a Comparative Analysis of Subspinal and Conventional Le Fort I Osteotomy on Nasolabial Soft Tissues

NCT07549659 | Completed

• 2 other identifiers: 2021/048TDH-2021-11020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillofacial Deformity; Maxillofacial Abnormalities; Maxillo-facial Surgery

Keywords

subspinal osteotomy; edema; nasolabial changes

Outcome Measures

Primary Outcomes (7)

• nasal base width

  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.

  up to six months

• alar base width

  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.

  up to six months

• upper lip length

  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.

  up to six months

• nasolabial angle

  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.

  up to six monts

• columellalobular angle

  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.

  up to six months

• nasal tip angle

  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.

  up to six months

• nostril width

  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.

  up to six months

Secondary Outcomes (2)

• edema

  up to six months

• rhinoplasty outcome evaluation (roe scale)

  up to six months

Study Arms (2)

CLFI (conventional Le fort I osteotomy )

ACTIVE COMPARATOR

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.

Procedure: conventional le fort I osteotomy type

SLFI (Subspinal Le Fort I Osteotomy )

EXPERIMENTAL

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

Procedure: subspinal le fort I osteotomy type

Interventions

conventional le fort I osteotomy type PROCEDURE

that performed with conventional Le Fort I

CLFI (conventional Le fort I osteotomy )

subspinal le fort I osteotomy type PROCEDURE

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

SLFI (Subspinal Le Fort I Osteotomy )

Eligibility Criteria

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

You may qualify if:

• ASA I,
• 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

You may not qualify if:

• history of cleft lip palate and rhinoplasty

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, Talas, 38280, Turkey (Türkiye)

Location

Related Publications (6)

• Mommaerts MY, Abeloos JVS, De Clercq CAS. Comparison of two different techniques to control nasal base width and tip projection in Le Fort I-type osteotomies. J Craniomaxillofac Surg 1994;22:41.

  RESULT

• Mansour S, Burstone C, Legan H. An evaluation of soft-tissue changes resulting from Le Fort I maxillary surgery. Am J Orthod 1983;84:37-47.

  RESULT

• Yamashsita Y, Iwai T, Honda K, Fujita K, Imai H, Takasu H, Omura S, Hirota M, Mitsudo K. Effectiveness of subspinal Le Fort I osteotomy in preventing postoperative nasal deformation. Journal of Plastic, Reconstructive & Aesthetic Surgery 2020;73:1326-30.

  RESULT

• Davidson E, Kumar AR. A preliminary three-dimensional analysis of nasal aesthetics following Le Fort I advancement in patients with cleft lip and palate. Journal of Craniofacial Surgery 2015;26:e629-33.

  RESULT

• Moragas JSM, Van Cauteren W, Mommaerts MY. A systematic review on soft-to-hard tissue ratios in orthognathic surgery part I: maxillary repositioning osteotomy. Journal of Cranio-Maxillofacial Surgery 2014;42:1341-51.

  RESULT

• Miloro M, Ghali GE, Larsen PE, Waite PD. Peterson's principles of oral and maxillofacial surgery. vol. 1. Springer; 2004.

  RESULT

MeSH Terms

Conditions

Maxillofacial Abnormalities; Edema

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Stomatognathic System Abnormalities; Stomatognathic Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: specialist physician, DDS,MDS

Model Details: double blind

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 24, 2026
• Study Start: January 15, 2021
• Primary Completion: December 25, 2021
• Study Completion: June 15, 2024
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

TU (1)