Remodeling of Prefabricated Conventional and CAD/CAM Custom Fabricated Allograft Blocks for Bone Augmentation - Volumetric Analysis and Dental Implant Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Bone graft volume (Vol, in mm³)
研究概览
简要总结
To rehabilitate patients after the loss of their own teeth, dental implants are nowadays the therapy of choice if the indication is suitable. In order to successfully place implants in the patient's jaw, a sufficient supply of bone in vertical and horizontal dimensions is necessary. Human bone is generally always in the process of reconstruction and changes over time. If there is not enough substance left for rehabilitation with implants due to previous degradation of the alveolar bone, bone augmentation can be performed. For this purpose, mainly autogenous, xenogenic or allogenic bone material is used.
Bone augmentation using allografts shows satisfactory results in clinical use and has advantages such as elimination of morbidity associated with autogenous bone graft harvesting. In addition to the use of conventional and prefabricated graft blocks, it is now possible to produce individual allogeneic bone blocks using computer-aided design based on the patient's radiological data. After this bone has been placed in the patient, it can be restored with implants after a healing phase of about 6 months.
In order to make the treatment as predictable as possible, it is crucial to know how a bone augmentation changes over time and whether bone remodelling or resorption occurs. How allogeneic bone blocks behave with regard to their stability and treatment success has already been investigated in some studies, but to date there is no study that deals with the difference between prefabricated, conventional and individually manufactured CAD/CAM allogeneic bone blocks.
By retrospectively analysing existing clinical data, the aim is to compare how the two methods, prefabricated bone blocks and CAD/CAM-fabricated bone blocks, perform during the healing phase.
A virtual volume analysis method of 3D digital imaging data (cone beam computed tomography scans) will be performed, which allows not only linear punctual evaluation but also area and volumetric analysis. Furthermore, the in the grafts inserted dental implants will be examined in terms of survival rate, complication rate and marginal bone loss by evaluation of the available follow-up records of up to 12 years.
详细描述
A clinical retrospective cohort study is planned in a non-invasive, observational study design.
The study will be conducted at a single university centre: the Department of Department of Stomatology (Periodontology), Faculty of Dentistry, University of Santiago de Compostela, Spain.
The study will be conducted in the following steps:
- Identification of the patient population:
The cohort for the retrospective study will be filtered from the patient data of the Department of Stomatology (Periodontology) of the University of Santiago de Compostela. Data from all patients who have received one of the following two treatments in the last 12 years will be selected and examined:
- Group A: horizontal and/or vertical augmentation of Puros® allogeneic bone graft material (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; type: conventional prefabricated bone blocks.
- Group B: horizontal and/or vertical augmentation of allogeneic bone graft material Puros® (Zimmer Biomet, Winterthur, Switzerland) in the upper and/or lower jaw; Type: individually planned, CAD/CAM-produced bone blocks
- Data extraction:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Treated with the defined allogeneic bone substitute material
- •Received the defined standardized intervention
- •Number of missing teeth in the bone defect region ≥ 3
- •3 CBCT scans recorded and available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)
排除标准
- •Treated with a different bone substitute material than the one defined for investigation
- •Received an other intervention than the defined standardized procedure
- •Number of missing teeth in the bone defect region < 3
- •One of the following CBCT scans not available: baseline before surgery (t=0), after graft surgery (t=1) and 6 months after surgery (t=2)
结局指标
主要结局
Bone graft volume (Vol, in mm³)
时间窗: t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline
Mean bone graft volume within the region of interest, measured in STL models derived from CBCT scans after the grafting procedure (t=1) and at 6 months follow-up (t=2) from baseline (t=0)
次要结局
- Mean linear distance (in mm)(t=1 directy after intervention, t=2 6 months after intervention compared to t=0 baseline)
- Mean marginal bone loss (in mm)(Maximum available follow-up period: from the beginning of the retrospective data analysis period, starting with the radiograph after implant loading until the last available follow-up radiograph; up to a maximum of 11 years, individually for each patient)
- Implant survival rate(Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient)
- Implant complication rate (biological and technical)(Maximum available follow-up period: from the beginning of the retrospective data analysis, starting after implant insertion until the last available follow-up patient record; up to a maximum of 11 years, individually for each patient)
研究者
Juan Blanco Carrión
Prof. Dr. Juan Blanco Carrión
University of Santiago de Compostela