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

• ClinicalTrials.gov Identifier: NCT02842515
• Recruitment Status: Completed
• First Posted: July 25, 2016
• Last Update Posted: July 25, 2016
• Sponsor: Centre Hospitalier Universitaire de Besancon
• 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

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

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
• Current Responsible Party: Centre Hospitalier Universitaire de Besancon
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Universitaire de Besancon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Universitaire de Besancon
• Verification Date: July 2016