Maxillofacial Abnormalities Clinical Trial
Official title:
Does Subspinal Le Fort I Osteotomy Affect the Nasal Airway Volume
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 |
Verified date | February 2024 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Selin Çelebi | Kayseri | Meligazi |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
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 all — Click here to view all references
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 |
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 |