Treatment Outcomes With Full Arch Rehabilitations Retained by Immediate or Conventionally Loaded Implants (ILOD)
2021年6月17日 更新者:JAVIER MONTERO、University of Salamanca
Treatment Outcomes With Full Arch Rehabilitations Supported by Immediate or Conventionally Loaded Implants: A Randomized Clinical Trial
This study aims to assess the treatment outcomes (clinical, functional and subjective) of full arch rehabilitations supported by implants with or without an immediate loading protocol.
In this randomized clinical trial 20 fully edentulous patients were treated with full arch rehabilitations on dental implants.
In half of the sample, the implants were loaded immediately by means of abutments after emplacement of the implant; but in the counterparts these abutments were connected to implants two months after the surgery (conventional protocol), and until that time the dentures were retained by healing abutments.
Treatment outcomes were assessed at 2, 6 and 12 months after surgery.
Clinical outcomes were quantified on the basis of implant failure rate, marginal bone loss and the peri-implant gingival index.
Functional outcomes were calculated according to masticatory performance, estimated by the mixed fraction of a two-coloured chewing gum after 5, 10 and 15 chewing strokes, by the occlusal force recorded by pressure-sensitive sheets and by the bioelectrical muscular activity.
The subjective outcomes of the treatment were assessed using both the oral satisfaction scale (visual analogue scale) and the Spanish version of the Oral Health Impact Profile (OHIP-20).
研究概览
研究类型
介入性
注册 (实际的)
20
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
-
-
-
Salamanca、西班牙、37007
- Clinica Odontológica de la Universidad de Salamanca
-
-
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:
- completely edentulous individuals who had lacked teeth for more than 10 years, routine users of conventional complete prostheses.
- sufficient amount of remaining bone to receive the implants in the region of the mandibular canines (minimum height=15 mm/minimum ridge width= 5mm)
- no evidence of systemic or psychic pathology that might contraindicate the implant treatment.
Exclusion Criteria:
- Those in which oral surgery or cognitive evaluations are contraindicated
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:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Conventional Loading
implants are loaded at least after two months of healing
|
Placement of dental implants with different loading protocols for supporting full arch dentures.
|
|
实验性的:Immediate Loading
implants are loaded the same day of surgery
|
Placement of dental implants with different loading protocols for supporting full arch dentures.
|
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 |
|---|---|---|
|
Clinical Performance of Dental implants
大体时间:One year after treatment
|
Implant failure rate
|
One year after treatment
|
|
Oral health-related quality of life
大体时间:One year after treatment
|
impact according to the OHIP-20 (Oral Health Impact Profile) instrument.
The score range from 0 to 20, being 20 the worst outcome.
|
One year after treatment
|
|
Mastication
大体时间:One year after treatment
|
Mixing ability tests
|
One year after treatment
|
|
Area of Occlusal Occlusion
大体时间:One year after treatment
|
According to pressure-sensitive colorimetric sheets it is recorded the area in square millimeters
|
One year after treatment
|
|
Occlusal Load
大体时间:One year after treatment
|
According to the pressure-sensitive colorimetric sheets , the load in both the anterior and posterior region of the arch are calculated.
|
One year after treatment
|
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。
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 (实际的)
2018年1月11日
初级完成 (实际的)
2018年1月11日
研究完成 (实际的)
2021年1月11日
研究注册日期
首次提交
2021年6月10日
首先提交符合 QC 标准的
2021年6月17日
首次发布 (实际的)
2021年6月18日
研究记录更新
最后更新发布 (实际的)
2021年6月18日
上次提交的符合 QC 标准的更新
2021年6月17日
最后验证
2021年6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.