Safety and Efficacy Evaluation of the Ivory Dentin Graft Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Amount of new bone formation
研究概览
简要总结
Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen Os) for alveolar ridge preservation following tooth extraction.
The non-inferiority endpoints will be achieved if the competitor treatment group will not be statistically better than the Ivory Graft treatment.
详细描述
Device Description - Investigational Medicinal Product Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 900 μm porous particles of hydroxyapatite which retain the natural form of the source porcine dentin.
Ivory Dentin Graft is intended to be used as a bone graft material for the repair or augmentation of bone defects in dental procedures.
OsteoBiol Gen Os. - Comparator control device A natural replicate of autologous bone, Gen-Os® conserves the same intimate structures (matrix and porous form) and presents a highly osteoconductive properties. Gen-Os® is gradually resorbable and provides support in bone neoformation helping to preserve the original graft shape and volume.
Study Design: The Ivory Dentin Graft study is a prospective, randomized, semi double blinded with blinded assessments study comparing patients grafted with Ivory Dentin Graft (Investigational group) and patients grafted with OsteoBiol Gen Os (comparator group) for alveolar ridge preservation following tooth extraction.
Study Population and Justification: A total of 44 adult patients in 2 study groups scheduled to undergo at least one dental implant placement of mandibular premolar or molar are planned to be enrolled. The patients will be randomized into two treatment groups: One group is to be grafted with Ivory Dentin Graft while the second group will be grafted with OsteoBiol Gen Os, randomization ratio of 1:1 between the experimental and control 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 will be un-blinded to the patient allocation. All efforts and measures would be taken by the study team to keep the patient and blinded assessors blinded of allocation (allocation of each extracted site) - semi double blinded study.
Shipment tubes for biopsy (primary endpoint) are labelled with the appropriate blinded coded specimens.
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 all follow up visits, as well as unscheduled sick visits.
排除标准
- •Pregnancy (all women of child-bearing 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 auto-immune 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
Ivory Dentin Graft (Ivory Graft Ltd.)
Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 1200 μm porous particles or granules of hydroxyapatite which retain the natural form of the source porcine dentin and also the natural protein matrix which consists largely of porcine collagen.
This type of Graft Matrix will be administered as the intervention.
干预措施: Graft Matrix (Device)
OsteoBiol Gen-Os ® (Tecnoss)
A natural replicate of autologous bone, Gen-Os® conserves the same intimate structures (matrix and porous form) and presents a highly osteoconductive properties.
It is biocompatible and bioavailable, as recognized by tests made according to the ISO 10993 method conducted at Eurofins Biolab.
This type of Graft Matrix will be administered as the intervention.
干预措施: Graft Matrix (Device)
结局指标
主要结局
Amount of new bone formation
时间窗: 4 months after grafting
Mean area of mineralized and non-mineralized tissue in alveolar bone core biopsies - "woven bone" (Ratio 0-100%)
Bone-Graft material integration score to host bone in the alveolar bone core
时间窗: 4 months after grafting
1 - poor: no signs of new bone-to-graft interface visible, 2 - intermediate: minimal and focal signs of new- bone-to-graft interface visible, 3 - good: abundant new bone-to-graft interface visible.
次要结局
- Alveolar bone radiodensity (Hounsfield scale)(4 months after bone grafting)
- Alveolar bone strength(4 months after grafting)
- Changes from baseline in alveolar bone width (horizontal bone gain or loss)(4 months after bone grafting)
- Success of dental implant placement in a rigid post bone grafting site(4 months after bone grafting)
- Changes from baseline in alveolar bone height (depth reduction)(4 months after bone grafting)