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Completed

NCT Number: NCT02842515

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

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.

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Key information

Conditions

Dental Stem Cells Dental Pulp Regeneration

Age range

8 year–20 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

teeth avulsion

Other

Primary outcomes

  1. Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study 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

Acronym: Pulp'R

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 25, 2016
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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