Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume

NCT06281197 | Completed

• 1 other identifier: 2021/48
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillofacial Abnormalities

Keywords

Subspinal Le Fort Osteotomy; Nasal airway

Outcome Measures

Primary Outcomes (2)

• Evaluation of Septum Deviation

  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.

  up to six months

• Evaluation of Nasal Airway

  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.

  up to six months

Secondary Outcomes (1)

• nasal obstruction scale evaluation

  up to six months

Study Arms (2)

Conventional Group

EXPERIMENTAL

In conventional group, Le Fort I osteotomy was made using a piezosurgical saw after nasal mucosa elevation as usual Le Fort I technique.

Procedure: Conventional

Subspinal Group

ACTIVE COMPARATOR

In Subspinal group, No dissection was performed between the nasal mucosa and the ANS of the patients. Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts . A triangular osteotomy line was created between the maxilla and the ANS with a piezosurgery.

Procedure: Subspinal

Interventions

Conventional PROCEDURE

Le Fort I osteotomy performed with conventional Le Fort

Also known as: Group II

Conventional Group

Subspinal PROCEDURE

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

Also known as: Group I

Subspinal Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Selin Çelebi

Kayseri, Meligazi, 38320, Turkey (Türkiye)

Location

Related Publications (11)

• Guenthner TA, Sather AH, Kern EB. The effect of Le Fort I maxillary impaction on nasal airway resistance. Am J Orthod. 1984 Apr;85(4):308-15. doi: 10.1016/0002-9416(84)90188-x.

  PMID: 6585148 BACKGROUND

• Galbiati G, Maspero C, Giannini L, Guenza GC, Zanoni F, Farronato G. Orthodontic--surgical treatment and respiratory function: rhinomanometric assessment. Minerva Stomatol. 2017 Jun;66(3):91-97. doi: 10.23736/S0026-4970.17.04045-6. Epub 2017 Apr 11.

  PMID: 28399616 BACKGROUND

• Posnick JC, Agnihotri N. Consequences and management of nasal airway obstruction in the dentofacial deformity patient. Curr Opin Otolaryngol Head Neck Surg. 2010 Aug;18(4):323-31. doi: 10.1097/MOO.0b013e32833b9d6f.

  PMID: 20625295 BACKGROUND

• Helal HA, Ghanem MAM, Al-Badawy AM, Abdel Haleem MM, Mousa MH. Histological and Anthropometric Changes in the Aging Nose. Aesthet Surg J. 2019 Aug 22;39(9):943-952. doi: 10.1093/asj/sjy245.

  PMID: 30247560 BACKGROUND

• Schwarz GM, Thrash WJ, Byrd DL, Jacobs JD. Tomographic assessment of nasal septal changes following surgical-orthodontic rapid maxillary expansion. Am J Orthod. 1985 Jan;87(1):39-45. doi: 10.1016/0002-9416(85)90172-1.

  PMID: 3881034 BACKGROUND

• Kaur S, Rai S, Kaur M. Comparison of reliability of lateral cephalogram and computed tomography for assessment of airway space. Niger J Clin Pract. 2014 Sep-Oct;17(5):629-36. doi: 10.4103/1119-3077.141431.

  PMID: 25244276 BACKGROUND

• Goncales ES, Duarte MA, Palmieri C Jr, Zakhary GM, Ghali GE. Retrospective analysis of the effects of orthognathic surgery on the pharyngeal airway space. J Oral Maxillofac Surg. 2014 Nov;72(11):2227-40. doi: 10.1016/j.joms.2014.04.006. Epub 2014 Apr 13.

  PMID: 24985958 BACKGROUND

• Montgomery WM, Vig PS, Staab EV, Matteson SR. Computed tomography: a three-dimensional study of the nasal airway. Am J Orthod. 1979 Oct;76(4):363-75. doi: 10.1016/0002-9416(79)90223-9.

  PMID: 291340 BACKGROUND

• Kunkel M, Hochban W. The influence of maxillary osteotomy on nasal airway patency and geometry. Mund Kiefer Gesichtschir. 1997 Jul;1(4):194-8. doi: 10.1007/BF03043550.

  PMID: 9384792 BACKGROUND

• Erbe M, Lehotay M, Gode U, Wigand ME, Neukam FW. Nasal airway changes after Le Fort I--impaction and advancement: anatomical and functional findings. Int J Oral Maxillofac Surg. 2001 Apr;30(2):123-9. doi: 10.1054/ijom.2000.0001.

  PMID: 11405447 BACKGROUND

• Turvey TA, Hall DJ, Warren DW. Alterations in nasal airway resistance following superior repositioning of the maxilla. Am J Orthod. 1984 Feb;85(2):109-14. doi: 10.1016/0002-9416(84)90002-2.

  PMID: 6594051 BACKGROUND

MeSH Terms

Conditions

Maxillofacial Abnormalities

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD,DDS

Model Details: double blind

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: January 15, 2021
• Primary Completion: August 15, 2021
• Study Completion: May 15, 2022
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)