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The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

Primary Purpose

Pulp Necroses

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers
Sponsored by
Fifth Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necroses focused on measuring pulp necrosis, pulp regeneration

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    single-arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Blood flow in the root of tooth
    Detection rate of blood flow in the root canal of the affected tooth by laser doppler flowmetry.

    Full Information

    First Posted
    January 30, 2023
    Last Updated
    August 24, 2023
    Sponsor
    Fifth Affiliated Hospital of Guangzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05728346
    Brief Title
    The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2026 (Anticipated)
    Study Completion Date
    September 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fifth Affiliated Hospital of Guangzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necroses
    Keywords
    pulp necrosis, pulp regeneration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    single-arm
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers
    Intervention Description
    stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers
    Primary Outcome Measure Information:
    Title
    Assessment of pulp vitality
    Description
    Change in pulpal vitality will be assessed through pulpal response to sensitivity tests (cold, hot and electrical test) in affected tooth.
    Time Frame
    1、3、6、12、18、24 months
    Secondary Outcome Measure Information:
    Title
    Blood flow in the root of tooth
    Description
    Detection rate of blood flow in the root canal of the affected tooth by laser doppler flowmetry.
    Time Frame
    1、3、6、12、18、24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

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    The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization

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