An interventional study of Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers in Pulp Necroses, sponsored by Fifth Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-28.
Sponsored by Fifth Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
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.
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.
157 studies on the registry are indexed under Dental Pulp Necrosis; 44 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 148 interventional studies indexed under Dental Pulp Necrosis.
Browse Dental Pulp Necrosis studies →Fifth Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 1、3、6、12、18、24 months
Blood flow in the root of tooth
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
No study locations are listed for this record.
Start is estimated for Sep 2023; primary completion for Jun 2026, 33 months later.
Of 66 non-industry interventional studies with no phase under Dental Pulp Necrosis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 33 months is above that.
Counting every sponsor, half of 67 studies reached it within 15 months; a quarter within 9 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Fifth Affiliated Hospital of Guangzhou Medical University