Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06281197
Other study ID # 2021/48
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2021
Est. completion date May 15, 2022

Study information

Verified date February 2024
Source TC Erciyes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date May 15, 2022
Est. primary completion date August 15, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Conventional
Le Fort I osteotomy performed with conventional Le Fort
Subspinal
Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts

Locations

Country Name City State
Turkey Selin Çelebi Kayseri Meligazi

Sponsors (1)

Lead Sponsor Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 nasal obstruction scale evaluation 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 up to six months
See also
  Status Clinical Trial Phase
Recruiting NCT06183853 - Evaluation of the Long-term Results of Extended Supra-basillary Genioplasty of the "Chin Wing" Type Without Bone Graft
Active, not recruiting NCT05713084 - Condylar Position Changes and TMJ Functions After BSSO Mandibular Setback, Low Medial Cut. N/A
Recruiting NCT04035928 - Digital Design for Maxillofacial Prosthetics N/A
Completed NCT01983436 - Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery N/A
Recruiting NCT05151042 - Digital Occlusal Wafer Versus Waferless Distal Segment Repositioning for BSSO in Skeletal Mandibular Deformities N/A
Recruiting NCT02595307 - Improving Informed Consent for Cleft Palate Repair N/A
Not yet recruiting NCT06263374 - Maxillofacial Rehabilitation Using Motor Imagery vs Sham After Orthognathic Surgery N/A
Withdrawn NCT04442009 - Superficial Cervical Plexus Block for Orthognathic Surgery N/A
Completed NCT04416386 - Vitamin C Level Effect in Orthognathic Surgery
Completed NCT01486069 - Mandibular Stability and Dentofacial Deformity N/A
Recruiting NCT05936476 - Impact of Maxillomandibular Deformities on Individuals' Nutritional Status
Completed NCT04813289 - Review of Anaesthetic Practice in Orthognathic Surgery
Completed NCT04895319 - Adherence to Computer-assisted Maxillofacial Reconstructions
Active, not recruiting NCT05271383 - Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
Completed NCT03357211 - Accuracy of Maxillary Repositioning During Orthognathic Surgery N/A
Recruiting NCT00285714 - 3D Imaging of Hard and Soft Tissue in Orthognathic Surgery N/A
Completed NCT06273189 - Ultrasonic Bone Scalpel in BSSO N/A
Completed NCT06454825 - Effects of Antiemetic Agents in Orthognathic Surgery Patients Phase 4