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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01871623
• Other study ID #: 101-4416A3
• Status: Recruiting
• Phase: N/A
• First received: May 23, 2013
• Last updated: June 3, 2013
• Start date: April 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2013
• Source: Chang Gung Memorial Hospital
• Contact: Yu Ting Chiu, D.D.S., MS.
• Phone: 03-3196200
• Email: tina1979[@]adm.cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 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

Intervention

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
• One-piece Le Fort I Osteotomy
conventional approach

Locations

Country	Name	City	State
Taiwan	Chang Gung Craniofacial Center	Taipei / Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes