The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers.
- Who it may be relevant to
- Registry conditions: Pulp Necroses. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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
Primary outcome measures
- Assessment of pulp vitality [Time frame: 1、3、6、12、18、24 months]
Secondary outcome measures (1)
- Blood flow in the root of tooth [Time frame: 1、3、6、12、18、24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05728346 · Xueli Mao