Influence of Abutment Angulation on Implant Failure in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides: RCT
Implant Failure When Using Angled Versus Straight Abutments in Immediately Placed and Restored Implants in the Esthetic Zone Using Computer Aided Surgical Guides:A Randomized Clinical Trial
研究概览
详细说明
A: General operative procedures:
The study will be explained in details to the eligible participants with all possible alternative treatment options and possible risk.
If a patient accepts the treatment, informed consent will be signed. Standard extra oral and intraoral examination will be carried out. Diagnostic charts will be filled including medical and past dental history.
The patient will choose a sealed envelope to determine the allocation group. Preliminary impressions will be taken. The tooth to be extracted will be trimmed from the cast and an ideal wax up will be done.
A hard vacuum stent 2 mm thickness will be constructed over the cast with the wax up for fabrication of the temporary crown later.
The patient will be imaged a cone beam computerized topography (CBCT). The acquired DICOM image will be assessed on blue sky software ®. All the cases must have adequate buccolingual bone, if not the patient will be excluded from the study.
The co-supervisor (MW) will inform the principle investigator (HF) with the allocation group.
The principle investigator (HF) will plan the case. The implants will be planned apical to socket depth to engage apical bone for better primary stability. Final implant position 3 dimensionally will be according to allocation group to allow for placement of either straight or angled abutment.
The guide will be exported from the software and printed.
Intra operative procedures:
Patients will administrate a prophylactic antibiotic 3 days ahead the surgery. The procedure will be carried out under local anesthesia under sterile conditions.
The remaining tooth will be extracted atraumatically using periotome for better bone preservation.
After tooth extraction, the socket will be curettaged and irrigated with copious saline till fresh bleeding from the socket is observed.
Surgical guide will be placed and checked for stability and drilling will be performed following instructions.
Before implant insertion, the prepared osteotomy will be lavaged thoroughly to remove any drill debris from the socket.
The implant will be placed and the insertion torque will be checked using manual torque wrench. Implants with insertion torque less than 35Ncm will not be loaded and will be excluded from the study.
Periapical radiographs will be taken to ensure proper seating of the implant. The abutment, whether straight or angled according to the allocation group, will be attached to the implant fixture.
The vacuum stent will be used to perform the temporary crown using autopolymerizing resin. The crown will be checked to be out of occlusion in centric and eccentric occlusion to avoid any premature contact and subsequent overloading. Then the crown will be cemented and excess cement will be removed using dental floss.
The patient will be called for follow up after 1 week for the first 3 weeks then at 1 month and 3 months.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Giza、埃及
- Faculty of Dentistry
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients with teeth or remaining roots indicated for extraction in the esthetic zone and eligible for immediate implant placement Sufficient bone labially (at least 1.5-2 mm) assessed after cone beam computer tomography (CBCT) scan Presence of adequate mesio distal length between the adjacent natural teeth (at least 7 mm), measured on the study cast Presence of adjacent natural teeth to the tooth/teeth to be extracted
Exclusion Criteria:
- Presence of active signs or symptoms of acute infection in the tooth or the remaining root Heavy smokers (more than 2 packs per day) Parafunctional habits (clenching or bruxism) diagnosed by history taking and observation of the occlusal surface of the posterior teeth for wear facets Patients with poor oral hygiene Pregnant women Any systemic condition that may interfere with osseointegration (as uncontrolled diabetes, recent head and neck radiation) Severe overeruption of the opposing teeth to avoid any premature contact with the temporary crown during the osseointegration period.
学习计划
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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实验性的:Angled abutment
According to the allocation, the experimental group will receive an angled abutment on the immediately placed implant.
A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany)
|
virtual implants will be placed on a planning software allowing abutments to be placed at an angle to the implant.
Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide.
The angled abutment will be placed and a temporary crown material will be fabricated.
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有源比较器:Straight abutment
According to the allocation, the control group will receive on the immediately placed implant a Straight zero degree abutment .
A vaccum stent will be used to fabricate a temporary crown using tooth colored auto-polymerizing resin(structur 2 SC/ QM , VOCO GmbH, Germany)
|
virtual implants will be placed on a planning software allowing abutments to be placed at straight to the implant.
Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide.
The straight abutment will be placed and a temporary crown material will be fabricated.
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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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Implant failure
大体时间:3 months interval
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clinical observation
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3 months interval
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合作者和调查者
出版物和有用的链接
一般刊物
- Araújo, M.G. et al., 2005. Ridge alterations following implant placement in fresh extraction sockets: an experimental study in the dog. Journal of clinical periodontology, 32(6), pp.645-52. Brosh, T., Pilo, R. & Sudai, D., 1998. The influence of abutment angulation on strains and stresses along the implant/bone interface: comparison between two experimental techniques. The Journal of prosthetic dentistry, 79(3), pp.328-34. Chrcanovic, B.R., Albrektsson, T. & Wennerberg, A., 2015. Tilted versus axially placed dental implants: a meta-analysis. Journal of dentistry, 43(2), pp.149-70. Del Fabbro, M. et al., 2015. Immediate loading of postextraction implants in the esthetic area: systematic review of the literature. Clinical implant dentistry and related research, 17(1), pp.52-70.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Prosth department
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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