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

Dental Pulp Regeneration Clinical Trial

— Pulp'R  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842515
• Other study ID #: API/2014/47
• Status: Completed
• Phase: N/A
• First received: July 18, 2016
• Last updated: July 20, 2016
• Start date: January 2015
• Est. completion date: July 2015

Study information

• Verified date: July 2016
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 20 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dental Pulp Regeneration
• Dental Stem Cells

Intervention

Other:
• teeth avulsion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of stem cell lines established from pulp removed during either traumatic or carious teeth avulsion		1 day	No