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Completed

NCT Number: NCT06281197

Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume

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.

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Key information

Conditions

Maxillofacial Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Selin Çelebi

Kayseri, Meligazi, 38320, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional

Procedure

Le Fort I osteotomy performed with conventional Le Fort

Other names: Group II

Subspinal

Procedure

Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts

Other names: Group I

Primary outcomes

  1. Evaluation of Septum Deviation

    Time frame: up to six months

    This angle value was measured and recorded in the CBCT images taken before the surgery and at the 6th month after the surgery of each patient. If the angle in the preoperative view is smaller than the angle in the postoperative view, there is a decrease in septum deviation; If it is large, it was accepted that there was an increase in septum deviation.

  2. Evaluation of Nasal Airway

    Time frame: up to six months

    CBCT scans were scanned for anatomical landmarks to adjust the volume analyzed by automatic segmentation in NemoFAB. Dens endpoint of the axis and nasion were found to be the most consistent at the anterior cranial and posterior caudal borders in the mid-sagittal plane The lateral borders were determined as the most lateral part of the nasal cavity. These markers were used to define the cubic area of interest (ROI), which includes the cranial cavity up to the maxillary base. In the sagittal tomography section, the nasal airway volume was measured in cc on the section taken from the midline.

Secondary outcomes

  1. nasal obstruction scale evaluation

    Time frame: up to six months

    The patients filled out the form about NOSE scales in the preoperative evaluation period and the postoperative 6th month, and the sum of the score values given for each question in the questionnaire was calculated and the total scores were recorded

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Feb 28, 2024
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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