Dental Pulp NecrosisNCT01814436
Revitalization of Immature Permanent Teeth With Necrotic Pulps Using SHED Cells
A study testing scaffold-free SHED-derived pellet in people with Dental Pulp Necrosis and Permanent Incisor Avulsed by Trauma, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells from Human Exfoliated Deciduous Teeth Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Dental Pulp Necrosis, Permanent Incisor Avulsed by Trauma
- What is being tested?
- scaffold-free SHED-derived pellet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Oct 2017
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Those who has signed the informed consent.
- Those who are between 7-years-old to 12-years-old.
- Those with at least one young permanent teeth with pulp necrosis which caused by trauma or permanent incisor avulsed by trauma.
- Those who can provide the health deciduous teeth.
- Those who have accomplished initial preparation and have been showing good compliance.
- Those whose guardians understand the purposes of the trial and are capable of making an independent decision to comply with trial requirements
- Those who are able to visit our hospital in accordance with the trial schedule
Who cannot join
- Those in an extremely poor nutritional condition (serum albumin concentration <2 g/dL)
- Those whose guardians would not cooperate with the treatment.
- Those who has uncontrollable oral disease.
- Those with severe dental fear.
- Those with coexisting mental or consciousness disorder.
- Those with teeth dysplasia and/or hereditary disease history.
Show all 16Show fewer
- Those with systemic disease which may affect the postoperative healing.
- Those with bruxism and malocclusion.
- Loss of the avulsed teeth.
- Those who are taking the medicine which would affect the postoperative healing.
- Those with the bad oral habits.
- Those who are undertaking other trail meanwhile or few weeks ago.
- Those coexisting disease of the blood or immune system.
- Those who are not capable to provide the deciduous dental pulp cells.
- Those with the severe tooth trauma (crown-root or root fracture, tooth displacement).
- Others who the investigators or sub-investigators determined as unsuitable for the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
School of Stomatology, Fourth Military Medical University
Xi'an, Shaanxi, 710032
Yan Jin, PhD, 86-29-84776147, yanjinfmmu@gmail.com
yan Jin, PhD
About this study
Official title: Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells From Human Exfoliated Deciduous Teeth
Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells from Human Exfoliated Deciduous Teeth
Read the detailed description
Irreversible damage to immature permanent teeth as a result of noxious infection or local trauma before normal physiological closure of the apical structure represents a real clinical challenge. The conventional therapeutic approach is to consider the use of synthetic biocompatible materials, such as calcium hydroxide [Ca(OH)2] and mineral trioxide aggregate (MTA), to induce apical closure, or apexification, by forming a hard tissue barrier across the root apex. However, neither MTA nor calcium hydroxide are currently able either to induce or stimulate pulp regeneration, or to ensure that conventional root development continues once damage has taken place, so that the inherent risk of root fracture remains.
Millions of teeth are accidentally avulsed each year due to the serious trauma in sports, motor vehicle accidents, criminal assaults, and fist fights, among other incidents. The risk is higher in children while their permanent teeth are still immature which may led to lots of complications and also more challenges in treatment. Generally, tooth reimplantation is the most effective therapy for tooth avulsion, As we know, The success of tooth reimplantation depends on the maintenance of vitality of the periodontal ligament, which need the parents and teachers act quickly (e.g., within 2 h) and that the avulsed tooth should preserved in an appropriate medium, such as milk or physiological saline, because the viable cells in the remaining periodontal ligament (PDL) on the root surface play a crucial role in recovering the avulsed tooth functions.
Along with the development of new regenerative protocols to resolve clinical deficiencies, continuing advances in the discovery and characterization of stem cells of dental origin-able to differentiate into multiple tissue types-have recently broadened possible therapeutic horizons towards pulp and periodontal tissue regeneration. Some studies have suggested that the recent discovery and characterization of stem cells from human exfoliated deciduous teeth (SHED) form the cell source of apexogenesis in immature teeth with periradicular periodontitis of endodontic origin. The purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and periodontal tissue in the patients with immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine.
This is a single-centre, randomized, controlled study. This study has been approved by the ethical committees of School of Stomatology, Fourth Military Medical University. The study will be conducted according to the Declaration of Helsinki.
- Being tested
- scaffold-free SHED-derived pellet
- 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.
scaffold-free SHED-derived pelletDevice
Also called SHED pellet
The purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and periodontal tissue in the patients with avulsed immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine.
| Study group | Role | What they receive |
|---|---|---|
| scaffold-free SHED-derived pellet | Experimental | Not described Receives: Device: scaffold-free SHED-derived pellet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp and Apical regeneration
The main outcome measures in the study protocol were: pulp status evaluated by dental pulp vitality tester; pulp revascularization examined by laser dopler flow meter, and the index of clinical examination. In addition, we examined whether and to what extent adverse events, for which causal relationships with the use of SHED cell was not ruled out, emerged.
The other main outcome measures in the study protocol were: the degree of apical closure; the rate of increase in root length and the change of root canal wall thickness. We examined and evaluate the anatomic morphology of teeth roots using dental computer tomography. We set rate of increase in root length as the most statistically important outcome (primary outcome).
