Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction: A Randomized Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Percentage fill
研究概览
简要总结
Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation.
Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure.
To Augment the alveolar defect in three-dimensions, accurate assessment of alveolar cleft is essential, virtual surgical planning can be combined with 3D printing to re-create the defect virtually. Based of virtually created defect a patient specific mold can be designed. Printed mold will be used as a medium for adding particulate autogenous graft mixed with fibrin glue creating a plug with the precise shape of the alveolar cleft, the fibrin glue will assist in forming the plug as well as acting as a scaffold for migrating fibroblasts as well as a hemostatic barrier, stimulates mesenchymal cell, induces and promotes angiogenesis, and also initiates early osteogenesis.
详细描述
-The aim of this study is to describe an auxiliary surgical techniques in alveolar cleft reconstruction and evaluate volume of the bone.
Research question:
Does the use of patient specific autogenous plug yield better 3D volume than conventional autogenous graft.
Statement of the problem:
Cleft patients need a precise treatment regimen, which makes the treatment challenging. Multidisciplinary approach is required and collaboration of multiple specialties is needed; OMFS, orthodontists, plastic surgeons, speech therapist and pedodontists. One of the most crucial steps in treatment of cleft patients is the repair of the alveolar defect to achieve stability of the arch, provide room for canine and lateral incisor to erupt, maintain periodontal health of adjacent teeth, restore continuity of piriform rim, support the ala of the nose to allow for better facial appearance, closure of oronasal fistula to decrease chance URT infections and allow for better hygiene and speech., It is essential to understand and evaluate the geometry and size of the defect, to avoid improper grafting of the defect, enhance the evaluation of the alveolar defect preoperatively, and the graft integration postoperatively and to allow precise repair of the alveolar defect. (Watted et al., 2020) (Stolarz et al.,2022) Each alveolar cleft has a unique shape in mesio-distally, antro-posteriorly, which creates a challenge to fill the defect in all dimensions. The precise assessment of the cleft geometry can be determined by computed tomography (CT), or cone- beam CT (CBCT) which allows simultaneous alveolar cleft assessment, planning and volume measurement.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Patients with unilateral alveolar clefts who completed pre-operative expansion.
- •Patients with good oral hygiene.
- •Patients free from any medical condition that might compromise the healing process.
- •Both males and females will be included in trail.
- •Age range from 7 years to 12 years.
排除标准
- •Unmotivated/uncooperative patients and/or parents.
- •Patients who previously underwent unsuccessful treatment trails.
- •Patients with insufficient ridge expansion.
研究组 & 干预措施
autogenous bone plug
干预措施: autogenous bone plug (Other)
control
干预措施: regular autogenous bone grafting (Other)
结局指标
主要结局
Percentage fill
时间窗: 6 months
次要结局
- bone density(6 months)