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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01871623
First received: May 23, 2013
Last updated: June 3, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Cleft Lip and Palate
Le Fort
Procedure: Segmental Le Fort I osteotomy
Procedure: One-piece Le Fort I Osteotomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stability of One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy: A Prospective Study

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • stability and relapse rate of surgical movement [ Time Frame: 6 months after surgery & 1-2 years till the completion of the treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment ] [ Designated as safety issue: Yes ]
    record any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth


Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
Other Names:
  • Segmental maxillary osteotomy
  • Maxillary Segmental osteotomy
Active Comparator: 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.
Procedure: One-piece Le Fort I Osteotomy
conventional approach
Other Names:
  • Le Fort I Osteotomy
  • Le Fort 1 Osteotomy

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)
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871623

Contacts
Contact: Yu Ting Chiu, D.D.S., MS. 03-3196200 ext 3500 tina1979@adm.cgmh.org.tw

Locations
Taiwan
Chang Gung Craniofacial Center Recruiting
Taipei / Taoyuan, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Study Director: Yu Fang Liao, Ph.D. Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa
  More Information

No publications provided

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01871623     History of Changes
Other Study ID Numbers: 101-4416A3
Study First Received: May 23, 2013
Last Updated: June 3, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Cleft lip and palate
Cone-Beam Computed Tomography
Le Fort I Osteotomy
Segmental Osteotomy
Stability

Additional relevant MeSH terms:
Cleft Lip
Lip Diseases
Mouth Diseases
Stomatognathic Diseases
Mouth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 26, 2014