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

Primary Purpose

Cleft Lip and Palate, Le Fort

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Segmental Le Fort I osteotomy
One-piece Le Fort I Osteotomy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Cleft lip and palate, Cone-Beam Computed Tomography, Le Fort I Osteotomy, Segmental Osteotomy, Stability

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Craniofacial CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Segmental Le Fort I Osteotomy

One-piece Le Fort I Osteotomy

Arm Description

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.

For patients having ideal bone graft result over cleft site, traditional One-piece Le Fort I Osteotomy will be performed.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Presence of pathological change of cleft-adjacent teeth
record any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth

Full Information

First Posted
May 23, 2013
Last Updated
June 3, 2013
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01871623
Brief Title
One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy
Official Title
Stability of One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy: A Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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 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 Skeletal angular measurement change on mid-sagittal plane from (T2 to T1) and (T3 to T2) Dental change measured from digital maxillary cast in transverse direction from (T2 to T1) and (T3 to T2) Facial Height / Facial Proportion changes from (T2 to T1) and (T3 to T2) Alveolar cleft width changes from (T2 to T1) and (T3 to T2)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate, Le Fort
Keywords
Cleft lip and palate, Cone-Beam Computed Tomography, Le Fort I Osteotomy, Segmental Osteotomy, Stability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Segmental Le Fort I Osteotomy
Arm Type
Experimental
Arm Description
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.
Arm Title
One-piece Le Fort I Osteotomy
Arm Type
Active Comparator
Arm Description
For patients having ideal bone graft result over cleft site, traditional One-piece Le Fort I Osteotomy will be performed.
Intervention Type
Procedure
Intervention Name(s)
Segmental Le Fort I osteotomy
Other Intervention Name(s)
Segmental maxillary osteotomy, Maxillary Segmental osteotomy
Intervention Description
comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy
Intervention Type
Procedure
Intervention Name(s)
One-piece Le Fort I Osteotomy
Other Intervention Name(s)
Le Fort I Osteotomy, Le Fort 1 Osteotomy
Intervention Description
conventional approach
Primary Outcome Measure Information:
Title
stability and relapse rate of surgical movement
Description
to compare the stability and relapse rate in vertical, horizontal and transverse among two kinds of different surgical techniuques
Time Frame
6 months after surgery & 1-2 years till the completion of the treatment
Secondary Outcome Measure Information:
Title
Presence of pathological change of cleft-adjacent teeth
Description
record any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth
Time Frame
immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cleft lip/palate patients Non growing Taiwanese adults, at least 18 years old for men and 16 years old for women Patients with midface retrusion and malocclusion that will need Le Fort I osteotomy Rigid fixation with bone plates Patients who signs the informed consent form Exclusion Criteria: Association with craniofacial anomalies Patient without complete 3D imaging records including CBCT scans and digital dental models
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yu Ting Chiu, D.D.S., MS.
Phone
03-3196200
Ext
3500
Email
tina1979@adm.cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Fang Liao, Ph.D.
Organizational Affiliation
Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Craniofacial Center
City
Taipei / Taoyuan
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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