NCT06051266招募中不适用
Clinical Accuracy Evaluation of Dynamic Navigation and Static Template for Dental Implant Placement in Completely Edentulous Patients: A Randomized Parallel Controlled Multicenter Clinical Trial
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2023年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Apical deviation of implant placement (mm)
研究概览
简要总结
The study was a prospective, multicentre, randomized parallel controlled clinical trial. Randomisation was conducted by central randomisation, with random allocation codes generated by the main central computer. Enrollment was conducted by competition between different centres. In this study, the coronal, apical and angular deviations (mean, standard deviation, median, quartiles, minimum, maximum, 95% confidence interval) of the static template and dynamic navigation group guided implant placement were calculated. The data is proposed to be analysed using a mixed linear effects model.
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 (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and above
- •American society of anesthesiologists (ASA) Levels 1 and 2
- •Satisfy any of the following requirements:
- •Edentulous maxillary patients
- •Edentulous mandibular patients
- •Terminally edentulous maxillary patients (number of remaining natural teeth in the upper jaw 1-4)
- •Terminally edentulous mandibular patients (number of remaining natural teeth in the lower jaw 1-4)
- •Full-mouth edentulous patients
- •Full-mouth terminally edentulous patients (number of remaining natural teeth in one jaw 1-4)
- •Implant-supported fixed restorations or implant-supported overdenture restorations
- •Sufficient usable bone volume at implant sites, non-implant sites (≥1.5mm of remaining bone width on the labial/buccal and palatal/lingual sides after virtual implant placement in software)
- •Maxillary and mandibular options for full-mouth patients are based on the inclusion of more single jaws in the non-bone grafted sites (see virtual peri-implant bone volume requirements in the pre-operative preparation phase)
- •Mouth opening of 3 fingers or more
- •Single-jawed missing patients treated with systemic periodontal therapy
排除标准
- •Have a systemic disease that may affect prognosis (e.g. diabetic patients with glycated haemoglobin >6.5%, patients on bisphosphonate medication, patients with auto-systemic immune diseases, etc.)
- •ASA grades 3 and 4
- •Acute inflammation in the oral cavity: including uncontrolled periodontitis (periodontal probing depth > 4 mm) and untreated acute and chronic apical periodontitis
- •Pregnancy or breastfeeding
- •History of radiotherapy to the head and neck
- •Heavy smokers (more than 10 cigarettes per day)
- •Restricted mouth opening (less than three fingers).
- •Participation in a clinical trial with another drug or device within 30 days prior to the start of the procedure (study day 0).
结局指标
主要结局
Apical deviation of implant placement (mm)
时间窗: About 3 days after surgery
Preoperative planning and postoperative cone-beam computed tomography (CBCT) were aligned together in the software and apical deviations(mm) of implant placement were measured to compare the results of the two groups.
次要结局
- Change of marginal bone level(mm)(About 1 year after surgery)
- Implant stability quotient(Surgery day)
- visual analogue scale(About 3 days after surgery)
- Operation time(Surgery day)
- Coronal deviation of implant placement (mm)(About 3 days after surgery)
- Angular deviation of implant placement (°)(About 3 days after surgery)
- Failure rate(About 4 months after surgery)
研究者
研究点 (1)
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