The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

N/ANot Yet RecruitingNCT05728346

Fifth Affiliated Hospital of Guangzhou Medical University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulp Necroses

Interventions

Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymersDRUG

stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1、3、6、12、18、24 months

Secondary Outcomes

Blood flow in the root of tooth

Detection rate of blood flow in the root canal of the affected tooth by laser doppler flowmetry.

Time frame: 1、3、6、12、18、24 months

Data from ClinicalTrials.gov

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