One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy

Stability of One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy: A Prospective Study

Le Fort I osteotomy is often used in orthognathic surgery for patients to solve midface retrusion. It is known that post-surgical stability of Le Fort I osteotomy can be influenced by single jaw or bimaxillary procedures, fixation techniques or interpositional grafting. In patients with cleft lip and palate, the postoperative instability of Le Fort I osteotomy can be even worse due to scar tissue resulted from palate surgery. Segmental LeFort I osteotomy is another useful surgical modifications that can be easily done through the alveolar cleft. It is performed to allow the correction of differences in the occlusal planes, correction of transverse discrepancy or to facilitate an optimal occlusion. The most important benefits is that the alveolar cleft in patients who have not had alveolar bone graft surgery or failed to have successful result can be narrow down or even closed by approximation of two separating alveolar segments. However, there are limited previous studies comparing the stability of segmental versus one-piece Le Fort I osteotomy especially in patients with cleft. It is our aim to investigate whether one-piece Le Fort I osteotomy or segmental Le Fort I osteotomy can provide a better stability after surgery.

Study Overview

• Status: Unknown
• Conditions: Cleft Lip and Palate; Le Fort
• Intervention / Treatment: Procedure: Segmental Le Fort I osteotomy; Procedure: One-piece Le Fort I Osteotomy

Detailed Description

Measurements Skeletal movement

1. Skeletal Surgical movement from T2 to T1

   • positional change of landmarks in vertical from constructed Frankfurt plane
   • positional change of landmarks in horizontal plane in relative to constructed coronal plane through Sella point

2. Post-Surgical skeletal movement (Stability) from T3 to T2

   • positional change of landmarks in vertical from constructed Frankfurt plane
   • positional change of landmarks in horizontal plane in relative to constructed coronal plane through Sella point
3. Skeletal angular measurement change on mid-sagittal plane from (T2 to T1) and (T3 to T2)
4. Dental change measured from digital maxillary cast in transverse direction from (T2 to T1) and (T3 to T2)
5. Facial Height / Facial Proportion changes from (T2 to T1) and (T3 to T2)
6. Alveolar cleft width changes from (T2 to T1) and (T3 to T2)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei / Taoyuan, Taiwan
    • Recruiting
    • Chang Gung Craniofacial Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Cleft lip/palate patients
2. Non growing Taiwanese adults, at least 18 years old for men and 16 years old for women
3. Patients with midface retrusion and malocclusion that will need Le Fort I osteotomy
4. Rigid fixation with bone plates
5. Patients who signs the informed consent form

Exclusion Criteria:

1. Association with craniofacial anomalies
2. Patient without complete 3D imaging records including CBCT scans and digital dental models

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Segmental Le Fort I Osteotomy; For some cases that bone filling over cleft site is not good enough for tooth movement, it is possible that we put them into this group which means by using Segmental Le Fort I Osteotomy to approximate two dental alveolar segments.	Procedure: Segmental Le Fort I osteotomy; comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy; Other Names: Segmental maxillary osteotomy; Maxillary Segmental osteotomy
ACTIVE_COMPARATOR: One-piece Le Fort I Osteotomy; For patients having ideal bone graft result over cleft site, traditional One-piece Le Fort I Osteotomy will be performed.	Procedure: One-piece Le Fort I Osteotomy; conventional approach; Other Names: Le Fort I Osteotomy; Le Fort 1 Osteotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stability and relapse rate of surgical movement	to compare the stability and relapse rate in vertical, horizontal and transverse among two kinds of different surgical techniuques	6 months after surgery & 1-2 years till the completion of the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of pathological change of cleft-adjacent teeth	record any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth	immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Yu Fang Liao, Ph.D., Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ANTICIPATED): March 1, 2016
• Study Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: June 3, 2013
• First Posted (ESTIMATE): June 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 7, 2013
• Last Update Submitted That Met QC Criteria: June 3, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Cone-Beam Computed Tomography; Stability; Cleft lip and palate; Le Fort I Osteotomy; Segmental Osteotomy
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 101-4416A3