NCT02842515

Completed

Feasibility of the Preparation of an Advanced Therapy Medici...

Centre Hospitalier Universitaire de Besancon Source

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Other study identifiers

Sponsor study identifier

API/2014/47

Study Type

observational

Actual enrollment (reported)

30

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 2015

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 30 participants
Study completion date: July 2015
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2015
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2015
Actual (reported)
Study Completion
July 2015
Actual (reported)
First Submitted
July 18, 2016
Actual (reported)
First Posted
July 25, 2016
Actual (reported)

Last Updated: July 25, 2016
Status Verified: July 2016
Last Update Submitted: July 20, 2016

Conditions

Dental Pulp Regeneration Dental Stem Cells

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

Other: teeth avulsion

Interventions

teeth avulsionOther

Patients requiring dental avulsion

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age8 Years - 20 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodNon-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,

Sponsors & Collaborators

Centre Hospitalier Universitaire de Besancon
Otherlead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dental Pulp stem cells

Enrollment

30 participants (actual enrollment reported by the registry).

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 2015

Date type not reported

This date has not been verified as actual or estimated.

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)

Contact the study team to confirm eligibility.

Primary Completion

July 2015

Actual (reported)

Study Completion

July 2015

Actual (reported)

Last Updated

July 25, 2016

Record last verified: 2016-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02842515
Data provider: ClinicalTrials.gov
Source updated: 2016-07-25
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:21 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Patients requiring dental avulsion

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Biospecimen

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record