Lecturer of Oral and Maxillofacial Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- measuring the distance between the lesion and alveolar crest in both groups
研究概览
简要总结
Twenty patients with benign mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
The patients will be evaluated clinically to evaluate healing and radiographically using cone beam CT (CBCT) scan to identify bone healing, the extension and the volume of lesion six months later
详细描述
Purpose: This study aimed to compare the clinical and radiologic outcomes of the bone lid technique performed using a piezoelectric device versus the traditional technique in patients requiring excision of the mandibular bony lesions
Materials & Methods: Twenty patients with mandibular lesion will be included in this study. the patient will be divided randomly (10 patients each group). Group I the lesion will be treated using bone lid technique. Group II the lesion will be treated using the standard technique. The patients will be received, clinically and radiologically examined, and managed at the Oral and Maxillofacial surgery Department, Faculty of Dentistry, Tanta University.
Preoperative evaluation: The patients will be evaluated clinically and radiographically using Cone beam CT(CBCT) scan to identify the extension and the volume of lesion.
Surgical procedure: A full thickness flap will be elevated in both groups to achieve access to the bone above the lesion, in group I osteotomy of bone will be designed to extend beyond the actual extension of lesion in radiograph using piezoelectric device to secure a latter repositioning of the lid on a healthy stable bone. The osteotomy will be performed with an internal bevel angle to facilitate repositioning. The removed bone lid will be soaked in saline. After excision of the lesion, the bony lid will be repositioned to its original position and fixed to the bone with an absorbable suture.
In group II the bone will be removed buccally using surgical bur then the lesion is removed. Finally, the flap will be sutured in both groups.
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 (Participant)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 6 years
- •presence of bony lesion (cysts, benign tumors, odontoma) located in mandibular region,
- •the existence of a normal residual buccal cortical plate with the adequate thickness (≥1 mm) at least at the periphery of buccal cortical plate
排除标准
- •• patients taking medications that affect bone metabolism,
- •patients underwent head and neck radiotherapy
结局指标
主要结局
measuring the distance between the lesion and alveolar crest in both groups
时间窗: six months
making perpendicular line from alveolar crest on the occlusal plane and measuring the distance from alveolar crest to the lesion in (mm) using (Coronal view posterior, sagittal anterior) in CBCT.
density of bone calculated radiographically in both groups
时间窗: six months
CBCT to measure density (D1\> 1250 ,D2 850-1250,D3 350-850,D4 150-350) hounsfield
soft tissue healing evaluated clinically in both groups
时间窗: one week
adequate means closed or inadequate means open wound
infection evaluated clinically in both groups
时间窗: one week-one month
1 means mild,2 means moderate or3 means sever infection
cyst area calculation radiographically in both groups
时间窗: six months
using CBCT to measure the area in mm2
degree of pain evaluated clinically in both groups
时间窗: one-two weeks
using visual analogue scale:0 represent no pain and 10 represents the highest level of pain
次要结局
- inflammation clinically in both groups(one week)
- integration of buccal cortex radigraphically in both groups(six months)
研究者
mona samy sheta
Lecturer of Oral and Maxillofacial Surgery Department
Tanta University