Bone Dimensional Changes at Different Implant-to-abutment Connections: a 1-year Clinical and Radiological Study
Aim of the present study will be to evaluate if the platform switching and the flat abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.
80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.
研究概览
详细说明
BACKGROUND:
Platform switching is intended to preserve marginal bone around implants. Studies have shown that implants using an integrated platform switching demonstrate crestal bone loss as low as 0.37mm, and 30 to 50% reduction in crestal bone loss when compared to non-platform switching implants. Recently, a new design titanium abutment (Tissuemax IL) has been proposed to modulate the soft tissue integration around implant supported crowns. A new implant with a hybrid surface (T3) has been recently launched by Biomet 3i, providing both integrated platform switching (Prevail) or non platform switching (Standard Collar).
Aim of the present study will be to evaluate if the platform switching and the Tissuemax abutment can modify the peri-implant marginal bone remodelling. A clinical assessment of the soft tissues will also be provided.
MATERIALS & METHODS:
80 consecutively inserted dental implants will be included in this study. Maxillary and mandibular implants will be considered, both in frontal and posterior area. Implants should be inserted in preexisting adequate bone volume, without the need for any bone augmentation technique. Implants will be inserted with a transmucosal healing (single-stage surgical procedure) with immediate connection of the healing abutment. After 6 to 12 weeks, the definitive prosthetic abutment will be screwed and the temporary crown cemented. After 2 more months, the definitive porcelain crown will be delivered. The final outcomes will be collected after 1 year from implant insertion.
Data will refer to the following timing:
T0= implant installation T1= temporary crown cementation T2= definitive crown cementation T3= 1 year follow-up The 80 implants will be randomly divided into 4 groups of 20 implants each, with different implant/abutment design.
Group 1: Tapered T3 Standard Collar implants + GingiHue abutments Group 2: Tapered T3 Standard Collar implants + Tissuemax IL abutments Group 3: Tapered T3 Prevail implants + GingiHue abutments Group 4: Tapered T3 Prevail implants + Tissuemax IL abutments The division into the 4 group will be randomized. Standardized intraoral radiograms will be done at T0, T1, T2 and T3. On x-rays, the mesial and distal Marginal Bone Level will be measured and compared among and between the groups at the 4 different timing.
Pocket Depth and Bleeding on probing (mesial, buccal, distal and lingual) will be measured at T0, T1, T2 and T3. Data will be statistically analyzed.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
TO
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Torino、TO、意大利、10129
- PROED, Institute for Professional Education in 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:
- Healthy adult patients with partial edentulism
Exclusion Criteria:
- Current pregnant patients
- History of malignancy
- History of radiotherapy or chemiotherapy in the last 5 years
- Long term steroidal or antibiotic therapy
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 |
|---|---|
|
有源比较器:standard platform , standard abutment
implant insertion and abutment connection Osseointegrated implants with regular collar connected to standard designed prosthetic abutments
|
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
|
|
有源比较器:standard platform, flat abutment
implant insertion and abutment connection Osseointegrated implants with regular collar connected to flat designed prosthetic abutments
|
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
|
|
有源比较器:switching platform, standard abutment
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to standard designed prosthetic abutments
|
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
|
|
有源比较器:switching platform, flat abutment
implant insertion and abutment connection Osseointegrated implants with switched platform collar connected to flat designed prosthetic abutments
|
After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
|
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 |
|---|---|---|
|
Marginal Bone Level
大体时间:1 year after implant installation
|
On standardized intraoral radiograms, mesial and distal marginal bone level at implant surface will be measured
|
1 year after implant installation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Probing Pocket Depth
大体时间:1 year after implant installation
|
Probing depth measured mesially, buccaly, distally and lingually at implant site
|
1 year after implant installation
|
|
Bleeding on Probing
大体时间:1 year after implant installation
|
Bleeding on Probing measured mesially, buccaly, distally and lingually at implant site
|
1 year after implant installation
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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