Use of OsteoBiol® Lamina® Soft and Different Collagen-based Graft Materials in Bone Regeneration: A Pilot Prospective Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This prospective controlled clinical pilot study will compare the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites with buccal bone deficiency, using a collagenated porcine cortical bone lamina as a barrier membrane.
A total of 21 patients requiring implant-supported rehabilitation associated with bone regeneration will be enrolled, for a total of 40 implants. In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft, while in the control group a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a semi-rigid collagenated cortical bone lamina will be applied and stabilized to contain the graft material and maintain space for regeneration.
The primary objective of the study will be to evaluate volumetric bone changes over time using cone-beam computed tomography imaging, comparing baseline and follow-up scans. Secondary outcomes will include linear measurements of bone gain at different levels around the implant site.
The study will investigate whether collagenated xenografts alone can provide comparable clinical and radiographic outcomes to combined grafting approaches including autologous bone, while potentially reducing patient morbidity associated with bone harvesting.
详细描述
Severe alveolar ridge resorption following tooth extraction may result in insufficient bone width and compromised anatomical conditions for implant placement, particularly in sites with buccal cortical plate deficiency. In such cases, guided bone regeneration (GBR) procedures will be required to restore adequate bone volume and allow for prosthetically driven implant rehabilitation.
A wide range of grafting materials will be used in clinical practice for bone regeneration, including autologous bone, allogeneic and xenogeneic biomaterials, as well as synthetic substitutes. Among these, xenogeneic collagenated grafts will be increasingly adopted due to their favorable biological properties, including clot stabilization, facilitation of early cellular infiltration, and promotion of angiogenesis. However, their relatively rapid remodeling rate may influence the final volumetric stability of the regenerated bone.
Barrier membranes will play a crucial role in GBR procedures by preventing soft tissue invasion and maintaining space for bone regeneration. Recently, collagenated porcine cortical bone laminae will be introduced as semi-rigid membranes combining the advantages of mechanical stability and biocompatibility. When properly stabilized, these devices will act as containment structures for graft materials, potentially improving regenerative outcomes.
The present study will be designed as a prospective controlled clinical trial to evaluate the effectiveness of two different grafting strategies for horizontal bone regeneration in healed post-extraction sites presenting buccal bone deficiency. Patients requiring implant-supported rehabilitation associated with bone augmentation procedures will be consecutively enrolled and allocated to one of two treatment groups.
In the test group, bone defects will be grafted using a collagenated cortico-cancellous sticky xenograft. In the control group, a mixture of hydroxyapatite-based xenograft and autologous bone in a 1:1 ratio will be used. In both groups, a collagenated porcine cortical bone lamina will be applied as a barrier membrane and stabilized using fixation pins to ensure space maintenance and graft containment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healed type II post-extraction sockets according to the Elian classification
- •Age between 18 and 80 years
- •Good periodontal control, defined as treated periodontitis with plaque index <25% and bleeding on probing <25%
- •ASA I or ASA II systemic status
- •Ability and willingness to provide written informed consent
- •Ability and willingness to attend scheduled follow-up visits
排除标准
- •Smoking more than 10 cigarettes per day
- •Active oral infections
- •Mucosal diseases, including erosive lichen planus
- •History of radiotherapy in the head and neck region
- •Systemic diseases affecting bone metabolism or contraindicating oral surgery
- •Non-compliance or inability to complete follow-up
- •Extraction sockets with intact bone walls
研究者
Nicola Alberto Valente, DDS, MS, PhD
Associate Professor
University of Cagliari