NCT03194451

Brief 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 bone construct. We will then evaluate the boosting effect of the conditionned medium on cell differentiation and production of a prevascularized bone construct.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 21, 2017

Completed
19 days until next milestone

Study Start

First participant enrolled

July 10, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

1 month

First QC Date

June 16, 2017

Last Update Submit

June 22, 2017

Conditions

Tooth, Impacted

Keywords

bone tissue engineering, dental stem cell differentiation

Outcome Measures

Primary Outcomes (1)

  • Bone mineralization

    Measured parameter is equal or superior to reference value (commercial differentiation medium)

    Day 28 of cell culture

Secondary Outcomes (1)

  • presence and quantification of pseudo-vascular structures

    Day 28 of cell culture

Interventions

non-interventional studyOTHER

teeth collection

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients aged between 13 and 17 years, who will be operated for wisdom tooth avulsion

You may qualify if:

  • 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.

You may not qualify if:

  • patients with local or general pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

teeth

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Vanessa MOBY, DD, PhD

    IMoPA, UMR-CNRS 7365 CNRS-UL, Medicine Faculty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanessa MOBY, DD, PhD

CONTACT

0383154256vanessa.moby@univ-lorraine.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 21, 2017

Study Start

July 10, 2017

Primary Completion

August 20, 2017

Study Completion

July 10, 2019

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share