Clinical trial NCT01871623: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip and Palate
Le Fort
Keywords: Cleft lip and palate
Cone-Beam Computed Tomography
Le Fort I Osteotomy
Segmental Osteotomy
Stability
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: stability and relapse rate of surgical movement
timeFrame: 6 months after surgery & 1-2 years till the completion of the treatment
Secondary outcomes:
measure: Presence of pathological change of cleft-adjacent teeth
timeFrame: immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment
Other outcomes:
Locations:
city: Taipei / Taoyuan
country: Taiwan
facility: Chang Gung Craniofacial Center
Study officials:
affiliation: Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa
name: Yu Fang Liao, Ph.D.
role: STUDY_DIRECTOR
References: