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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.
Measurements Skeletal movement
Skeletal Surgical movement from T2 to T1
Post-Surgical skeletal movement (Stability) from T3 to T2
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Segmental Le Fort I osteotomy | Procedure | comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of pathological change of cleft-adjacent teeth | record any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth | immediate after surgery, 6 months after surgery & 2 years till the completion of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Ting Chiu, D.D.S., MS. | Contact | 03-3196200 | 3500 | tina1979@adm.cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yu Fang Liao, Ph.D. | Chang Gung Craniofacial Center , Chang Gung Memorial Hospial , Taoyuan , Taiwa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Craniofacial Center | Recruiting | Taipei / Taoyuan | Taiwan |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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| One-piece Le Fort I Osteotomy | Procedure | conventional approach |
|
|
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |