Observational Study Evaluating Safety and Performance of Dental Implant Systems (5 Implant Ranges: IDAll, IDBio, IDCam, IDMax, ID3; 3 Types of Prosthetic Parts: Sealed, Screw-retained and Removable) in Subjects Followed During 18 Month
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Osteointegration achieved between 2 and 6 months evaluated by clinical examination
研究概览
简要总结
Post-Market Clinical Follow-Up to evaluate the safety and performance of IDI dental implant systems : confirmation of osseointegration of the different implants at the loading visit (between 2 and 6 months after surgery).
详细描述
The aim of the present study is to carry out post-marketing clinical monitoring of the medical device used in accordance with the instructions for use according to a medical strategy intended for the person who is suitable for this research which is not fixed in advance by an investigation plan and is part of the current practice of the surgeon.
This is a comparative, prospective, multicenter observational study
The osteointegration reached between 2 and 6 months after surgery will be evaluated by clinical and radiological examinations:
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
- 否
入选标准
- •Subject receiving an insertion of an aesthetic and functional oral prosthesis on IDI implant systems (IDAll, IDBio, IDCam, IDMax or ID3) for at least one of the following indications:
- •Single, partial or complete edentulousness
- •Stabilization of a removable prosthesis
- •Subject having received an information sheet on the study and having indicated their non-objection before starting the procedures specific to the protocol.
- •ASA score (American Society of Anesthesiologists) <
- •If a recent extraction has been performed at the site of the implantation area, the healing period should be at least 2 months.
- •Sufficient bone volume (minimum 4mm) to accommodate dental implants.
排除标准
- •Pregnant or breastfeeding woman.
- •Inability of the subject to maintain reasonable oral hygiene in accordance with study requirements.
- •Parafunctional habits, such as bruxism or temporomandibular joint disease.
- •Different pathologies of the oral mucosa such as: benign mucous pemphigoid, desquamative gingivitis, malignant tumor of the oral cavity, bolus erosive diseases of the oral mucosa.
- •Disorders of bone metabolism.
- •Untreated, unmanaged caries and / or periodontal disease.
- •Need for simultaneous bone grafting and / or sinus lift in the intended implant area.
- •Medical history making insertion of the implant unfavorable.
- •Lack of cooperation. Subject may not comply with study procedures.
- •Heavy use of tobacco (more than 10 cigarettes per day), drugs and / or alcohol.
- •Treatment with bisphosphonates, steroids or anticonvulsants.
- •Unbalanced diabetes.
- •Subject receiving radiotherapy, chemotherapy or any other immunosuppressive treatment. Subjects who received radiation therapy to the head and neck area at any time should not be included.
- •Congenital or acquired (HIV positive) diseases that compromise the immune system.
- •Uncontrolled bleeding disorders such as: haemophilia, thrombocytopenia, granulocytopenia.
- •Renal failure.
- •Organ transplant recipient.
- •Malignant diseases.
- •Psychotic illnesses.
- •Hypersensitivity to one of the components of the implant in general and to titanium in particular. It is the surgeon's responsibility to ensure that the subject does not have known allergies to any of the components of the material listed on the product label.
- •Sports or physical activities including violent shocks.
结局指标
主要结局
Osteointegration achieved between 2 and 6 months evaluated by clinical examination
时间窗: between 2 and 6 months after the surgery (dental implantation)
Measurement of the stability index of the implant with OSSEO100
Osteointegration achieved between 2 and 6 months evaluated by radiological examination
时间窗: between 2 and 6 months after the surgery (dental implantation)
Measurement of the bone loss
次要结局
未报告次要终点