Prospective Case Series Study of Neodent Implantable Devices of GM Zygomatic Line
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Neodent
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Implant success rate
研究概览
简要总结
GM Zygomatic implant is intended to be surgically placed in the posterior region of the maxilla and zygoma. It is indicated for multiple prostheses in case of severe resorption in the maxilla and total edentulism (situations in which the installation of convectional implants is contraindicated).
The objective of the study is to confirm the long-term safety and clinical performance of GM Zygomatic implants and GM Zygomatic abutments in daily dental practice setting, by means of a prospective collection of clinical data concerning the success and survival rates of these devices.
Devices will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the instructions for use (IFU). Ten patients will be followed for 36 months and monitored for Adverse Events by the Investigators until the last protocol-related procedure of a patient is completed.
详细描述
The study protocol was reviewed and approved by an Ethics Committee (CE) in Brazil.
GM Zygomatic implants present an optimized design with adapted treatment protocol, allowing for treatment of patients with severely resorbed maxilla and complete edentulism in which conventional implants placement is contraindicated.
The objective of the study is to confirm the long-term safety and clinical performance of implants and abutments of GM Zygomatic System in a daily dental practice setting, by means of a prospective collection of clinical data in a study using these devices.
Additionally, from the collected data, the study aims to identify previously unknown side-effects and monitor the known side-effects and contraindications stated on the Instructions for Use with the intent to verify that the intended purpose is adequate for all Neodent products involved in the procedure that come into contact with the patient.
The sample will be prospectively selected and will consist of 10 patients with atrophic edentulous maxillae, for whom the responsible surgeon elects the rehabilitation by means of placement of zygomatic implants as having the best risk-benefit ratio for the patient (e.g., shorter treatment time and lower biological cost than the associated with reconstructive surgeries for the insertion of conventional implants). Informed consent in writing will be obtained from each patient participating in the study prior to any study-related procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •18 years of age or more;
- •Opposing dentition (natural teeth or teeth/implant-supported fixed restorations).
排除标准
- •Symptomatology related to the facial sinuses (maxillary sinusitis, polyps or any other sinus pathologies);
- •Unfavorable maxillary relations;
- •Signs of allergy or hypersensitivity to the chemical ingredients of the material: titanium;
- •Presence of acute inflammatory or infectious processes in live tissue;
- •Unsuitable bone volume and/or quality;
- •Systemic complications or diseases such as bone metabolism disorders, blood clotting disorders, unsuitable healing capacity, incomplete jawbone growth, uncooperative and not motivated patient, abuse of drugs or alcohol, psychosis, prolonged functional disorders which resist any treatment with medications, xerostomia, weakened immunological system, diseases which require the use of steroids, endocrine diseases, insufficient oral hygiene, and pregnancy.
- •Additionally, subjects will be excluded if they present systemic complications that may expose them to an eventual surgical risk if submitted to surgery under general anesthesia or under local anesthesia and sedation (decompensated diabetics, immunosuppressed, patients who were submitted to radiotherapy and chemotherapy less than 4 years or who had a heart attack less than 1 year previously, patients with clinical signs and/or symptoms of sinusitis and congestion and/or nasal secretion.
结局指标
主要结局
Implant success rate
时间窗: 36 months after implant placement.
Evaluation of implant success will be assessed based on the criteria by Byser et al (1990).
Implant survival rate
时间窗: 36 months after implant placement.
Implant survival will be defined as no loss of the implant at each follow-up.
次要结局
- Adverse events related to the implant.(Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.)
- Implant survival rate(6, 12, and 24 months after implant placement.)
- Implant success rate(6, 12, and 24 months after implant placement.)
- Clinician Satisfaction(Immediately after implant placement, 12, 24, and 36 months after implant placement.)
- Prosthetic survival rate(12, 24, and 36 months after implant placement.)
- Prosthetic success rate(12, 24, and 36 months after implant placement.)
- Patient Satisfaction(Before implant placement and 6, 12, 24, and 36 months after implant placement.)
- Adverse events related to the prosthesis.(Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.)
- Adverse events related to the oral health(Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.)
- Adverse events related to the surgery.(Immediately after implant placement, 6, 12, 24, and 36 months after implant placement.)