Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Bone volume obtained
研究概览
简要总结
Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation. However, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. Several biomaterials have been used as a replacement of the autogenous bone. Viral-inactivated bone allograft powder is an alternative that has proven efficacy and tolerance. This study aims to assess the non-inferiority of viral-inactivated allogeneic bone paste compared to a viral-inactivated cortico-cancellous allogenic bone powder in achieving the ideal bone volume.
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
Statistician will also perform trial analyses with treatment masking
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
- •Patient aged ≥ 18 years old
- •Patient able to read, understand and give written consent to participate in the study
- •Patient affiliated with a social security system or beneficiary of such a system
- •Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume
- •Presence of a bone deficit requiring horizontal and / or vertical bone augmentation (stage 4 or 5 of the Benic and Hammerle classification) treated by GBR for delayed placement of up to 4 dental implants
- •Possibility of acquisition by CBCT for the required protocol visits
排除标准
- •General contraindication to bone graft and implant surgery
- •Pregnant woman or planned pregnancy during the study period or breast-feeding woman;
- •Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material
- •Patient who received less than 3 months ago a CBCT acquisition at the operative site
- •Patient simultaneously requiring more than one GBR augmentation in the same quadrant
- •Patient with signs of local infection at the targeted graft site
- •Systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes)
- •Use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing
- •Patient presenting a dental plaque objectified by an oral examination (Loe SILNESS ≥ 2 on more than 50% of the dental surfaces)
- •Patient smoker of more than 10 cigarettes a day
- •Any other condition that, in the investigator's opinion, would be detrimental to the safety of the patient or fail to meet the requirements of the protocol
结局指标
主要结局
Bone volume obtained
时间窗: 4 to 6 months post-bone grafting
The primary endpoint is binary in nature (yes / no) and assessed radiographically by the CBCT: To assess, 4 to 6 months post-transplant, if the bone volume obtained at the time of implant placement corresponds to the desired bone volume before the transplant. Measured by an independent Evaluator, blind to the treatment received.
次要结局
- Duration of surgery(immediate post-operative)
- Ease of manipulation(immediate post-bone grafting)
- Absolute gain in bone volume(4 months post-bone grafting)
- Primary osteointegration (implants stability)(4 months post-bone grafting)
- Peri-implant marginal bone height(4 months post-bone grafting)
- Survivorship of the implant(3-4 months post-implant)
- Need for a new bone augmentation simultaneously with implant placement(4 to 6 months post-bone grafting (implant placement))
- Insufficient primary stability of the implant(4 to 6 months post-bone grafting (implant placement) and 3-4 months post-implant)
- Occurrence of complications related to the transplant(7-10 months post-bone grafting)
- Nature of possible complications or a thematic grouping in the inter-group comparison(7-10 months post-bone grafting)