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

July 20, 2016 updated by: Centre Hospitalier Universitaire de Besancon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

July 18, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (ESTIMATE)

July 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • API/2014/47

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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