NCT05728346

The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fifth Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulp Necroses

Interventions

Type	Name	Description
DRUG	Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers	stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers

Timeline

• Start date: 2023-09-01
• Primary completion: 2026-06-30
• Completion: 2026-09-30
• First posted: 2023-02-15
• Last updated: 2023-08-28