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This study is to evaluate the safety and efficacy of Gingiva Mesenchymal Stem Cell Therapy for Chronic Adult Periodontitis.
Periodontitis featured by the progressive destruction loss of support tissues around the teeth has become a prevalent disease affecting the life quality of the adults. Although conventional periodontal treatment including open flap debridement and drug support therapy display reduced pocket depth and inflammation, the functional regeneration of the lost tissue and the repair of alveolar bone are insufficient. Gingiva mesenchymal stem cells (GMSCs) are multipotent cells possess the capacity of multilineage differentiation and have become an attractive optional treatment method for the regeneration of periodontal tissues and function. Therefore, GMSCs will be selected as seed cells to treat periodontitis. This study will recruit 30 patients which will be divided into three groups. 10 patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement. 10 patients in group B will only receive collagen scaffolds devoid of GMSCs after open flap debridement. 10 patients in group C will only undergo an open flap debridement. This study will test the safety and efficacy of GMSCs implantation in chronic adult periodontitis through alveolous bone reproduction and other clinical parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: GMSCs and collagen scaffolds | Experimental | Patients in group A will receive GMSCs seeded into collagen scaffolds at the local periodontal defects immediately after open flap debridement. |
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| Group B: collagen scaffolds | Experimental | Patients in group B will receive collagen scaffolds implantation at the local periodontal defects immediately after open flap debridement. |
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| Group C: comparator | Other | Patients in comparator group will only undergo an open flap debridement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMSCs and collagen scaffolds | Biological | Patients in this group were given GMSCs and collagen scaffolds. |
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| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of alveolar bone regeneration | A increase in the height of alveolar bone in mm examined by computed tomography (CT) | Baseline and Post cell transplantation: 1,3, 6months after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Probing pocket depth (PPD) | A reduced distance in mm between the gingival margin and the bottom was measured by a manual periodontal probe. | Baseline and Post cell transplantation: 3, 6 months after intervention. |
| Attachment level (AL) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse reaction | Adverse reaction include temperature changes, allergy, nausea and so on 6 months after intervention. | Post cell transplantation: 1, 3, 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanhai Li, Doctor | Contact | 86-311-85917287 | liquanh2@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Baoyong Yan, Doctor | Hebei Medical University | Study Chair |
| Guangshun Liu, Master | The First Hospital of Hebei Medical University | Study Director |
| Quanhai Li, Doctor |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050030 | China |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Collagen scaffolds | Biological | Patients in this group were given collagen scaffolds. |
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| Open flap debridement | Procedure | The patients in this group will only receive the treatment of open flap debridement. |
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A reduced distance in mm from the bottom of the periodontal pocket to the dentinocemental junction was examined by a manual probe.
| Baseline and Post cell transplantation: 3, 6 months after intervention. |
| Gingival index (GI) | A decreased degree of GI measured by a manual periodontal probe which was divided into 4 grades: 0, 1, 2 and 3. | Baseline and Post cell transplantation: 3, 6 months after intervention. |
| Tooth mobility degree (TMD) | A decrease of periotest value was measured by periotest to evaluate the tooth mobility changes. | Baseline and Post cell transplantation: 1,3, 6months after intervention |
| The First Hospital of Hebei Medical University |
| Study Director |
| Xianyun Wang, Doctor | The First Hospital of Hebei Medical University | Principal Investigator |
| Jinhong Zhang, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Yao Wang, Bachelor | the First Hospital of Hebei Medical UniversityT | Principal Investigator |
| Jun Zhang, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Xiangwei Ren, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Qianfeng Liu, Bachelor | The First Hospital of Hebei Medical University | Principal Investigator |
| Yongbin Di, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Boyu Liu, Bachelor | The First Hospital of Hebei Medical University | Principal Investigator |
| Fan Zhang, Bachelor | The First Hospital of Hebei Medical University | Principal Investigator |