The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-arm Clinical Trial Evaluating the Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization in Patients With Pulp Necrosis of Permanent Teeth

Conditions
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Pulp Necroses

Intervention / Treatment
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* Drug: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 45 years Patients with pulp necrosis of a single canal permanent tooth due to trauma or caries Patients who have signed informed consent Exclusion Criteria: Patients with pulp necrosis caused by severe trauma to the tooth, such as crown root fracture, tooth root fracture, tooth displacement, etc Patients with calcification of the apical foramen at the root of the tooth History of hereditary disorders of abnormal tooth development Dental occlusal trauma, bruxism, malocclusion Bad oral habits (sticking out the tongue, biting lips, biting nails, sucking fingers, etc.) Presence of uncontrollable pathological processes in the oral cavity (presence of acute advanced diseases in the oral cavity) Malnutrition (serum albumin concentration<2 g/dl) Patients with history of other systemic, communicable or hereditary diseases have been diagnosed Pregnant, nursing, planning to become pregnant The investigators determined that the patient was not suitable for the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm<br> | Drug: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers<br>* stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulp necrosis, pulp regeneration