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临床试验/NCT05989061
NCT05989061招募中不适用

PEEK Versus Titanium Customized Healing Abutments: Evaluation of Peri-implant Soft Tissues and Sulcus Fluid Bacterial Load

Ain Shams University1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
26
试验地点
1
主要终点
Clinical evaluation of peri-implant soft tissue changes

研究概览

简要总结

The study suggests that if the investigators used customized healing abutments synthesized from PEEK may have a favorable effect on peri-implant soft tissues regarding decreased plaque accumulation and healing stimulation compared to the customized conventional titanium healing abutments.

详细描述

Successful aesthetic implant therapy has several sequential goals such as prosthetically driven 3D implant placement. Implant placement must be done in the ideal position to support the restoration and the surrounding soft and hard tissues. The placement of a definitive restoration should also be in harmony with the adjacent natural teeth and surrounding soft tissue.

Guided implant surgery can provide precise, predictable, and safe implant placement. Computer-generated surgical guides vary in design according to the dental condition (edentulous or partially edentulous), type of support (tooth, mucosa, or bone), and the degree of limitation (non-limiting, partially-limiting, or completely limiting).

The use of healing abutments has the function which enables adequate healing of peri-implant soft tissue and promoting a good profile of peri-implant mucosa that allows an adequate emergence profile of the prostheses supported by the implant. They are available in different lengths and project through the soft tissue into the oral cavity.

Janakievski stated that prefabricated healing abutments are unable to support the supracrestal soft tissues because of their circular profile. Therefore, a custom healing abutment is preferred because it provides a replica of the definitive restoration of the patient's gingival architecture.

An evaluation of the use of customized healing abutments has been performed aiming to assess possible advantages associated with this treatment modality. This procedure allows to maintain the peri-implant tissue and improve aesthetics until crown delivery. CAD/CAM enables the fabrication of high-quality implant abutments from solid blocks of different materials.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Patients should be systematically free from any disease as according to Cornell Medical Index-Health Questionnaire .
  • Both genders.
  • Age from 20-50 years.
  • Missing tooth in esthetic zone (Anterior/Premolar) to be restored with standard implant, with no need for additional bone and soft tissue augmentation procedures.
  • Implants primary stability ISQ ≥ 70 unites using the Osstell Mentor
  • BuccoLingual bone width ≥ 6 mm.
  • Mesio distal space ≥ 7 mm
  • Sound Mesial and distal neighboring teeth.
  • At least 6 natural teeth remaining in the same arch .
  • Mouth opening ≥ 30mm.
  • Enough keratinized mucosa.
  • Thick phenotype.

排除标准

  • Poor oral hygiene condition.
  • Pregnant and lactating females.

结局指标

主要结局

Clinical evaluation of peri-implant soft tissue changes

时间窗: 1 month after implantation and 4 months after implantation (just before prosthetic procedures)

Clinical evaluation of peri-implant soft tissue changes the Probing Depth (PD).

次要结局

  • Biochemical evaluation(1 month after implantation and 4 months after implantation (just before prosthetic procedures))

研究者

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

Samar El Desouki

Principal Investigator

Ain Shams University

研究点 (1)

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