Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers
Drugstem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers
NCT Number: NCT05728346
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.
Trial opening soon.
Get Notified18 year–45 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers
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.
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.
Fifth Affiliated Hospital of Guangzhou Medical University
Other
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
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