Pulp NecrosesNCT05728346
The Efficacy and Safety of Pulp Regeneration Induced by SHED Polymerization
A study testing Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers in people with Pulp Necroses, run by Fifth Affiliated Hospital of Guangzhou Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necroses
- What is being tested?
- Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Pulp Necroses
- Being tested
- Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers
- Keywords
- pulp necrosis, pulp regeneration
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymersDrug
stem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers
| Study group | Role | What they receive |
|---|---|---|
| single-arm | Experimental | Not described Receives: Drug: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1、3、6、12、18、24 months
Secondary outcomes (1)
Blood flow in the root of tooth
Detection rate of blood flow in the root canal of the affected tooth by laser doppler flowmetry.
Measured: 1、3、6、12、18、24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Sep 2023 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueli Mao, Fifth Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728346
- Sponsor's protocol ID
- Xueli Mao
- Status last verified
- Aug 2023
- First submitted
- 30 Jan 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05728346
- Acronym / sponsor ID
- Xueli Mao
- Conditions
- Pulp Necroses
- Keywords
- pulp necrosis, pulp regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single-arm | Experimental | Drug: Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymersstem cells from human exfoliated deciduous teeth (SHED) mixed with hyaluronic acid polymers | Drug | single-arm |
Primary outcome
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.
1 secondary outcome
Blood flow in the root of tooth
Time frame: 1、3、6、12、18、24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic human pulp mesenchymal stem cells mixed with hyaluronic acid polymers in people with Pulp Necroses, run by Fifth Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of pulp vitality (time frame: 1、3、6、12、18、24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.