NCT01960361已完成4 期
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of ICE Implant System Over 24 Months, for Patients With Tooth Loss Requiring up to 4 Implants, in Staged Loading Protocol
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Cumulative Survival Rate
研究概览
简要总结
The current prospective clinical study's aim is to determine ABT's ICE implant survival rate, crestal interproximal bone resorption during 24 months post implant insertion and to assimilate the drilling sequence during the clinical use of ICE implants.
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
- •Men and women over the age of 18 years who need implantation of 1-4 implants.
- •Patients who are able to understand the requirements of the study, and are willing and able to comply with its instructions and schedules.
- •Patients who had provided written informed consent to participate in the study prior to any study procedure.
- •Patients in general good health in the opinion of the principal investigator as determined by medical history and oral examination.
排除标准
- •Immediate loaded implants.
- •Treatment with anticoagulant drugs (INR under 1.8) or bisphosphonates.
- •Treatment with anticonvulsants drugs.
- •Untreated Periodontal disease and inability of the patient to maintain reasonable oral hygiene according to study requirements.
- •Patients with history of alcohol, narcotics or drug abuse.
- •Patients under steroid therapy.
- •Patients receiving radiotherapy, chemotherapy or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years.
- •Patients through at anytime received radiotherapy to the head and neck region will be excluded anyway.
- •Metabolic bone disorders and/or bone augmentation.
- •Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia.
- •Degenerative diseases.
- •Osteoradionecrosis.
- •Renal failure.
- •Organ transplant recipients.
- •HIV positive.
- •Malignant diseases.
- •Diseases that compromise the immune system.
- •Unbalanced diabetes mellitus. (HbA1c above 6.5)
- •Psychotic diseases.
- •Hypersensitivity to one of the components of the implant in general and titanium in particular.
- •Women who are pregnant or lactating.
- •Lack of patient cooperation.
- •Uncontrolled endocrine diseases.
- •Any systemic condition that is unbalanced and therefore precludes surgical procedures.
- •Parafunctional habits.- e.g Bruxism.
- •Temporomandibular joint disease.
- •Various pathologies of the oral mucosa for example: Benign mucous pemphigoid, desquamative ginigivitis, erosive lichen planus ,malignancy of oral cavity, bolus erosive diseases of the oral mucosa.
结局指标
主要结局
Cumulative Survival Rate
时间窗: 24 MONTHS
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
4 期
A Multi-center Study to Evaluate Bone Loss, Survival Rate and Stability of SPI ImplantImplant Clinical SurvivalDental Implant Bone LossNCT02367261Alpha - Bio Tec Ltd.88
已完成
不适用
Evaluation of Peri Implant Bone Loss of Immediately Versus Conventionally Loaded Implants With a Single ProsthesisPeriodontal Bone LossNCT02416700Mônica Nogueira Pigozzo17
终止
不适用
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage SurgeryJaw, EdentulousNCT00748397Dentsply Sirona Implants and Consumables54
招募中
不适用
Knee Related Subchondral Bone Lesions Treated With IOBPSubchondral CystNCT05314608Arthrex, Inc.100
进行中（未招募）
不适用
G7 BiSpherical Acetabular Shell PMCF StudyNoninflammatory Degenerative Joint DiseaseCorrection of Functional DeformityNon-Union FractureFemoral Neck FracturesTrochanteric FracturesRheumatoid ArthritisOsteoarthritisAvascular NecrosisNCT03266874Zimmer Biomet160