A Prospective Clinical Follow-up Study of Straight and Tapered Dental Implants Placed in the Anterior Maxilla
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Implant Survival
研究概览
简要总结
This prospective study aims to evaluate 5-year clinical, radiographic, and patient-reported outcomes of implant-supported crowns and bridges placed on Neoss implants (ProActive Straight and Tapered) in the anterior maxilla (region 13 - 23). The study is conducted at Brånemarkkliniken, Public Dental Service, Västra Götalandsregionen, Sweden. While the treatment involves established methods and CE-marked devices, long-term data for this specific indication are limited.
详细描述
The purpose of this study is to conduct a 5-year follow-up of implant-supported crowns and bridges placed on Neoss implants (ProActive Straight and Tapered) in the anterior maxilla (region 13 - 23).
This is a prospective, single-center clinical follow-up study evaluating implant-supported prosthetic restorations in the anterior maxilla. Eligible patients receiving crowns or bridges supported by Neoss implants (ProActive Straight and Tapered) will be followed for 5 years.
The treatment is based on established methods and CE-marked devices routinely used in clinical practice. However, long-term data for this specific indication are limited, and prospective follow-up is considered to be of clinical relevance.
Clinical, radiographic, digital, and patient-reported outcomes will be assessed at prosthetic delivery (baseline), and at 1-year and 5-year follow-ups. The study aims to evaluate the performance of Neoss implants (ProActive Straight and Tapered) as support for single crowns and bridges after 5 years, with respect to complications, function, aesthetics, and patient satisfaction.
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
- 否
入选标准
- •Signed informed consent to participate in the study. Adults ≥18 years of age requiring an implant-supported crown or bridge in the anterior maxilla (region 13-23).
- •No prior bone augmentation required at the implant site. The implant site must be free from signs of infection.
排除标准
- •Individuals under 18 years of age. Individuals unable to provide informed consent due to disease, mental disorder, impaired health status, or similar conditions.
- •Presence of systemic or local disease/condition contraindicating implant treatment.
- •Lack of availability for follow-up visits over the 5-year study period. Previous radiotherapy to the head, neck, or jaw region. Untreated or uncontrolled periodontitis and/or peri-implantitis. Use of immunosuppressive medication. Uncontrolled diabetes mellitus. Severe alcohol and/or substance abuse.
研究组 & 干预措施
Implant-Supported Crowns and Bridges on Neoss Implants (ProActive Straight and Tapered)
Participants will receive implant-supported crowns or bridges supported by Neoss implants (ProActive Straight and Tapered) placed in the anterior maxilla as part of routine clinical treatment. Prosthetic rehabilitation will be performed following standard clinical procedures, and participants will be followed for 5 years to assess clinical, radiographic, and patient-reported outcomes.
干预措施: Neoss Implant System (ProActive Straight and Tapered) (Device)
结局指标
主要结局
Implant Survival
时间窗: Baseline, 1 year, and 5 years
Absence of implant loss during the study period.
Change in marginal bone level around implants
时间窗: Baseline, 1 year, and 5 years
Change in marginal bone level around implants as assessed by radiographic evaluation using standardized, anonymized radiographs. Measurements will be performed by an independent examiner.
次要结局
- Peri-implant Soft Tissue Status and change(Baseline, 1 year, and 5 years)
- Individual Tooth-Related Pink Esthetic Score (PES)(Baseline, 1 year, and 5 years)
- Patient-Reported Outcomes(Baseline, 1 year, and 5 years)
- Incidence of Adverse Events(Throughout the 5-year study period)