The Difference in the Surgical Outcome of Unilateral Cleft Lip and Palate Between Patients With and Without Pre-Alveolar Bone Graft Orthodontic Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 24
- 主要终点
- Pre-orthodontic alveolar bone defect
研究概览
简要总结
Alveolar bone grafting (ABG) is an essential part of the surgical management of cleft lip and palate patients. This procedure could obliterate oronasal fistula, stabilize dental arch, offer bone matrix for adjacent teeth eruption. Moreover, by obliterating oronasal fistula, we stop the chronic irritation of nasal mucosa by oral content. Hence, the symptoms of rhinorrhea or nasal obstruction could be improved. This dental arch defect could predispose further dental arch medial collapse. Without alveolar bone grafting the dental arch is not stable, dental movement during orthodontic treatment is limited and dental arch expansion is not possible.
Previous to operation, the patient suffered from dental crowding and dental inclination toward to the cleft. This produces a difficult dental hygiene and predispose to dental caries and gingivitis. Pre-operative orthodontics treatment is advised in many centers. By aligned the teeth previous to surgery, with a better dental hygiene, we purpose that the infection rate will be reduced and success rate will be better.
The Purpose of this study is to determine whether pre-operative orthopedic treatment will affect secondary alveolar bone grafting outcome and to assess the nasal change after alveolar bone graft.
详细描述
Overall goals of study:
The goals of this study are to determine whether pre-operative orthodontic treatment will affect secondary alveolar bone grafting outcome
Importance of alveolar bone grafting Alveolar bone cleft is present in the majority of patients with cleft lip and palate. This bone cleft destabilizes the maxillary arch and predisposes it to medial collapse. Teeth will not erupt in this region of alveolar bone defect. Permanent stabilization of the maxillary segments into a functional dental arch form is achieved by reconstruction of alveolar with bone grafts. The goals of alveolar bone grafting are to maintain normal occlusion and to provide a matrix for the continued eruption of permanent teeth in this region. Moreover, future maxillary expansion cannot be done unless repair of the alveolar cleft is coordinated with the desired orthodontic movement.
Timing of alveolar bone grafting Maxillary growth and dental age are the predominant considerations in determining the timing of alveolar reconstruction. Maxillary growth is completed near the age of eight years old, whereas the maxillary canine does not erupt before the age of ten.Therefore, to minimize growth disturbance to the maxilla, reconstruction should be performed after the growth is completed.It has been widely agreed that the timing of alveolar grafting should be around the stage of mixed dentition . The bone grafting should be completed at approximately nine years of age when the bulk of the alveolar bone growth is completed and the incisors are erupted, while the lateral incisors and canines are starting to erupt into alveolar cleft region
Diagnosis Radiographic studies, including panoramic radiographs, selected periapical films, Cephalographic films and recently CT scan are integral parts for diagnosis and evaluation. They provide important assessments of the pre-operative dentition in the vicinity of the cleft, the dimensions and structures of cleft itself as well as postoperative condition of the bone bridge after alveolar bone grafting.The CT scan offers more detailed pre-operative and post-operative bone structures with less distortion. Additionally, CT scan also provide: 1. Detailed information about the depth and volume of bone deposited in the cleft, 2. More consistent in showing bone trabeculation, 3. Detailed position of erupting teeth relative to the bone graft, 4. More detailed bone and teeth anatomy for clinical orthodontics decisions. In addition, the CT scan could offer 3D lineal measurements and volumetric analysis . Arai et al. developed a novel cone-bean CT (CBCT) or Ortho CT which has important characteristics such as lowered radiation dose and the ability to produce higher resolution compared to conventional spiral CT. Several reports have indicated that it is clinical useful for the 3D imaging diagnosis in the maxillofacial region.
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
- None
入排标准
- 年龄范围
- 8 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral complete cleft lip patients
- •Alveolar bone cleft diagnosed with conventional radiographic study
- •Patients at the stage of mixed dentition.
- •Informed consent signed by the parents or custodians.
排除标准
- •Presentation of other craniofacial anomalies.
- •Parents or custodians who do not agreed to this procedure.
结局指标
主要结局
Pre-orthodontic alveolar bone defect
时间窗: Before surgical and orthodontic treatment, A expected average of 6 months before surgery
CT scan, measurement of alveolar bone cleft defect volume
Pre-surgical alveolar bone defect
时间窗: Before surgical treatment (alveolar bone cleft), a expected average of 6 months of orthodontic treatment
CT scan, measurement of alveolar bone cleft defect volume
Alveolar bone graft survival
时间窗: A expected average of 6 months after surgery
CT scan, measurement of volume of bone graft filling the alveolar bone cleft
次要结局
- Infection rate(up to 6 months)
