Skip to main content
OpenTrials
Completed

NCT Number: NCT07549659

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Maxillofacial Deformity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Edema Maxillo-facial Surgery Maxillofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erciyes University

Kayseri, Talas, 38280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • history of cleft lip palate and rhinoplasty

Treatment and study plan

conventional le fort I osteotomy type

Procedure

that performed with conventional Le Fort I

subspinal le fort I osteotomy type

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  1. edema

    Time frame: up to six months

    Also, the images were used to compare postoperative edema between the groups. To determine even the minutest difference between the two groups, three-dimensional (3D) images were taken at preoperatively and postoperatively on 1, 3, 7, 14, 21, 30 day, 3 month and 6 month after surgery at maximum intercuspidation when the lips were free and the eyes were open

  2. rhinoplasty outcome evaluation (roe scale)

    Time frame: up to six months

    The Rhinoplasty Outcome Evaluation is a patient-reported outcome measure designed to assess satisfaction with nasal appearance and function following rhinoplasty.

    Measurement:

    It consists of 6 questions, each scored from 0 (most negative) to 4 (most positive); the total score is summed, divided by the maximum possible score (24), and multiplied by 100 to yield a percentage score ranging from 0 to 100, where higher scores indicate greater patient satisfaction.

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Evaluation of the Effects of Subspinal Le Fort and Conventional Le Fort I Osteotomy on Nasolabial Soft Tissues

Important dates

Study start
2021
Primary completion
2021
Study completion
2024
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.