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Feasibility of the Preparation of an Advanced Therapy Medicinal Product for Dental Pulp Regeneration (Pulp'R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02842515
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment
Dental Stem Cells Dental Pulp Regeneration Other: teeth avulsion

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Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
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
Study Start Date : January 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Group/Cohort Intervention/treatment
Patients requiring dental avulsion
Patients requiring dental avulsion
Other: teeth avulsion

Primary Outcome Measures :
  1. Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
Dental Pulp stem cells

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

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)
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Responsible Party: Centre Hospitalier Universitaire de Besancon Identifier: NCT02842515    
Other Study ID Numbers: API/2014/47
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016