The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

August 24, 2023 updated by: Xueli Mao, Fifth Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single-arm
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of pulp vitality
Time Frame: 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.
1、3、6、12、18、24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood flow in the root of tooth
Time Frame: 1、3、6、12、18、24 months
Detection rate of blood flow in the root canal of the affected tooth by laser doppler flowmetry.
1、3、6、12、18、24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fifth Affiliated Hospital of Guangzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 28, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xueli Mao

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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