pterygomaxillary buttress. No dissection was performed between the nasal mucosa and the ANS of the patients in Subspinal Le Fort osteotomy group.A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery. In Conventional osteotomy group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation. In both groups, osteotomes and pterygoid plaques, nasal septum, and lateral nasal walls were separated.

Follow up:

septum deviation and nasal. airway volume value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient.

Eligibility criteria: Inclusion Criteria:

* aged 18-40, ASA I, without systemic disease, without any drug allergy, and without a history of NSAID use in the week before the operation.

Exclusion Criteria:

* ASA II or higher, hepatic or renal dysfunction, neuropathic disease, long-term use of NSAIDs or opioid-derived drugs, a history of allergic reaction to drugs, pain, swelling, inflammation in the head and neck region before the operation, pregnant and breastfeeding with a history of cleft lip and palate and rhinoplasty surgery

Primary outcomes:
measure: Evaluation of Septum Deviation
timeFrame: up to six months
measure: Evaluation of Nasal Airway
timeFrame: up to six months
Secondary outcomes:
measure: nasal obstruction scale evaluation
timeFrame: up to six months
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Selin Çelebi
state: Meligazi
Study officials:
References:
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