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

Cleft Lip and Palate Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate
• Le Fort

• NCT number: NCT01871623
• Study type: Interventional
• Source: Chang Gung Memorial Hospital
• Contact: Yu Ting Chiu, D.D.S., MS.
• Phone: 03-3196200
• Email: tina1979@adm.cgmh.org.tw
• Status: Recruiting
• Phase: N/A
• Start date: April 2013
• Completion date: December 2016