Study of Local Periodontal Regeneration of Chronic Periodontal Disease Patients Receiving Allogeneic Human Dental Pulp Stem Cells Injection Therapy
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year
研究概览
简要总结
The purpose of this study is to evaluate the safety of clinical injection of allogeneic human dental pulp stem cell(DPSC) in local infected periodontal tissue and determine whether injection of allogeneic DPSC is a effective way in the treatment of chronic periodontal disease.
详细描述
This study will involve 40 patients who were diagnosed as chronic periodontitis will receive periodontal scaling and root planing. Patients will randomly be divided at the base line into two groups.In test group, 20 chronic periodontitis patients will be treated using local DPSC injection. Whereas, a control group will contain 20 patients who will be treated using placebo. Clinical examination including Quigley-Hein plaque index (QHI), bleeding on probing (BoP), probing depth (PD), clinical attachment level (CAL), and gingival recession (GR) will be perform in different time points during the study. Radiographic and clinical examination will be carried out during the late healing phase up to 12 months post operation.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of periodontal disease will be based on clinical assessment of:
- •Quigley-Hein index (QHI)
- •Bleeding on Probing (BoP)
- •Pocket Probing Depth (PD)
- •gingival recession (GR)
- •Clinical Attachment Level (CAL)
- •furcation involvement,and
- •radiographical assessment. All patients at the base line of this study should have been received the initial treatment and reached the qualified level of oral hygiene to be included in the next stage.
排除标准
- •Pregnant,
- •immunosuppressed or diabetes patients,
- •patients exhibit gingival hypertrophy,
- •require premedication, and
- •who have been taking systemic anti-inflammatory medications, or
- •have taken antibiotics or
- •received periodontal instrumentation within 6 months prior to the study, will be excluded.
结局指标
主要结局
Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year
时间窗: Baseline and 1 year after intervention.
次要结局
- Change from Baseline Probing depth (PD) at 1 year(Baseline and 1 year after intervention.)
- Change from Baseline Clinical attachment level (CAL) at 1 year(Baseline and 1 year after intervention)
- Quigley-Hein plaque index (QHI)(Baseline)
- Change from Baseline Bleeding on probing (BoP) at 1 year(Baseline and 1 year after intervention.)
研究者
Songlin Wang
Professor and Vice President of Capital Medical University
Capital Medical University