The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

Pulp Necroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05728346
• Other study ID #: Xueli Mao
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: August 2023
• Source: Fifth Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Pulp Necroses

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital of Guangzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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