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临床试验/NCT05589545
NCT05589545Enrolling By Invitation不适用

Full-arch Rehabilitation of Severely Atrophic Maxillae Through the Use of Polyetheretherketone (PEEK) Prostheses Supported by Zygomatic Implants in Combination With Conventional Implants Through the All-on-4 Concept.

Malo Clinic2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
10
试验地点
2
主要终点
Survival of the prosthesis

研究概览

简要总结

The goal of this study is to evaluate the outcome of a Poly-ether-ether-ketone - acrylic resin prosthesis for full-arch rehabilitation of the atrophic maxillae through the All-on-4 Hybrid concept (standard and zygomatic implants) after one year of follow-up. The main question it aims to answer is:

  • What is the survival outcome of the full-arch implant-supported Poly-ether-ether-ketone - acrylic resin prosthesis? The participants already rehabilitated with dental implants will receive a Poly-ether-ehter-ketone prosthesis as a definitive prosthesis.

详细描述

Following the previous study on the full-arch rehabilitation of edentulous jaws using hybrid prostheses with polyetheretherketone (PEEK) infrastructure and acrylic resin teeth supported by implants in immediate function inserted through the All-on-4 concept it is necessary to further extend the evaluation to the full-arch rehabilitation of severily atrophic maxillae through the use of the same hybrid prostheses supported by immediate function zygomatic implants inserted alone or in combination with conventional implants. To test this, the study design to be used will be a single-centre, prospective, observational cohort study to evaluate the short term outcome of fixed prosthetic implant-supported rehabilitations. The sample of this study consists in 10 patients consecutively treated. The cohort will be evaluated after 4 to 8 weeks, 6 months, 12 months after connection of the prostheses and annually thereafter as long as the patient is willing, regarding: prosthetic survival, implant survival, marginal bone resorption, incidence of mechanical complications (loosening or fracture of prosthetic components), biological complications (peri-implant infection, suppuration, fistulae, sinus infection, gingival dehiscence), patient tissue reaction, aesthetic examination including staining, color stability and anatomic form; patient assessment of in mouth comfort, overall chewing ability, aesthetics and patient quality of life using the Oral Health Impact Profile OHIP-14 questionnaire; assessment of prosthetic preparation (technician satisfaction) concerning laboratory preparation time, clinical operative time and costs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Subjects who, in the opinion of the Investigator, are able to understand this clinical study, co-operate with the procedures and are willing to return to the clinic for all the required post-operative follow-ups.
  • Subjects who are able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained.

排除标准

  • Female Subjects who are pregnant.
  • Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-ups or treatment outcomes.
  • Subjects with any condition that would compromise their participation and follow-up in this clinical study.
  • Subjects who are currently enrolled in a clinical study.

结局指标

主要结局

Survival of the prosthesis

时间窗: one year

Evaluation of the survival for the PEEK-acrylic resin implant-supported prosthesis; nominal (survival,failure)

次要结局

  • Overall Chewing ability(one year)
  • Marginal bone resorption (standard implants)(one year)
  • Denture staining(one year)
  • Laboratory preparation time(one year)
  • Incidence of mechanical complications(one year)
  • Oral Health Impact Profile(One year)
  • Survival of the implants(one year)
  • Anatomic form(one year)
  • Patient tissue reaction(one year)
  • Color stability(one year)
  • ln mouth comfort(one year)
  • Incidence of biological complications(one year)
  • Aesthetics(one year)
  • Clinical operative time(one year)

研究者

发起方
Malo Clinic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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