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NCT Number: NCT05728346

The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fifth Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 15, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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