Clinical Trial: One-Piece Le Fort I Osteotomy Versus Segmental Le Fort I Osteotomy

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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)

Sponsor: Chang Gung Memorial Hospital

Current Primary Outcome: stability and relapse rate of surgical movement [ Time Frame: 6 months after surgery & 1-2 years till the completion of the treatment ]

to compare the stability and relapse rate in vertical, horizontal and transverse among two kinds of different surgical techniuques


Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

record any periodontal breakdown or periapical radiolucency of cleft-adjacent teeth


Original Secondary Outcome: Same as current

Information By: Chang Gung Memorial Hospital

Dates:
Date Received: May 23, 2013
Date Started: April 2013
Date Completion: December 2016
Last Updated: June 3, 2013
Last Verified: March 2013