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

NCT02842515 | Completed

• 1 other identifier: API/2014/47
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Stem Cells; Dental Pulp Regeneration

Outcome Measures

Primary Outcomes (1)

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

  1 day

Study Arms (1)

Patients requiring dental avulsion

Patients requiring dental avulsion

Other: teeth avulsion

Interventions

teeth avulsion OTHER

Patients requiring dental avulsion

Eligibility Criteria

• Age: 8 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dental Pulp stem cells

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 25, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 25, 2016

Record last verified: 2016-07