Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DPSC injection | Experimental | 20 patients will receive DPSC injection(1000000 cells/ 0.5ml) at the local periodontal defects immediately after periodontal scaling and root planing. |
|
| Placebo control | Placebo Comparator | 20 patients will receive saline injection at the local periodontal defects immediately after periodontal scaling and root planing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPSC injection | Genetic | A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline alveolar bone volume examined by computed tomography(CT) at 1 year | Baseline and 1 year after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Quigley-Hein plaque index (QHI) | Baseline | |
| Change from Baseline Bleeding on probing (BoP) at 1 year | Baseline and 1 year after intervention. | |
| Change from Baseline Probing depth (PD) at 1 year |
Not provided
Inclusion Criteria:
Diagnosis of periodontal disease will be based on clinical assessment of:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Songlin Wang, Ph.D | Contact | +86 13601324511 | slwang@ccmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Songlin Wang, Ph.D | Beijing Key Laboratory of Tooth Regeneration and Function Reconstruction, Capital Medical University School of Stomatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Capital Medical University School of Stomatology | Recruiting | Beijing | Beijing Municipality | 100050 | China |
Not provided
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing. |
|
| Baseline and 1 year after intervention. |
| Change from Baseline Clinical attachment level (CAL) at 1 year | Baseline and 1 year after intervention |