Safety and Efficacy Evaluation of the Ivory Dentin Graft Device - Long Term Follow-Up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Related Adverse Events
研究概览
简要总结
long-term safety and performance of Ivory Dentin Graft. Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen-Os) for alveolar ridge preservation following tooth extraction.
详细描述
This clinical investigation is part of the post-market development process of the investigational device of Ivory Graft Ltd. in order to satisfactory validate the safety, tolerability and effectiveness of Ivory Dentin Graft as required by the sponsor's European Union (EU) notified body.
The clinical Investigation was conducted with the stated confirmation applying European regulations; International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines, ISO 14155:2011, and with a relevant subject population for the study objectives. Israeli Ministry of Health registration Number: 20173907.
The purpose of this investigation is to evaluate the safety, tolerability and effectiveness of Ivory Dentin Graft for long-term evaluations, compared to the active comparator, OsteoBiol-Gen-Os® graft, as a treatment for alveolar ridge preservation following tooth extraction.
Long term follow-up: from completion of visit 5 (implant placement) up to 5 years from bone grafting per subject (visits 6-9).
Study design: A prospective, randomized, semi double-blinded with blinded assessments clinical investigation, comparing between subjects grafted with Ivory Dentin Graft (Investigational group) and subjects grafted with OsteoBiol-Gen-Os® (comparator group)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Only the graft performing sub-investigator and the study coordinator are un-blinded to subjects allocation - semi double blinded study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patient 18 up to 80 years.
- •Patient requiring at least one implant placement following mandibular pre-molar or molar tooth extraction.
- •Alveolar mandibular ridge (empty socket):
- •Height: not less than 10 mm, from the gingival margin to the mandibular nerve canal - as seen in the screening CT scan.
- •Width: not less than 5 mm, from buccal to lingual cortical plates - as seen in the screening CT scan.
- •Ability to give informed consent for the study by patient or legal guardian.
- •Willingness to undergo 7 follow up visits: 1 week, 1, 4, 6 and 10 months, 2.5 years and 5 years following dental graft implantation, as well as unscheduled sick visits.
排除标准
- •Pregnancy (all women of childbearing age would be questioned and told by the consenting physician regarding that criteria).
- •Known or suspected hypersensitivity to the constituents of the bone graft material (for example porcine collagen)
- •Pathologies or conditions contraindicating surgery or presenting with active acute or chronic infections excluding periapical granuloma (for example osteomyelitis, sinusitis), uncontrolled diabetes
- •Immunologic disorders or autoimmune pathologies, in particular elderly
- •Serious bone diseases of endocrine aetiology
- •Serious disturbances of bone metabolism
- •Ongoing treatment with gluco- or mineralocorticoids, or with agents affecting calcium metabolism (e.g. calcitonin, bisphosphonates)
- •Irradiation therapy, chemotherapy or immunosuppressive therapy in the last 5 years
- •Malignancies
- •Severe Parafunction (bruxism and clenching)
- •Poor oral hygiene or active periodontitis
- •Heavy tobacco smoking habit (> 10 cigarettes per day)
研究组 & 干预措施
Experimental (Intervention)
干预措施: Ivory Dentin Graft (Device)
Active Comparator
干预措施: OsteoBiol Gen-Os (Device)
结局指标
主要结局
Number of Participants with Treatment-Related Adverse Events
时间窗: 5 years after grafting
through study completion
Success of implant placement in a rigid post grafting site
时间窗: 5 years after grafting
defined by dental implant survival
次要结局
未报告次要终点