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临床试验/NCT05381467
NCT05381467已完成不适用

The Bone Shielding Versus Dual Zone Concept in Treating Thin Walled Fresh Extraction Sockets With Immediate Implant Placement Soft and Hard Tissue Changes A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年3月1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
24
试验地点
1
主要终点
Pink Esthetic Score

研究概览

简要总结

Immediate implant placement has proven to be a successful treatment procedure that is preferred by patients because of being less traumatic, more time-efficient. Nowadays, the main goal of a successful immediate implant treatment has ceased to be gaining stability and osseointegration, but achieving long-term dimensional stability has become the optimal challenge. Various soft tissue and hard tissue augmentation techniques have been investigated in order to maintain the ridge dimensions following extraction and immediate implant placement.

详细描述

It has been noted that the different augmentation procedures aid in decreasing the dimensional changes occurring after immediate implant placement in the esthetic zone. Even though immediate implant placement is a predictable procedure, however, labial bone resorption following tooth extraction is inevitable. The available surgical techniques present do not entirely prevent dimensional variations of the peri-implant hard and soft tissues over time. Furthermore, substantial evidence showed that immediate implant placement failed to halt the resorption of the thin buccal bony plate with subsequent gingival recession, particularly in patients with thin gingival phenotype

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)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •adult (>18 years) patients having a single non-adjacent hopeless maxillary tooth in the esthetic zone
  • •type I socket (intact but thin labial plate of bone and intact overlying soft tissues)
  • •adequate palatal bone
  • •≥3 mm apical bone to engage the immediately placed implants
  • •optimum primary stability (a minimum of 30 Ncm insertion torque) following tooth extraction.

排除标准

  • •pregnant women
  • •patients with systemic diseases
  • •periodontal disease, gingival recession
  • •infected sockets
  • •periapical pathosis and history of chemotherapy or radiotherapy within the past 2 years.

研究组 & 干预措施

immediate implant placement with The Dual-Zone Therapeutic Concept

Active Comparator

干预措施: immediate implant placement with The Dual-Zone Therapeutic Concept (Procedure)

Immediate implant placement with the bone shielding concept

Experimental

干预措施: Immediate implant placement with the bone shielding concept (Procedure)

结局指标

主要结局

Pink Esthetic Score

时间窗: 6 months

Pink Esthetic Score 1-14 score PES

次要结局

  • Implant failure(6 months)
  • labial bone thickness(6 months)
  • Peri-implant probing depth(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nesma Mohamed Fouad Shemais

PhD holder Lecturer in the department of Oral Medicine & Periodontology

Cairo University

研究点 (1)

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