Comparison of Customized Allogenic Versus Autogenous Bone Block Graft for Alveolar Ridge Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- ridge width gain in mm
研究概览
简要总结
The aim of this study is to determine whether jawbone augmentations using allogeneic and autogenous bone blocks lead to comparable three-dimensional clinical and radiological outcomes.
In addition, the study seeks to investigate whether there are differences regarding safety, biocompatibility, complications, and PROMs.
Furthermore, it aims to clarify whether differences exist between the two groups with respect to implant condition (one year after implantation and during annual follow-ups for up to five years).
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
- 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
- •1-4 missing teeth that need to be replaced with dental implants
- •Bone ridge width insufficient for dental implant placement; <5 mm of width as measured in a cone beam computed tomography at the ideal prosthetic position
- •Medically healthy with no known allergies to antibiotics
- •Non-smoker or light smoker (< 10) or previous smoker who had quit for 5 years or more
- •Periodontal health, as confirmed by clinical examination (Full mouth bleeding score and full mouth plaque score < 25%) and at least one neighboring natural tooth to the defect site(s)
- •Age of 18 or above
排除标准
- •All contraindications against implant treatment or augmentative procedures (e.g., advanced systemic diseases, corticosteroid medication, immunodeficiency, pregnancy, intention to become pregnant, breastfeeding, lack of safe contraception)
- •Treatments or diseases that may have an effect on bone turnover or the bone itself or non-mineralized tissue metabolism (e.g., bisphosphonates or local radiotherapy, skeletal immaturity)
- •Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone diseases
- •Any active malignancy or patient undergoing treatment for a malignancy Study protocol: IndiALLO Version 4/19.03.2025 Page 9 von 32
- •Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product
- •Persistent compartment syndrome or neurovascular residua of compartment syndrome
研究组 & 干预措施
individualized allogenic bone block alveolar ridge augmentation
干预措施: allogenic bone block augmentation (Procedure)
autologous bone
干预措施: Alveolar socket preservation with graft and flap surgery (Procedure)
结局指标
主要结局
ridge width gain in mm
时间窗: at screening after augementation (= day 0) 180 days past augmentation (=implantation) 1 year after 2nd stage surgery 2 years after 2nd stage surgery 3 years after 2nd stage surgery 4 years after 2nd stage surgery 5 years after 2nd stage surgery
* Clinical bone ridge width gain * Radiological bone ridge width gain
次要结局
未报告次要终点