Bovine Derived Xenograft in Combination With Autogenous Bone Chips Versus Xenograft Alone for the Augmentation of Bony Dehiscences Around Oral Implants: a Randomized, Controlled, Split-mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 主要终点
- Horizontal and vertical bone augmentation
研究概览
简要总结
This study will be an open, prospective, split-mouth, randomised controlled clinical trial. A total of 14 patients searching for oral implant treatment and where a GBR procedure is indicated per implant treatment will be enrolled.
All patients have to fulfill all of the inclusion criteria and none of the exclusion criteria. From all patients clinical photos will be taken.
Two sites within a patient will be randomly allocated to the 'autologous bone chips and DBBM or 'DBBM particles alone' group.
The study will be 1 year follow-up study comprising 9 visits
详细描述
A randomized controlled clinical trial (RCT) to compare the use of deproteinized bovine bone mineral (DBBM) in combination with autogenous bone chips versus a DBBM alone for the augmentation of bony dehiscence after dental implant placement
Objectives: 1. To test whether the use of DBBM is not inferior to the use of a combination of DBBM and autogenous bone chips for the filling of bony dehiscence around dental implants
- To test whether a digital impression technique can be used to measure guided bone regeneration in comparison to conventional measurement with a dental probe and to compare these observations with cone beam CT images
Study Design: Randomized, controlled, single center, split mouth study
Study Population: Partially edentulous male or female patients in need for oral implants for a fixed prosthetic implant supported rehabilitation and where a Guide Bone Regeneration (GBR) procedure is indicated during implant treatment
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 18 years,
- •in need of a solitary implant in quadrant 1 and 2 or quadrant 3 and 4 with simultaneous GBR procedure
- •presence of a pre-operative CBCT.
排除标准
- •patients with systemic diseases that could interfere with the healing
- •patients undergoing bisphosphonate treatment
- •patients who previously received radiation therapy of the jaws
- •patients that received a GBR procedure in the region of interest in the past.
研究组 & 干预措施
Augmentation with autologous bone + DBBM
A layer of autogenous bone chips was placed on the implant surface. On top of this a layer of DBBM (Bio-Oss™, Geistlich®, Wolhusen, Switserland) was placed, thereafter covered with a collagen membrane.
干预措施: Guided bone regeneration with or without autologous bone (Procedure)
Augmentation with DBBM
A layer of DBBM was placed on the implant surface and thereafter covered with a collagen membrane. Care was taken to make both augmentations as comparable as possible by weighting the used amount of graft material.
干预措施: Guided bone regeneration with or without autologous bone (Procedure)
结局指标
主要结局
Horizontal and vertical bone augmentation
时间窗: 16 weeks
The change of dimension was assessed comparing Cone Beam Computed Tomography scans (CBCT)
次要结局
- Success of grafting procedure as assessed by clinical interpretation(1 year)
- Marginal bone level alterations assessed on peri-apical radiographs using software (ImageJ)(1 year)
研究者
Wim Teughels
Clinical Professor
Universitaire Ziekenhuizen KU Leuven