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Regenerative Endodontic Procedure of Immature Permanent Teeth With L-PRF: a Pilot Controlled, Clinical Trial

NCT ID: NCT02437708

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-10-31

Brief Summary

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This study evaluates the impact of autologous 'leucocyte and platelet rich fibrin' (L-PRF) on the periapical bone healing and further root development of infected immature permanent teeth. In the test group regenerative endodontic procedure (REP) is performed with L-PRF as scaffold, in the control group REP without L-PRF is performed .

Detailed Description

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Regenerative endodontic procedures are biologically based procedures designed to restore function of a damaged and nonfunctioning pulp by stimulation of existing stem and progenitor cells present in the root canal and/or the introduction and stimulation of new stem and dental pulp progenitor cells into the root canal under conditions that are favorable to their differentiation and reestablishment of function. L-PRF has the potential advantage of creating a bioactive construct that stimulates the local environment for differentiation and proliferation of these stem and progenitor cells. We have designed this confirmatory study to test the hypothesis that the use of L-PRF in REP of infected permanent immature teeth will accelerate periapical bone healing and stimulate the root maturation.

Conditions

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Endodontic Inflammation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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REP with L-PRF

The first REP session will be performed as described by Diogenes et al. (2013). For the second REP-session a venipunction will be performed before the endodontic treatment. 2 to 4 tubes of blood will be collected per tooth. These blood samples will be put into a centrifuge for 12 minutes at 2700 rpm. Fibrin clots will be collected after centrifugation and inserted in the root canal with endodontic pluggers. Medcem Portlandcement (GmbH, Swiss) will be used instead of mineral trioxide aggregate in the second session, to prevent tooth discoloration.

Group Type EXPERIMENTAL

REP with L-PRF

Intervention Type PROCEDURE

stem and progenitor cells

Intervention Type BIOLOGICAL

REP

A REP will be performed on immature infected permanent teeth, as described in the protocol of Diogenes et al. (2013). Medcem Portlandcement (GmbH, Swiss) will be used instead of mineral trioxide aggregate in the second session, to prevent tooth discoloration.

Group Type ACTIVE_COMPARATOR

REP

Intervention Type PROCEDURE

Interventions

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REP with L-PRF

Intervention Type PROCEDURE

REP

Intervention Type PROCEDURE

stem and progenitor cells

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Provision of Informed Consent
* Permanent immature teeth with weak root canal walls (hopeless prognosis)
* Patients younger than 25 years

Exclusion Criteria

* \- Unlikely to be able to comply with the study procedures, as judged by the investigator.
* Patients older than 25 years
* Deciduous teeth
* Permanent (immature) teeth that can be treated by a "regular" root canal treatment/ apexification
* Known or suspected current malignancy
* History of chemotherapy within 5 years prior to study
* History of radiation in the head and neck region
* History of other metabolic bone diseases
* A medical history that makes REP unfavorable
* Involvement in the planning and conduct of the study
* Previous enrolment in the present study
Minimum Eligible Age

6 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Lambrechts, Prof, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium

Locations

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Megabite Dental Office

Brussels, , Belgium

Site Status

C-Endo

Herent, , Belgium

Site Status

Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven

Leuven, , Belgium

Site Status

EndoVanGorp

Rotselaar, , Belgium

Site Status

Countries

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Belgium

References

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Diogenes A, Michael AH, Teixeira FB, Hargreaves KM. An update on clinical regenerative endodontics. Endod Top. 2013;28:2-23.

Reference Type BACKGROUND

Other Identifiers

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S56810 (ML10723) B322201421941

Identifier Type: -

Identifier Source: org_study_id