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临床试验/NCT06967649
NCT06967649Enrolling By Invitation不适用

Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants

Universidade Federal Fluminense2 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2022年11月4日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
350
试验地点
2
主要终点
PRIMARY IMPLANT STABILITY

研究概览

简要总结

The success of rehabilitation with osseointegrated implants is associated with numerous factors, including patient characteristics, installed implants, proper planning, and the prosthetic connections used. In the long term, success is closely related to the clinical radiographic follow-up of the implanted region and the identification of intrinsic or extrinsic factors that may interfere with implant survival. Therefore, the objective of this study is to evaluate, through clinical and radiographic analysis, the peri-implant tissues and prosthetic connections of research participants rehabilitated with osseointegrated implants at the Implant Dentistry Clinic of the Federal Fluminense University, over a period of 5 years. This will be a double-blind longitudinal study. A total of 148 research participants will be selected, respecting the inclusion criteria: completion of surgical-prosthetic planning by the Implant Dentistry Clinic team at UFF, including osseointegrated implants and prosthetic components manufactured by SIN Implant System (São Paulo, Brazil); agreeing to and signing the informed consent form, being willing to be monitored for a period of 5 years; systemically healthy patients who do not use antiresorptive and antiangiogenic drugs; patients with a plaque index <20% (Ainamo & Bay 1975) and bleeding on probing <20% (Muhlemann & Son 1971) at the start of the study. Participants will undergo clinical and radiographic analysis of peri-implant tissues and prosthetic connections at the following intervals: up to 7 days after implant installation (Time 0), at the time of prosthesis installation (Time 1), 6 months after prosthesis installation (Time 2), and 1 to 5 years after prosthesis installation (Times 3, 4, 5, 6, and 7, respectively). It is expected that this longitudinal study will lead to a better understanding of the factors influencing peri-implant bone loss and long-term success.

详细描述

Selection of Research Participants Patients treated in the Implant Dentistry specialization course at FO-UFF, who undergo implant dentistry planning and receive rehabilitative treatment with endosseous implants, will be invited to participate in the research, provided they meet the inclusion criteria.

  • Inclusion Criteria: Completion of surgical-prosthetic planning by the Implant Dentistry Clinic team at UFF, including osseointegrated implants and prosthetic components manufactured by SIN Implant System (São Paulo, Brazil); agreement to sign the informed consent form and willingness to be monitored for a period of 5 years, following the previously established course clinic protocol; systemically healthy patients who do not use antiresorptive and antiangiogenic drugs; patients with a plaque index <20% (Ainamo & Bay 1975) and bleeding on probing <20% (Muhlemann & Son 1971) at the start of the study.
  • Exclusion Criteria: Patients undergoing rehabilitation with implants from different systems and/or not performed at the UFF Implant Dentistry specialization clinic; patients unable to attend radiographic follow-up over 5 years; patients unable to respond to questions in clinical analysis and satisfaction survey forms; presence of systemic conditions preventing the surgical procedure for dental implant installation; presence of metabolic bone disorders; presence of untreated or uncontrolled chronic or aggressive periodontitis; pregnant or lactating women.

Based on these criteria, a total of 148 research participants will be included and followed for 72 months (6 years).

Installation of Osseointegrated Implants Research participants will undergo clinical and prosthetic planning (reverse planning), including clinical-tomographic examinations and complementary tests, such as biochemical blood analysis and, when necessary, surgical risk assessment, according to the UFF Implant Dentistry specialization course protocol. The surgical technique, type of implant installed, and selected prosthetic components will follow the manufacturer's recommendations (SIN Implant System, São Paulo, Brazil), always considering treatment options for optimal patient rehabilitation.

1.1. Clinical Evaluation The clinical evaluation will include detailed anamnesis, assessment of participant satisfaction, peri-implant clinical examination, and evaluation of prosthetic connections over 5 years (Appendix 2). Clinical data will be updated throughout the study evaluations (Table 1) to analyze possible changes in satisfaction or peri-implant tissue condition.

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

  • Completion of surgical-prosthetic planning by the Implant Dentistry Clinic team at UFF, including osseointegrated implants and prosthetic components manufactured by SIN Implant System (São Paulo, Brazil); agreement to sign the informed consent form and willingness to be monitored for a period of 5 years, following the previously established course clinic protocol; systemically healthy patients who do not use antiresorptive and antiangiogenic drugs; patients with a plaque index <20% (Ainamo & Bay 1975) and bleeding on probing <20% (Muhlemann & Son 1971) at the start of the study.

排除标准

  • Patients undergoing rehabilitation with implants from different systems and/or not performed at the UFF Implant Dentistry specialization clinic; patients unable to attend radiographic follow-up over 5 years; patients unable to respond to questions in clinical analysis and satisfaction survey forms; presence of systemic conditions preventing the surgical procedure for dental implant installation; presence of metabolic bone disorders; presence of untreated or uncontrolled chronic or aggressive periodontitis; pregnant or lactating women.

结局指标

主要结局

PRIMARY IMPLANT STABILITY

时间窗: From enrollment to the end of treatment at 6 months

Data on the clinical and radiographic characteristics of the different installed implants and the short-term stability of their prosthetic connections will be obtained. Over the years of evaluation, there may be better recognition of the factors influencing peri-implant bone loss and long-term success.

次要结局

未报告次要终点

研究者

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

Priscila Ladeira Casado

PhD in Morphology , Professor and Researcher at the Universidade Federal Fluminense

Universidade Federal Fluminense

研究点 (2)

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