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

Stability of One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy: A Prospective Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01871623
Enrollment
60
Registered
2013-06-07
Start date
2013-04-30
Completion date
2016-12-31
Last updated
2013-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip and Palate, Le Fort

Keywords

Cleft lip and palate, Cone-Beam Computed Tomography, Le Fort I Osteotomy, Segmental Osteotomy, Stability

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 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)

Interventions

PROCEDURESegmental Le Fort I osteotomy

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

PROCEDUREOne-piece Le Fort I Osteotomy

conventional approach

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
stability and relapse rate of surgical movement6 months after surgery & 1-2 years till the completion of the treatmentto compare the stability and relapse rate in vertical, horizontal and transverse among two kinds of different surgical techniuques

Secondary

MeasureTime frameDescription
Presence of pathological change of cleft-adjacent teethimmediate after surgery, 6 months after surgery & 2 years till the completion of the treatmentrecord any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth

Countries

Taiwan

Contacts

Primary ContactYu Ting Chiu, D.D.S., MS.
tina1979@adm.cgmh.org.tw03-3196200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026