The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

NCT05728346 | Not Yet Recruiting

• 1 other identifier: Xueli Mao
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulp Necroses

Keywords

pulp necrosis; pulp regeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Blood flow in the root of tooth

  1、3、6、12、18、24 months

Study Arms (1)

single-arm

EXPERIMENTAL

Drug: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers

Interventions

Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers DRUG

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

single-arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fifth Affiliated Hospital of Guangzhou Medical University: lead

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 15, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 28, 2023

Record last verified: 2023-08