NCT01871623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 7, 2013

Status Verified

March 1, 2013

Enrollment Period

2.9 years

First QC Date

May 23, 2013

Last Update Submit

June 3, 2013

Conditions

Cleft Lip and PalateLe Fort

Keywords

Cleft lip and palateCone-Beam Computed TomographyLe Fort I OsteotomySegmental OsteotomyStability

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Presence of pathological change of cleft-adjacent teeth

    immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment

Study Arms (2)

Segmental Le Fort I Osteotomy

EXPERIMENTAL

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

One-piece Le Fort I Osteotomy

ACTIVE COMPARATOR

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

Interventions

Segmental Le Fort I osteotomyPROCEDURE

comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy

Also known as: Segmental maxillary osteotomy, Maxillary Segmental osteotomy
Segmental Le Fort I Osteotomy
One-piece Le Fort I OsteotomyPROCEDURE

conventional approach

Also known as: Le Fort I Osteotomy, Le Fort 1 Osteotomy
One-piece Le Fort I Osteotomy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Association with craniofacial anomalies
  • Patient without complete 3D imaging records including CBCT scans and digital dental models

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Craniofacial Center

Taipei / Taoyuan, Taiwan

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Yu Fang Liao, Ph.D.

    Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa

    STUDY DIRECTOR

Central Study Contacts

Yu Ting Chiu, D.D.S., MS.

CONTACT

03-3196200tina1979@adm.cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 7, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2016

Study Completion

December 1, 2016

Last Updated

June 7, 2013

Record last verified: 2013-03

Locations

TW(1)