Feasibility of the Preparation of an Advanced Therapy Medicinal Product for Dental Pulp Regeneration

Study Overview
=================
Brief 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. 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.

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

Conditions
-----------------
Dental Stem Cells, Dental Pulp Regeneration

Intervention / Treatment
-----------------
* Other: teeth avulsion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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, 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)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients requiring dental avulsion<br>Patients requiring dental avulsion | Other: teeth avulsion<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion |  | 1 day |