A Phase I/II Double-Blind Randomised Controlled Clinical Trial To Study The Safety and Efficacy Of A Novel Regenerative Treatment Of Infrabony Periodontal Defects Using Autologous Alveolar Bone-Marrow Mesenchymal Stem Cells (aBM-MSCs).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- A reduction in the distance in mm from the bottom of the periodontal pocket to the cementoenamel junction using a manual probe (Hu-Friedy XP-23/QW, Hu-Friedy, Chicago, IL, USA) with 20-25g of pressure by a single calibrated examiner.
研究概览
简要总结
Systemically healthy periodontitis patients are recruited from new referrals to the Department of Periodontology and Biology of Implants, AUTh. After completion of non-surgical periodontal treatment those subjects who have at least one interdental osseous defect with probing pocket depth and clinical attachment level of ≥ 6mm and an intrabony component of ≥ 3mm with no endodontic or furcation involvement are randomly allocated into one of the three treatment groups. Group A receives regenerative treatment using autologous bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with fibrin glue; in Group B, a collagen fleece enriched with fibrin glue devoid of stem cells fills the osseous defect; Group C receives open flap debridement retaining the soft wall of the defect. Thereafter, subjects are followed for 12 months and are repeatedly assessed based on clinical, radiographic, immunological and microbiological parameters.
In a series of cases, tissue engineering in a similar manner to Group A will be applied to treat isolated periodontal interdental defects, in combination with the novel "closed surgical technique".
详细描述
Aims & Objectives The present study describes a novel method to regenerate periodontal tissues in periodontal infrabony defects using autologous BM-MSCs, free of animal derived reagents, produced in clean room facilities enriched with autologous fibrin glue and seeded into commercially available collagen scaffolds (collagen fleece).
Primary objective This study aims to assess the efficacy of a novel regenerative treatment of periodontal infrabony defects using a biocomplex of BM-MSCs/fibrin glue/collagen fleece, as compared to a cell-free grafting substitute of fibrin glue/collagen fleece and to a control treatment approach of open flap debridement with no adjunctive use of grafting materials.
Secondary Objectives
- To document the stability of the enhanced treatment outcome and to continue to assess the safety and effectiveness of BM-MSCs transplantation as compared to the control treatment of open flap debridement over the study period.
- Determine the immunological and microbiological profiles of the participants throughout the study period in an attempt to understand local and systemic effects of the transplantation of BM-MSCs in chronically diseased sites, such as the infrabony periodontal defect. In addition, the healing response to treatment will be determined throughout the observation period (baseline to 12-months).
Study Design
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participant, care provider, investigator/outcome assessor is not aware of the treatment modality
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Following non-surgical periodontal treatment, advanced chronic periodontitis patients, who are able to maintain plaque scores of less than 25% and have at least one deep infrabony defect with PPD and CAL of ≥ 6mm and an infrabony component of ≥ 3mm with no endodontic or furcation involvement as detected on the radiographs will be scheduled for surgery and will be followed for 12 months.
排除标准
- •Exclusion criteria: poorly controlled systemic disease, heavy smoking (>20cigs/day), drug induced gingival hyperplasia, bisphosphonate medication, anti-inflammatory drugs, bone metabolic diseases or disorders that compromise wound healing, immunosuppressive therapy or radiation, alcohol intake, drug abuse over the past year, significant concurrent illness, pregnancy/lactation, poor compliance during the initial phase of treatment, compromised oral hygiene (PI ≥25%).
结局指标
主要结局
A reduction in the distance in mm from the bottom of the periodontal pocket to the cementoenamel junction using a manual probe (Hu-Friedy XP-23/QW, Hu-Friedy, Chicago, IL, USA) with 20-25g of pressure by a single calibrated examiner.
时间窗: up to 12- months
Clinical data (gain in clinical attachment level (CAL))
次要结局
- A reduction in the distance in mm between the gingival margin and the bottom of the defect using a manual periodontal probe (Hu-Friedy XP-23/QW) by a single calibrated examiner.(up to 12-months (baseline, 6-, 9-, 12- months))
研究者
Danae A. Apatzidou
Assistant Professor
Aristotle University Of Thessaloniki