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临床试验/NCT03305679
NCT03305679已完成不适用

Evaluation of the Clinical Efficacy of the Immediate Implant Loading in the Aesthetic Zone

Damascus University4 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2017年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
Change in the Plaque Index

研究概览

简要总结

Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).

Materials and methods:

20 implant in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Esthetic assessment and patient acceptance will be assessed using specific tools.

Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.

详细描述

Aim: The aim of this study to Assess the healing process of the immediate implant loading with two different provisional techniques (direct and indirect).

Materials and methods

20 implant (Implant Direct ) in the aesthetic zone either in the incisor or in the canine area and excluding the lateral location and then immediate loading is achieved for the 20 implants (10 for direct and 10 for indirect method) Clinical Aspect :color change , healing and bone resorption Aesthetic assessment and patient acceptance will be assessed using specific tools Lab aspect: surface roughness and Marginal fit will be measured to have clue vision.

The participants were non-dental students from University colleges in and around Damascus. They were recruited by reviewing the case documents 20 patient with hapless incisal and canine for extraction and immediate implantation and immediate loading with either the two different provisional methods participants had to demonstrate a hopeless central incisor or canine with no perio-active infection. With two types of provisional technique we will have a two groups were calculated a priori in such a way that index can be identified with with alpha = .05 in a two-tailed test, a sample size of 2 X10 implants would result in a power of 94% (g power 3.1.3) based on a pilot study.

Cone-beam computed tomography (CBCT) images for each patient to measure the bone level change and aesthetic assessment by three general dentists will be achieved. Replica technique required the application of impression material build up of addition-silicone. Addition-silicone of very low viscosity (ExpressTM2 Ultra-Light Body Quick) was applied to all restorations interior, after which the crowns were set onto basic samples. Impression material was polymerized within the time which is recommended by the manufacturer, while the pressure force of 50 N was applied toward occlusal direction After the removal of all restorations from the basic samples, the layer of impression material remained on the restoration's inner surface due to its higher roughness compared to the abutment surface. With Rt 200 device the roughness will bw measured and then Scanning Electronic Microscope (SEM) images will give a close understanding of the surface. Easy shade will measure the color change.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • esthetic request.
  • either incisor or canine indicated for extraction.
  • symmetrical gingival level.
  • no active periodontal disease.
  • age between 20-40 years old

排除标准

  • Lateral hopeless tooth .
  • Active periodontal lesion .
  • loss of periodontal tissue .
  • missed incisor or missed canine in the area of implantation.

研究组 & 干预措施

Direct provisional technique

Experimental

Patients here will be subjected to the direct provisional technique

干预措施: Direct provisional technique (Procedure)

Indirect Provisional technique

Active Comparator

Patients here will be subjected to the indirect provisional technique

干预措施: Indirect Provisional technique (Procedure)

结局指标

主要结局

Change in the Plaque Index

时间窗: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation

This will be measured using the the plaque index

Change in the Gingival Index

时间窗: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation

This will be measured using the the gingival index

Change in alveolar bone level

时间窗: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation

This will be measured using cone-beam computed tomography images

Change in Esthetic Appearance

时间窗: T1: at one day before implantation, T2: at three months following implantation

This will be measured by using the White Esthetic Scale (WES)

Change in the Pink Esthetic Scale

时间窗: T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation

This will be measured using the Pink Esthetic Scale

次要结局

  • Change in Restoration Color(T1: at one day after implantation, T2: at one month following implantation, T2: at two months following implantation, T3: at three months following implantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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