Preservation of Alveolar Crestal Bone From Implant Placement to Implant Exposure Using Autologous Alveolar Bone-Marrow Derived Mesenchymal Stem Cells (aBM-MSCs)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- A reduction in the marginal bone levels
研究概览
简要总结
Systemically healthy volunteers with no active periodontal disease are recruited from referrals to the Dept. of Preventive Dentistry, Periodontology and Biology of Implants, Aristotle Univ of Thessaloniki for implant therapy. After signing a consent form, participants will be randomized into two treatment groups. Group-A (NA=10) will receive crestal placement of implants following a two-stage protocol in combination with a biocomplex comprising autologous alveolar bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with autologous fibrin glue. In Group-B (NB=10) implants are placed on the alveolar crest following a two-stage protocol and the manufacturer's guidelines. Intra-surgical clinical and radiographic assessments are performed at the time of implant placement (T0) and at the two-stage surgery (T1). Changes in mucosa thickness, width of keratinized tissues, marginal bone and bone thickness at the surgical site will be determined at T0-T1. Groups will be further divided into two subgroups based on mucosal thickness of the surgical site at T0 [thin mucosa (≤2.5mm) for Groups-AI/-BI; thick mucosa (>2.5mm) for Groups-AII/-BII]. A linear mixed model for repeated measures will be used for data analyses to determine changes in the dimensions of the peri-implant soft and hard tissues, around two stage-implants placed either conventionally, or in combination with the biocomplex.
详细描述
Aims & Objectives:
The present study describes a novel method to preserve the crestal bone at two-stage dental implants using autologous aBMMSCs, free of animal derived reagents, produced in clean room facilities enriched with autologous fibrin glue and seeded into commercially available collagen scaffolds (collagen fleece) that are stabilized over the implant platform upon surgical implant placement.
Primary objective:
This study aims to assess the efficacy of a novel method based on histotechnology in crestal bone preservation at two-stage dental implants, as compared to conventional surgical implant placement following the manufacturer's guidelines with no adjunctive use of grafting materials.
Secondary, changes in the peri-implant soft tissues will be also determined between implant placement and exposure and will be compared between the experimental and the conventional surgical treatment approaches.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor is not aware of the treatment modality
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systemically healthy volunteers
排除标准
- •poorly controlled systemic disease
- •heavy smoking (>20cigs/day)
- •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
- •active periodontal disease and compromised oral hygiene (PI ≥25%)
研究组 & 干预措施
Group-A
In the experimental Group (Group-A), a two-stage implant will be placed in parallel with an overlying biocomplex (aBM-MSCs/fibrin glue/collagen fleece) that comprises autologous alveolar bone marrow mesenchymal stem cells free of animal derived reagents, produced in clean room facilities and seeded into collagen scaffolds enriched with autologous fibrin glue.
干预措施: Biocomplex: aBM-MSCs/fibrin glue/collagen fleece (Biological)
Control Group-B
In Group-B, a two-stage surgical implant placement on the alveolar crest is followed based on the manufacturer's guidelines with no use of adjunctive grafting materials.
干预措施: Two-stage surgical implant placement (Procedure)
结局指标
主要结局
A reduction in the marginal bone levels
时间窗: baseline (implant placement) to 4 months (implant exposure)
Intra-surgical clinical data: Changes in the vertical distance from the implant shoulder to the alveolar crest in mm
次要结局
- Reduction in the thickness of the buccal/lingual bone(baseline (implant placement) to 4 months (implant exposure))
- Changes in the alveolar mucosa(baseline (implant placement) to 4 months (implant exposure))
- Radiographic changes in the marginal bone levels(baseline (implant placement) to 4 months (implant exposure))
- Changes in the width of keratised mucosa(baseline (implant placement) to 4 months (implant exposure))
研究者
Danae A. Apatzidou
Assist. Professor
Aristotle University Of Thessaloniki