An interventional study of Conventional and Subspinal in Maxillofacial Abnormalities, sponsored by TC Erciyes University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment
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.
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.
21 studies on the registry are indexed under Maxillofacial Abnormalities; 2 are open to participants now.
This study's enrollment of 47 is close to the median of 49 across 10 interventional studies indexed under Maxillofacial Abnormalities.
Browse Maxillofacial Abnormalities studies →TC Erciyes University is the lead sponsor of 349 studies on the registry; 74 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Le Fort I osteotomy performed with conventional Le Fort
Also known as: Group II
Osteotomy was performed in the subspinal Le Fort I group that is described by Mommaerts
Also known as: Group I
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.
Time frame: 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.
Time frame: up to six months
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
Time frame: up to six months
Plan to share: No
Ran from Jan 2021 to primary completion in Aug 2021, 7 months.
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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