Measured: 1 year following transplantation
Secondary outcomes (1)
Clinical parameters
periapical lesion and tooth mobility
Measured: 3~12 month following transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Pulp NecrosisStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin yan, Prof, Air Force Military Medical University, China
- Investigators
- songtao shi, PhD, Principal investigator, chool of Stomatology, Fourth Military Medical Univeristy; Ostrow School of Dentistry, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814436
- Sponsor's protocol ID
- FourthMMU2013
- Status last verified
- Apr 2016
- First submitted
- 16 Mar 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells From Human Exfoliated Deciduous Teeth
- ClinicalTrials.gov ID
- NCT01814436
- Acronym / sponsor ID
- FourthMMU2013
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 20 Mar 2013 (estimated)
- 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.
Revitalization of Young Immature Permanent Teeth With Necrotic Pulps Using Autologous Stem Cells from Human Exfoliated Deciduous Teeth
Detailed description
Irreversible damage to immature permanent teeth as a result of noxious infection or local trauma before normal physiological closure of the apical structure represents a real clinical challenge. The conventional therapeutic approach is to consider the use of synthetic biocompatible materials, such as calcium hydroxide [Ca(OH)2] and mineral trioxide aggregate (MTA), to induce apical closure, or apexification, by forming a hard tissue barrier across the root apex. However, neither MTA nor calcium hydroxide are currently able either to induce or stimulate pulp regeneration, or to ensure that conventional root development continues once damage has taken place, so that the inherent risk of root fracture remains.
Millions of teeth are accidentally avulsed each year due to the serious trauma in sports, motor vehicle accidents, criminal assaults, and fist fights, among other incidents. The risk is higher in children while their permanent teeth are still immature which may led to lots of complications and also more challenges in treatment. Generally, tooth reimplantation is the most effective therapy for tooth avulsion, As we know, The success of tooth reimplantation depends on the maintenance of vitality of the periodontal ligament, which need the parents and teachers act quickly (e.g., within 2 h) and that the avulsed tooth should preserved in an appropriate medium, such as milk or physiological saline, because the viable cells in the remaining periodontal ligament (PDL) on the root surface play a crucial role in recovering the avulsed tooth functions.
Along with the development of new regenerative protocols to resolve clinical deficiencies, continuing advances in the discovery and characterization of stem cells of dental origin-able to differentiate into multiple tissue types-have recently broadened possible therapeutic horizons towards pulp and periodontal tissue regeneration. Some studies have suggested that the recent discovery and characterization of stem cells from human exfoliated deciduous teeth (SHED) form the cell source of apexogenesis in immature teeth with periradicular periodontitis of endodontic origin. The purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and periodontal tissue in the patients with immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine.
This is a single-centre, randomized, controlled study. This study has been approved by the ethical committees of School of Stomatology, Fourth Military Medical University. The study will be conducted according to the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| scaffold-free SHED-derived pellet | Experimental | Device: scaffold-free SHED-derived pellet |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Those who has signed the informed consent.
- Those who are between 7-years-old to 12-years-old.
- Those with at least one young permanent teeth with pulp necrosis which caused by trauma or permanent incisor avulsed by trauma.
- Those who can provide the health deciduous teeth.
- Those who have accomplished initial preparation and have been showing good compliance.
Key exclusion criteria (16 listed)
- Those in an extremely poor nutritional condition (serum albumin concentration <2 g/dL)
- Those whose guardians would not cooperate with the treatment.
- Those who has uncontrollable oral disease.
- Those with severe dental fear.
- Those with coexisting mental or consciousness disorder.
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 |
|---|---|---|
| scaffold-free SHED-derived pelletAlso: SHED pelletThe purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and periodontal tissue in the patients with avulsed immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine. | Device | scaffold-free SHED-derived pellet |
Primary outcome
Pulp and Apical regeneration
Time frame: 1 year following transplantation
The main outcome measures in the study protocol were: pulp status evaluated by dental pulp vitality tester; pulp revascularization examined by laser dopler flow meter, and the index of clinical examination. In addition, we examined whether and to what extent adverse events, for which causal relationships with the use of SHED cell was not ruled out, emerged. The other main outcome measures in the study protocol were: the degree of apical closure; the rate of increase in root length and the change of root canal wall thickness. We examined and evaluate the anatomic morphology of teeth roots using dental computer tomography. We set rate of increase in root length as the most statistically important outcome (primary outcome).
1 secondary outcome
Clinical parameters
Time frame: 3~12 month following transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2016.
Related trials for Dental Pulp Necrosis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
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.
songtao shi, PhD principal investigator
chool of Stomatology, Fourth Military Medical Univeristy; Ostrow School of Dentistry, University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing scaffold-free SHED-derived pellet in people with Dental Pulp Necrosis and Permanent Incisor Avulsed by Trauma, run by Air Force Military Medical University, China at 1 site in China.
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 7 inclusion and 16 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 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact kun xuan (86-29-84776087, xuankun@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp and Apical regeneration (time frame: 1 year following transplantation). 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 Apr 2016.