EFFICACY OF TRANSMUCOSAL MINIPLEITE STABILIZATION TECHNIQUE VERSUS INTRA-ARCH WIRE STABILIZATION TECHNIQUE FOR FIXATION OF SAGITTAL & PARA-SAGITTAL TYPES OF PALATAL FRACTURES IN TERMS OF INTRA-ARCH MOLAR DISTANCE & MAXILLO-MANDIBULAR MOLAR RELATION
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Maxillo-Mandibular Molar Relation
研究概览
简要总结
The purpose of this study is to reduce uncertainity around decision making regarding use of transmucosal miniplate stabilization technique in place of intra-arch wire stabilization technique to get better outcomes. It will help establish future guidelines for sagittal and para-sagittal types of palatal fracture treatment Under general anasthesia wires will be passed between molars of both sides for palatal fracture reduction or fracture will be reduced by applying plate at fracture site
详细描述
Patients who present to a tertiary care oral and maxillofacial surgery department with sagittal or parasagittal palatal fractures will have their data prospectively gathered. Participants will be randomized to either the intra-arch wire stabilization group or the transmucosal miniplate stabilization group after providing their informed consent and undergoing eligibility screening.
Details of the Surgical Procedure
- Preoperative Assessment:
A thorough clinical examination that includes a palatal integrity assessment and an occlusal evaluation.
To verify the kind (sagittal or para-sagittal) and extent of a palatal fracture, radiological imaging (CT or 3D CBCT scans) will be used along with imprints of the mandible and maxilla for model analysis and preoperative anesthetic evaluation and preventative antibiotics. 2. Technique for Intra-Arch Wire Stabilization:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥16 years
- •Both gender
- •CT scan confirmation of a sagittal or para-sagittal palatal fracture
- •Dentate patients whose first molars are intact
排除标准
- •• Transverse or comminuted palatal fractures
- •Patients with edentulous teeth
- •Coagulopathies or serious systemic diseases
- •Patients who decline to follow up
结局指标
主要结局
Maxillo-Mandibular Molar Relation
时间窗: 4,8 and 12 weeks
The upper and lower first molars' occlusal alignment is evaluated both clinically, to classify them as normal, mildly malocclusion, or severely malocclusion. Molar relationships are compared to Angle's classification by visual clinical assessment. The degree of malocclusion is determined by changes from before to after surgery.
Intra-Arch Molar Distance
时间窗: 4, 8, and 12 weeks
Before and after surgery, the inter-molar distance between the maxillary first molars was measured in millimeters using a digital caliper. measured using a digital caliper across the first molars' mesiobuccal cusp points before and after surgery; a change signifies collapse or widening of the arch.
次要结局
- Occlusal Stability(4, 8 and 12 weeks)
研究者
Muhammad Hassan
Muhammad Hassan
Services Institute of Medical Sciences, Pakistan