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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.
 
ClinicalTrials.gov Identifier: NCT02842515
Recruitment Status : Completed
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date July 18, 2016
First Posted Date July 25, 2016
Last Update Posted Date July 25, 2016
Study Start Date January 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 20, 2016)
Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Feasibility of the Preparation of an Advanced Therapy Medicinal Product for Dental Pulp Regeneration
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Dental Pulp stem cells
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.
Condition
  • Dental Stem Cells
  • Dental Pulp Regeneration
Intervention Other: teeth avulsion
Study Groups/Cohorts Patients requiring dental avulsion
Patients requiring dental avulsion
Intervention: Other: teeth avulsion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 20, 2016)
30
Original Actual Enrollment Same as current
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02842515
Other Study ID Numbers API/2014/47
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date July 2016