Dental Stem CellsPulp'RNCT02842515
Feasibility of the Preparation of an Advanced Therapy Medicinal Product for Dental Pulp Regeneration
An observational study of Dental Stem Cells and Dental Pulp Regeneration, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
Current endodontic treatment are based essentially on the ouster of parenchyma in case of trauma or irreversible pulp inflammation. These situations typically affect immature teeth in subjects aged from 8 to 15 years. Read more about this study
- Who is it for?
- Ages 8 to 20 years
- Conditions the study is for
- Dental Stem Cells, Dental Pulp Regeneration
- What is being tested?
- teeth avulsion
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jul 2015
- Phase
- Observational
- 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 8 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male or Female aged from 8 to 15 years, with at least one tooth affected by a carious process, or a major trauma preventing the maintenance of the tooth in the arch, or requiring avulsion germs wisdom teeth.
Who may be able to join
- Patients aged from 8 to 15 years, with at least one tooth affected by a carious process,
- Patients aged from 8 to 15 years with major trauma preventing the maintenance of the tooth in the arch
- Patients aged from 16 to 20 years requiring avulsion germs wisdom teeth,
- Ability to carry out the extraction of pulp chamber content
- Signature of informed consent (from the patient and his guardian)
- Indication that the subject has understood the purpose and procedures required by the study and agrees to participate in the study and comply with the requirements and limitations inherent in this study,
- Patient with French social insurance.
Who cannot join
- Lack of ability to collect the dental pulp,
- Presence of necrosis in pulp complex or the possibility of preserving the pulp through appropriate techniques,
- Legal incapacity or limited legal capacity
- Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator,
- Patient without health insurance,
- The patient is in the period of exclusion of another study,
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- Patients with congenital pathology of dental pulp (amelogenesis and dentinogenesis imperfect)
- Patient with intrapulpal calcification or violations of pulp obliteration
- Teeth having external or internal inflammatory resorption
- Teeth diagnosed with pulp necrosis process
- Teeth undergoing fragmentation for their avulsion
- Time of pulp air exposition > 2 hours (risk of bacterial contamination)
About this study
Official title: Study the Feasibility of Preparing an Autologous Advanced Therapy Medicinal Product for the Dental Pulp Regeneration in the Patient With Irreversible Pulp Inflammation or Dental Trauma
Current endodontic treatment are based essentially on the ouster of parenchyma in case of trauma or irreversible pulp inflammation. These situations typically affect immature teeth in subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to discontinuation of root development and apical closure. The challenge for the clinician in the management of such situations is then preserving a pulp vitality. But current practices consist in a filling of the endo-canal system with an inert or semi-inert material. In this case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is the study the feasibility of preparing an autologous combined advanced therapy medicinal product (ATMP) for dental pulp regeneration in the patient with irreversible pulp inflammation or dental trauma.
- Conditions
- Dental Stem Cells, Dental Pulp Regeneration
- Being tested
- teeth avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
teeth avulsionOther
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring dental avulsion | Patients requiring dental avulsion Receives: Other: teeth avulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Stem CellsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842515
- Sponsor's protocol ID
- API/2014/47
- Acronym
- Pulp'R
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study the Feasibility of Preparing an Autologous Advanced Therapy Medicinal Product for the Dental Pulp Regeneration in the Patient With Irreversible Pulp Inflammation or Dental Trauma
- ClinicalTrials.gov ID
- NCT02842515
- Acronym / sponsor ID
- Pulp'R / API/2014/47
- Conditions
- Dental Stem Cells, Dental Pulp Regeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jul 2016 (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.
Current endodontic treatment are based essentially on the ouster of parenchyma in case of trauma or irreversible pulp inflammation. These situations typically affect immature teeth in subjects aged from 8 to 15 years. Consequently, loss of a functional pulp is leads to discontinuation of root development and apical closure. The challenge for the clinician in the management of such situations is then preserving a pulp vitality. But current practices consist in a filling of the endo-canal system with an inert or semi-inert material. In this case, no pulp vitality is present. New treatment methods are needed. The objective Pulp'R is the study the feasibility of preparing an autologous combined advanced therapy medicinal product (ATMP) for dental pulp regeneration in the patient with irreversible pulp inflammation or dental trauma.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring dental avulsion | – | Other: teeth avulsionPatients requiring dental avulsion |
Who may qualify
- Ages
- 8 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male or Female aged from 8 to 15 years, with at least one tooth affected by a carious process, or a major trauma preventing the maintenance of the tooth in the arch, or requiring avulsion germs wisdom teeth.
Key inclusion criteria (7 listed)
- Patients aged from 8 to 15 years, with at least one tooth affected by a carious process,
- Patients aged from 8 to 15 years with major trauma preventing the maintenance of the tooth in the arch
- Patients aged from 16 to 20 years requiring avulsion germs wisdom teeth,
- Ability to carry out the extraction of pulp chamber content
- Signature of informed consent (from the patient and his guardian)
Key exclusion criteria (12 listed)
- Lack of ability to collect the dental pulp,
- Presence of necrosis in pulp complex or the possibility of preserving the pulp through appropriate techniques,
- Legal incapacity or limited legal capacity
- Patient unlikely to cooperate in the study and / or low cooperation anticipated by the investigator,
- Patient without health insurance,
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 |
|---|---|---|
| teeth avulsion | Other | Patients requiring dental avulsion |
Primary outcome
Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
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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?
An observational study of Dental Stem Cells and Dental Pulp Regeneration, run by Centre Hospitalier Universitaire de Besancon.
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 12 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: finished, as of the sponsor's last update on 25 Jul 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion (time frame: 1 day). 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 25 Jul 2016.