NL-OMON51997已完成不适用
A randomized prospective clinical trial comparing OsteoActivator-P coated membranes vs Collagen Membrane-P uncoated for accelerated localized alveolar ridge preservation. - OsteoActivator-P for accelerated localized alveolar ridge preservation.
Osteo-Pharma.B.V.0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Males and females, aged >=18 years.
- •Patient has signed informed consent.
- •Patients with a ruinous dentition (including the canines) in the lower jaw in
- •need of extractions of all teeth of the mandible.
- •Patients in need of a total dental prosthesis in the lower jaw.
- •Patients that want an implant-based denture in the lower jaw.
- •Bone width of at least 7mm
- •Bone height beneath the root-point of the canines at least 10mm
排除标准
- •Absence of the lower canines
- •Concomitant Medication: prescription or nonprescription drugs affecting
- •bone-metabolism, including corticosteroids, gonadotropins, sex steroids (not:
- •contraceptive medication), bisphosphonates, denosumab, parathyroid hormone and
- •calcitonin.
- •History of radiotherapy in the head/neck region
- •Poor oral hygiene
- •Women who are pregnant or breastfeeding
- •Compromised immune system (e.g. uncontrolled diabetis) or unstable bleeding
- •Patients with ASA classification of III or worse
- •Local infection at the site of implantation
- •History of previous ridge augmentation/preservation at the site of interest
- •History of oral cancer or radiation of the oral cavity.
- •Current malignancy
- •Unresolved oral pathologies
- •Patient does not give permission for implantation of porcine membrane.
- •Highly atrophic mandible (Cawood classification V or higher)
- •Known allergy to collagen.
- •Heavy smoking (> 20 cigarettes/day).
研究者
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