Evaluation of the Effects of Subspinal Le Fort and Conventional Le Fort I Osteotomy on Nasolabial Soft Tissues
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- TC Erciyes University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- nasal base width
Study Overview
Brief Summary
Following surgical operations, patients have aesthetic expectations as well as functional ones. To minimize undesirable aesthetic results after surgery and to increase the effectiveness of the surgery, the surgical method used for maximum aesthetic results is important, both in pre-operative planning and during surgery. In addition, effective control of bleeding and subsequent edema during surgical operations is a high priority for clinical research in surgical applications. Controlling edema and soft tissue damage improves the quality of life of patients after surgery, reduces morbidity and provides greater comfort, and also allows patients to recover quickly and return to their daily activities sooner. Although the developing edema is temporary, it is known to cause serious depressive disorders in some patients. Minimally invasive approach and maximum aesthetic results during surgery are affected by the surgical technique. This study will contribute to the literature by comparing subspinal Le Fort osteotomy with conventional osteotomy.
Detailed Description
In this study, the effect of the type of osteotomy used in the osteotomy phase of orthognathic surgery on the changing parameters (bleeding, edema, soft tissue changes, etc.) during and after surgery will be investigated. While comparing conventional Le Fort I osteotomy with subspinal Le Fort I osteotomy, the advantages and disadvantages of the surgical techniques in the intraoperative and postoperative periods will be determined. This will be the first study to evaluate nasolabial soft tissue changes after subspinal Le Fort osteotomy and to subjectively and objectively compare it with conventional osteotomy performed without v-y closure and cinch sutures, and to evaluate the effect of both methods on postoperative edema. Subspinal Le Fort osteotomy is thought to minimize the widening of the nasal floor. This study has a unique value because it not only evaluates the soft tissue effectiveness of Le Fort osteotomy methods but also provides a three-dimensional comparison of these variables and a subjective explanation. Simultaneously comparing many parameters during and after surgery, and thanks to the results obtained from this study, it will contribute to increasing both the in-operative comfort of oral surgeons and the post-operative comfort of patients. the result of this study, subspinal Le Fort osteotomy will reduce bleeding by reducing dissection during surgery, minimize damage to soft tissues, and prevent unwanted soft tissue changes after surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
double blind
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •without systemic disease,
- •without any drug allergy,
- •and without a history of NSAID use in the week before the operation,
- •patients in both groups did not apply alar cinch suture, V-Y closure, or ANS reduction
Exclusion Criteria
- •history of cleft lip palate and rhinoplasty
Arms & Interventions
CLFI (conventional Le fort I osteotomy )
CLFI was performed as usual Bell WH methods . The maxillary osteotomy was performed from nasal buttress to pterygomaxiller junction by piezosurgery in both groups. Bilateral pterygoid splits were performed with a chisel. After down fracture, bony interferences were removed and maxilla was fixed with miniplates and screws in its new position. ANS repositioning or recounturing, alar cinch suture and V-Y closure were not applied at all.
Intervention: conventional le fort I osteotomy type (Procedure)
SLFI (Subspinal Le Fort I Osteotomy )
SLFI was performed, preventing the pre-existing nasal muscle origins. V-shaped osteotomy at the base of the ANS through a vestibular incision was existed in SLFI. ANS was never exposed to preserve the attachments and periost. Then, the nasal septum and lateral nasal walls were separated by appropriate osteotomes. After this osteotomy, the ANS was separated from the maxilla so that the ANS remains in its former position, hence it is not affected by maxillary movements. To be perpetuated the effectiveness of myrtiformis muscle, that muscle was remained in its former position
Intervention: subspinal le fort I osteotomy type (Procedure)
Outcomes
Primary Outcomes
nasal base width
Time Frame: up to six months
Nasal base width refers to the transverse distance between the most lateral points of the alar bases, reflecting the overall width of the nasal foundation at the level of the nostrils. Measurement: It is measured as the linear distance between the right and left alare (al-al) points on frontal view photographs or 3D images, typically using digital calipers or imaging software.
alar base width
Time Frame: up to six months
Alar base width is defined as the horizontal distance between the most lateral insertion points of the alar bases where the nostrils meet the cheek. Measurement: It is measured as the linear distance between the right and left alare (al-al) landmarks on frontal photographs or 3D stereophotogrammetric images, using calibrated digital software or calipers.
upper lip length
Time Frame: up to six months
Upper lip length is defined as the vertical distance between the subnasale and the labiale superius, representing the height of the upper lip in the midline. Measurement: It is measured as the linear distance from subnasale (Sn) to labiale superius (Ls) on profile or frontal images using digital measurement software or calipers.
nasolabial angle
Time Frame: up to six monts
Nasolabial angle is the angle formed between the columella and the upper lip, reflecting the anteroposterior position and rotation of the nasal tip relative to the upper lip. Measurement: It is measured as the angle between a line drawn from subnasale to columella (columellar tangent) and a line from subnasale to labiale superius on lateral profile images or cephalometric analysis.
columellalobular angle
Time Frame: up to six months
Columellalobular angle is the angle formed between the columella and the infratip lobule, reflecting the contour and transition between the nasal tip and columella. Measurement: It is measured as the angle between the columellar line and the infratip lobular line on lateral profile photographs or 3D images using digital analysis software.
nasal tip angle
Time Frame: up to six months
Nasal tip angle is defined as the angle formed at the pronasale by the intersection of lines extending from the nasion to the pronasale and from the pronasale to the columella, reflecting nasal tip projection and rotation. Measurement: It is measured on lateral profile images as the angle between the nasion-pronasale line and the pronasale-columella line using digital software or cephalometric analysis tools.
nostril width
Time Frame: up to six months
Nostril width is defined as the maximum horizontal distance across an individual nostril, reflecting the transverse dimension of the nostril aperture. Measurement: It is measured as the widest distance between the medial and lateral borders of the nostril on basal view photographs or 3D images using calibrated digital software or calipers.
Secondary Outcomes
- edema(up to six months)
- rhinoplasty outcome evaluation (roe scale)(up to six months)
Investigators
Selin Celebi
specialist physician, DDS,MDS
TC Erciyes University