跳至主要内容
临床试验/NCT03511989
NCT03511989招募中不适用

Transverse Maxillary Expansion With a Segmental Le Fort I Osteotomy or Surgically Assisted Rapid Maxillary Expansion (SARME)

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
90
试验地点
1
主要终点
Skeletal relapse

研究概览

简要总结

To assess transverse dental and skeletal expansion and stability after SLFIO with no fixation of the palatal vault compared to stabilization of the palatal vault with an autogenous bone block graft or fixation of the palatal osteotomy site with a biodegradable plate.

To assess transverse maxillary dental and skeletal expansion and stability after SARME with a TB distraction appliance compared to a BB distraction appliance.

详细描述

Background: Surgical correction of transverse maxillary hypoplasia, in adolescents and adults is considered the least stable orthognathic procedure. Different surgical techniques have been advocated to improve the transverse stability. However, the pattern of transverse dental and skeletal expansion and long-term stability after segmental Le Fort I osteotomy (SLFIO) and surgically assisted rapid maxillary expansion (SARME) have never been compared systematically with different fixation techniques or distraction appliances.

Purpose: Test the H0-hypothesis of no difference in transverse stability after SLFIO without fixation of the palatal vault compared to stabilizing with either a bone block graft or a biodegradable plate. Moreover, test the H0-hypothesis of no difference in transverse maxillary dental and skeletal expansion and stability after SARME with either a tooth-borne (TB) or a bone-borne (BB) distraction appliance.

Method: 60 patients scheduled for SLFIO are included in a randomized clinical trial and allocated into 3 groups; I) stabilization of the palatal vault with a bone block graft, II) fixation of the palatal vault with a biodegradable plate and III) no fixation of the palatal vault. Moreover, 30 patients undergoing SARME are randomly allocated to either a TB or a BB distraction appliance. Transverse expansion and stability is assessed by clinical and radiographic measurements evaluating differences between dental and skeletal expansion, the pattern of skeletal expansion and the long-term stability.

Primary impact goal: Long-term transverse maxillary stability after SLFIO and SARME.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Mature non-syndromic patients scheduled for transverse expansion of the maxilla

排除标准

  • •Previous orthognathic surgery involving the maxilla Congenital maxillofacial deformities

研究组 & 干预措施

Bone Borne distractor

Active Comparator

The device being investigated, Boneborne distraction appliance

干预措施: Bone borne distractor (Device)

Tooth borne distractor

Other

The control device Toothborne distraction appliance

干预措施: Tooth borne distractor (Device)

Segmental LF1 osteotomy group 1

No Intervention

Control Group, no stabilization of palatal vault

Segmental LF1 osteotomy group 2

Active Comparator

Testgroup, biodegradable plate at osteotomy site in palate

干预措施: Segmental LF1 Osteotomy group 1 (Procedure)

Segmental LF1 osteotomy group 2

Active Comparator

Testgroup, biodegradable plate at osteotomy site in palate

干预措施: Segmental LF1 Osteotomy group 3 (Procedure)

Segmental LF1 osteotomy group 3

Active Comparator

Testgroup, autologous bonegraft at palatal osteotomy site

干预措施: Segmental LF1 Osteotomy group 1 (Procedure)

Segmental LF1 osteotomy group 3

Active Comparator

Testgroup, autologous bonegraft at palatal osteotomy site

干预措施: Segmental LF1 Osteotomy group 2 (Procedure)

结局指标

主要结局

Skeletal relapse

时间窗: 2 years

Relapse in milimeters

次要结局

  • Dental relapse(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tue Lindberg Blæhr

Consultant Oral and Maxillofacial Surgery

Aalborg University Hospital

研究点 (1)

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