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

NCT ID: NCT01871623

Last Updated: 2013-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-12-31

Brief Summary

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.

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)

Conditions

Cleft Lip and Palate; Le Fort

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Segmental Le Fort I osteotomy

Intervention Type: PROCEDURE

comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy

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.

Group Type: ACTIVE_COMPARATOR

One-piece Le Fort I Osteotomy

Intervention Type: PROCEDURE

conventional approach

Interventions

Segmental Le Fort I osteotomy

comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy

Intervention Type: PROCEDURE

One-piece Le Fort I Osteotomy

conventional approach

Intervention Type: PROCEDURE

Other Intervention Names

Segmental maxillary osteotomy; Maxillary Segmental osteotomy; Le Fort I Osteotomy; Le Fort 1 Osteotomy

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu Fang Liao, Ph.D.

Role: STUDY_DIRECTOR

Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa

Locations

Chang Gung Craniofacial Center

Taipei / Taoyuan, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu Ting Chiu, D.D.S., MS.

Role: CONTACT

tina1979@adm.cgmh.org.tw

03-3196200 ext. 3500

Other Identifiers

101-4416A3

Identifier Type: -

Identifier Source: org_study_id