Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates
2016年8月15日 更新者：Zhuofan Chen、Sun Yat-sen University
Accuracy of Dental Implant Placement Using Two Different CBCT-derived Templates: a Randomized Controlled Clinical Trial
The main purpose of the present study is to evaluate the dental implant placement using two different CBCT-derived templates and to study the related factors that affect accuracy so as to support the further clinical application of the technique.
Thirty patients with partial edentulous denture are recruited.
They are randomized to two groups.
A radiographic guide is prepared before CT/CBCT scan.
The CT/CBCT scan DICOM files are loaded in a planning program and converted into 3D computer images.
A surgical template is fabricated through this virtual planning.
After 6 weeks, if the implants are judged stable, the patient has the option of replacing the fixed prosthesis.
Patients are recalled for oral hygiene maintenance and prosthetic controls every 6 months for the entire duration of the study.
研究概览
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510000
- 招聘中
- Guanghua school of stomatology, hospital of stomtology, Sun Yat-sen University
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接触：
- Zhuofan Chen, professor
- 电话号码：＋8613902241868
- 邮箱：dentistczf@163.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Partial edentulism
- Missing more than three teeth in succession
- Presence of adjacent teeth
- Systemically healthy
- Good maxillomandibular relation
- Maximal mouth opening>5 mm
Exclusion Criteria:
- Poor oral hygiene
- Severe parafunctional habits, for example, bruxing and clenching
- Presence of clinically active periodontal disease as expressed by probing pocket depths≥4 mm in combination with bleeding on probing
- Maxillary sinus involvement
- Conditions that might lead to a possibly lowered regenerative capacity of the bone, for example, osteoporosis and Paget's disease
- Pregnant or expecting to be pregnant
- History of drug and alcohol abuse
- History of systemic diseases that would contraindicate oral surgical treatment, for example, uncontrolled diabetes (defined as HBA1c level >7%)
- Radiotherapy in the head and neck area
- On certain medications like bisphosphonates or steroids currently or within the past three months
- Unwillingness to return for the follow-up examination
- Smokers (more than20 cigarettes per day). Subjects smoking <20 cigarettes per day were requested to stop smoking before and after surgery
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：GuideMia surgical template
A radiographic guide is prepared before CT/CBCT scan.
The CT/CBCT scan DICOM files are loaded in GuideMia program and converted into 3D computer images.
A surgical template is fabricated through this virtual planning.
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其他名称：
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有源比较器：Control surgical template
A radiographic guide is prepared before CT/CBCT scan.
The CT/CBCT scan DICOM files are loaded in control program and converted into 3D computer images.
A surgical template is fabricated through this virtual planning.
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Position changes between the planned and achieved implant position
大体时间：Change from preoperative to postoperative within 1 week
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Accuracy analysis.
The linear and angular deviations between the planned and achieved implant position are analyzed.
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Change from preoperative to postoperative within 1 week
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Implant and prosthesis survival
大体时间：Up to 18 months after baseline
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Implant and prosthesis survival will be determined at 6 months，12months and 18 months
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Up to 18 months after baseline
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Radiographic bone level
大体时间：Up to 18 months after baseline
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Radiographic bone level will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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The incidence of biological and mechanical complications
大体时间：Up to 18 months after baseline
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The incidence of biological and mechanical complications will be recorded at baseline, 6 months，12months and 18 months
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Up to 18 months after baseline
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Probing depth
大体时间：Up to 18 months after baseline
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Probing depth will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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Modified plaque index
大体时间：Up to 18 months after baseline
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Modified plaque index will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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Modified bleeding index
大体时间：Up to 18 months after baseline
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Modified bleeding index will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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Gingival index
大体时间：Up to 18 months after baseline
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Gingival index will be recorded at 6 months，12months and 18 months
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Up to 18 months after baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Zhuofan Chen, professor、School of Stomatology, Hospital of Stomatology, Sun Yat-Sen University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Lopes A, Malo P, de Araujo Nobre M, Sanchez-Fernandez E. The NobelGuide(R) All-on-4(R) Treatment Concept for Rehabilitation of Edentulous Jaws: A Prospective Report on Medium- and Long-Term Outcomes. Clin Implant Dent Relat Res. 2015 Oct;17 Suppl 2:e406-16. doi: 10.1111/cid.12260. Epub 2014 Sep 5.
- Sun Y, Luebbers HT, Agbaje JO, Schepers S, Politis C, Van Slycke S, Vrielinck L. Accuracy of Dental Implant Placement Using CBCT-Derived Mucosa-Supported Stereolithographic Template. Clin Implant Dent Relat Res. 2015 Oct;17(5):862-70. doi: 10.1111/cid.12189. Epub 2013 Dec 16.
- Polizzi G, Cantoni T. Five-year follow-up of immediate fixed restorations of maxillary implants inserted in both fresh extraction and healed sites using the NobelGuide system. Clin Implant Dent Relat Res. 2015 Apr;17(2):221-33. doi: 10.1111/cid.12102. Epub 2013 Jun 23.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年8月1日
初级完成 (预期的)
2017年11月1日
研究完成 (预期的)
2018年2月1日
研究注册日期
首次提交
2016年5月4日
首先提交符合 QC 标准的
2016年5月11日
首次发布 (估计)
2016年5月13日
研究记录更新
最后更新发布 (估计)
2016年8月17日
上次提交的符合 QC 标准的更新
2016年8月15日
最后验证
2016年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.