Tooth, ImpactedCELSORDINONCT03194451
Dental Stem Cells and Bone Tissue Engineering (CELSORDINO)
An observational study of Tooth, Impacted, run by Central Hospital, Nancy, France.
Trial summary
The main limitation in bone regeneration is the lack of vascularization of the newly shaped tissue. The main objective of this project is to check if the simultaneous differentiation of dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a new pre-vascularized tissue engineered… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted
- What is being tested?
- non-interventional study
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2017to 10 Jul 2019
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Patients aged between 13 and 17 years, who will be operated for wisdom tooth avulsion
Who may be able to join
- patients aged between 13 and 17 years, who will come to Dental Service of University Regional Hospital Center of Nancy in order to have a tooth avulsion.
- patient who has received a complete information about research organization and who is not opposed to the use of his own data.
- patient who the representatives of parental authority have received a complete information about research organization and who are not opposed to the use of children's data.
Who cannot join
- patients with local or general pathology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dental Stem Cells and Bone Tissue Engineering
The main limitation in bone regeneration is the lack of vascularization of the newly shaped tissue. The main objective of this project is to check if the simultaneous differentiation of dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a new pre-vascularized tissue engineered bone construct.
We will then evaluate the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.
Read the detailed description
This project aims to develop a new pre-vascularized tissue engineered bone construct, using human cells of a simple and non invasive tissue source: dental pulp.
We will isolate mesenchymal stem cells from dental tissue of wisdom teeth, extracted from patients aged between 13 and 17 years old.
The objectives are: (i) to assess in combination the endothelial differentiation and osteoblastic differentiation of dental pulp stem cells (immature third molar); (ii) to study the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.
The differentiation will be monitored by evaluation of biosynthesized matrix, bone mineralization (immunohistochimie, Westen Blot), histological response (Von Kossa, Alizarin Red) and presence and quantification of pseudo-vascular structures (angiogenesis assay), compared to reference value (commercial differentiation medium).
- Conditions
- Tooth, Impacted
- Being tested
- non-interventional study
- Keywords
- bone tissue engineering, dental stem cell differentiation
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-interventional studyOther
teeth collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineralization
Measured parameter is equal or superior to reference value (commercial differentiation medium)
Measured: Day 28 of cell culture
Secondary outcomes (1)
presence and quantification of pseudo-vascular structures
Measured parameter is equal or superior to reference value (commercial differentiation medium)
Measured: Day 28 of cell culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start10 Jul 2017 (estimated)
- Primary completion20 Aug 2017 (estimated)
- Study completion10 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa MOBY, DD, PhD, Principal investigator, IMoPA, UMR-CNRS 7365 CNRS-UL, Medicine Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194451
- Sponsor's protocol ID
- 2017-A00860-53/EUDRACT
- Acronym
- CELSORDINO
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2017
- Last updated
- 23 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Stem Cells and Bone Tissue Engineering
- ClinicalTrials.gov ID
- NCT03194451
- Acronym / sponsor ID
- CELSORDINO / 2017-A00860-53/EUDRACT
- Conditions
- Tooth, Impacted
- Keywords
- bone tissue engineering, dental stem cell differentiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 Jul 2017 (estimated)
- Primary completion
- 20 Aug 2017 (estimated)
- Study completion
- 10 Jul 2019 (estimated)
- First posted
- 21 Jun 2017 (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.
The main limitation in bone regeneration is the lack of vascularization of the newly shaped tissue. The main objective of this project is to check if the simultaneous differentiation of dental mesenchymal stem cells toward osteoblastic and endothelial lineage permits to obtain a new pre-vascularized tissue engineered bone construct.
We will then evaluate the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.
Detailed description
This project aims to develop a new pre-vascularized tissue engineered bone construct, using human cells of a simple and non invasive tissue source: dental pulp.
We will isolate mesenchymal stem cells from dental tissue of wisdom teeth, extracted from patients aged between 13 and 17 years old.
The objectives are: (i) to assess in combination the endothelial differentiation and osteoblastic differentiation of dental pulp stem cells (immature third molar); (ii) to study the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.
The differentiation will be monitored by evaluation of biosynthesized matrix, bone mineralization (immunohistochimie, Westen Blot), histological response (Von Kossa, Alizarin Red) and presence and quantification of pseudo-vascular structures (angiogenesis assay), compared to reference value (commercial differentiation medium).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Patients aged between 13 and 17 years, who will be operated for wisdom tooth avulsion
Key inclusion criteria (3 listed)
- patients aged between 13 and 17 years, who will come to Dental Service of University Regional Hospital Center of Nancy in order to have a tooth avulsion.
- patient who has received a complete information about research organization and who is not opposed to the use of his own data.
- patient who the representatives of parental authority have received a complete information about research organization and who are not opposed to the use of children's data.
Key exclusion criteria (1 listed)
- patients with local or general pathology
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 |
|---|---|---|
| non-interventional studyteeth collection | Other | – |
Primary outcome
Bone mineralization
Time frame: Day 28 of cell culture
Measured parameter is equal or superior to reference value (commercial differentiation medium)
1 secondary outcome
presence and quantification of pseudo-vascular structures
Time frame: Day 28 of cell culture
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Vanessa MOBY, DD, PhD principal investigator
IMoPA, UMR-CNRS 7365 CNRS-UL, Medicine Faculty
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth, Impacted, run by Central Hospital, Nancy, France.
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 1 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 23 Jun 2017. 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?
Contact Vanessa MOBY, DD, PhD (0383154256 ext. 33, vanessa.moby@univ-lorraine.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineralization (time frame: Day 28 of cell culture). 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 23 Jun 2017; AzTrials last refreshed its copy on 29 Oct 2026.