The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

Not Applicable

Not yet recruiting

• Conditions: Pulp Necroses
• Interventions: Drug: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers

• Registration Number: NCT05728346
• Lead Sponsor: Fifth Affiliated Hospital of Guangzhou Medical University

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-24
• Last Update Posted: 2023-08-28
• Study Start: 2023-09-01
• Primary Completion: 2026-06-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single-arm	Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers	-

Primary Outcome Measures

Name	Time	Method
Assessment of pulp vitality	1、3、6、12、18、24 months	Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in affected tooth.

Secondary Outcome Measures

Name	Time	Method
Blood flow in the root of tooth	1、3、6、12、18、24 months	Detection rate of blood flow in the root canal of the affected tooth by laser doppler flowmetry.