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临床试验/NCT03425864
NCT03425864已完成不适用

Pink Esthetic Score Evaluation After Soft Tissue Augmentation Using Connective Tissue Graft Around Immediate Dental Implants Versus Immediate Dental Implants Alone in Esthetic Zone

Nada Farouk Hasan Abd El-Aziz1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年7月11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
发起方
入组人数
3
试验地点
1
主要终点
pink esthetic score

研究概览

简要总结

The goal of the present study is to compare the esthetic result and stability of gingival tissue over the immediate implant only and immediate implant with connective tissue in patients with single non-restorable tooth in the esthetic zone. The main null hypothesis to be tested is that the addition of SCTG to immediately placed implants will not significantly differ from immediately placed implant alone as regard gingival tissue stability.

详细描述

Implant became a treatment modality for replacing missing or non-restorable teeth, providing clinical success rate and esthetic outcome. (1) In esthetic zone the main goal is not only the preservation of function but also the preservation of the esthetics. The esthetic outcome of implant supported restoration depend on the soft tissue volume and the soft tissue contour. (2) The placement of immediate implant after tooth extraction was proved as a very high success rate treatment modality. It provided several advantages such as reduction of the time between tooth extraction and the placement of prosthesis, reduction of the number of surgical treatments (3) and increase osteointegration between bone and implant surface (4).

Considering the survival rate of immediate implantation versus delayed implantation there is no significant difference with an overall success rate of 99.6%, it is just considered as a successful treatment modality, based on 802 implants (5).

On the other hand disadvantage related to esthetic outcome has been reported, showing facial gingival recession following the first year of function due to labial bone plate resorption. (6, 2).

A systematic review by Sanz et al.,(2012) compared the reduction of bone height and bone width between two groups the control group was delayed implant placement and the studied group was immediate implant placement and the mean difference between groups was of 13.11% (95% CI: from 3.83 to 22.4; P = 0.057) and 19.85% (95% CI: from 13.85 to 25.81)respectively, concluding that the early placement of dental implants after tooth extraction offers advantages in terms of soft and hard tissue preservation, compared with delayed implant placement , which affect the aesthetic (7 ) As a sequence of dimensional ridge alterations that occur following tooth extraction many studies reported a recession of marginal peri-implant mucosa, which affect the aesthetic outcome (8, 9, and 10).

A study made by Migliorati et al., (2015) between two groups, the control group (immediate loading implant treated without raising a flap) and the test group (immediate loaded implant treated with sub-epithelial connective tissue graft (SCTG) using the tunnel technique in the labial area) Both groups (47 implants) received deproteinized bovine bone minerals and implants were successfully integrated with a follow up period 2-year examination . Moreover the mean recession in the control group was 0.71mm (17.58%), one third of the control group reported recession >1mm, and mean pink aesthetic score (PES) was 6.65, resulting in bad aesthetic. The test group showed an increase of the keratinized mucosa (KM) with a mean of 34.29% (0.5mm) and a mean recession of 0.2mm (10.01%), only one case (4%) showed recession >1mm and the mean PES was 8. The thickening of soft tissue by the addition of SCTG, lead to compensation and maintenance of the loss of bone volume in the labial area (11).

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
Double (Participant, Outcomes Assessor)

盲法说明

Double blinded Blinding will be done to the clinical, radiographic assessors, without involving them in sequence generation or allocation concealment or surgery performing.

Blinding of the biostatistian.

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Non-restorable teeth located within the maxillary anterior area and premolars. Age ranged between 20 to 50 years old. Sufficient vertical inter-arch space upon centric occlusion. Patients with good oral hygiene. Intact labial/buccal bone plate.
  • •a. Inclusion criteria
  • •Patients with single non-restorable teeth in anterior or premolar area.
  • •"Patients with adequate bone volume for the dental implant procedure".
  • •Patients who are compliant to oral hygiene measures.
  • •Patient consent approval and signing.

排除标准

  • •Patients with any systemic disease that could affect normal healing of tissue and predictable outcome.
  • •Patients with any habits that might affect osseointegration, such as heavy smoking and alcoholism.
  • •Pregnant women.
  • •Patients with untreated periodontal disease or the presence of pathologic condition at implant site.
  • •Patients with Parafunctional habits that produce overload on the implant such as bruxism and clenching.
  • •Shallow palate.

研究组 & 干预措施

immediate implant

Other

patient will receive immediate implant alone.

干预措施: immediate implant (Device)

immediate implant with connective tissue graft

Active Comparator

patient will receive immediate implant and connective tissue gaft

干预措施: connective tissue graft (Procedure)

immediate implant with connective tissue graft

Active Comparator

patient will receive immediate implant and connective tissue gaft

干预措施: immediate implant (Device)

结局指标

主要结局

pink esthetic score

时间窗: should be measured after 8 months below implant and graft placement

evaluation of pink esthetic score around immediate implant only in esthetic zone around immediate implant with connective tissue graft in esthetic zone

次要结局

  • tissue piotype(should be measured after 6 months below implant and graft placement)
  • width of keratinized gingiva(should be measured after 6 months below implant and graft placement)

研究者

发起方
Nada Farouk Hasan Abd El-Aziz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nada Farouk Hasan Abd El-Aziz

Assistant Specialist

Cairo University

研究点 (1)

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