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Dental pulp necrosis is one of the most common pathological conditions that results in tooth loss. However, regeneration of functional dental pulp has proved difficult. Therefore, the investigators conduct a single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth.
This study is a single-center, prospective, single-arm study to evaluate the efficacy and safety of pulp regeneration induced by SHED mixed with hyaluronic acid polymerization in patients with pulp necrosis of permanent teeth. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. All participants in this study will receive stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers after the preparation and disinfection of the root canal of the affected teeth. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers | Drug | stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pulp vitality | Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in affected tooth. | 1、3、6、12、18、24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood flow in the root of tooth | Detection rate of blood flow in the root canal of the affected tooth by laser doppler flowmetry. | 1、3、6、12、18、24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |