Human Intrabony Defect Regeneration With Micro-grafts Containing Dental Pulp Stem Cells: a Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 4
- 主要终点
- Radiographic bone fill
研究概览
简要总结
The goal of this study is to evaluate if dental pulp stem cells (DPSCs) delivered into intrabony defects in a collagen scaffold would enhance the clinical and radiographic parameters of periodontal regeneration.
详细描述
In this randomized controlled trial, 29 chronic periodontitis patients presenting one deep intrabony defect and requiring extraction of one vital tooth were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of minimally invasive surgical technique. The dental pulp of the extracted tooth was mechanically dissociated to obtain micro-grafts rich in autologous DPSCs. Test sites (n=15) were filled with micro-grafts seeded onto collagen sponge, whereas control sites (n=14) with collagen sponge alone. Clinical and radiographic parameters were recorded at baseline, 6 and 12 months postoperatively.
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
- Triple (Participant, Investigator, 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
- •diagnosis of advanced chronic periodontitis
- •FMPS<20%
- •FMBS<20%
- •infrabony defect >2mm
- •Probing depth >5mm
- •presence of 1 vital and intact tooth requiring an extraction as autologous source of DPSCs
排除标准
- •controindicazion for periodontal surgery
- •systemic diseases affecting periodontal healing
- •pregnancy an lactation
- •fixed orthodontic appliance
- •history of periodontal surgery at the experimental teeth
- •prostethic restorations at the experimental teeth
- •furcation defects
研究组 & 干预措施
Dental pulp stem cells
Test sites (n=15) Periodontal regeneration using micro-grafts of Dental pulp stem cells seeded onto collagen sponge
干预措施: periodontal regeneration (Procedure)
coagulum
control sites (n=14) Periodontal regeneration using coagulum and collagen sponge alone
干预措施: periodontal regeneration (Procedure)
结局指标
主要结局
Radiographic bone fill
时间窗: baseline and 12 months
Periapical standardized radiographs were taken by a clinician masked to the clinical measurements using the paralleling technique and individually customized bite-blocks (RINN XCP Film Holding Instruments, Dentsply, York, USA)
次要结局
- Recession reduction(baseline, 6 and 12 months)
- Probing depth reduction(baseline, 6 and 12 months)
- Clinical attachment gain(baseline, 6 and 12 months)
研究者
Francesco Ferrarotti
Adjunct Professor
University of Turin, Italy