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
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
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
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
NCT ID
NCT01871623
First Posted
May 23, 2013
Last Updated
June 3, 2013
Sponsor
Chang Gung Memorial Hospital
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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