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

November 3, 2020 updated by: Universitaire Ziekenhuizen KU Leuven

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1082
        • Megabite Dental Office
      • Herent, Belgium, 3020
        • C-Endo
      • Leuven, Belgium, 3000
        • Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven
      • Rotselaar, Belgium, 3110
        • EndoVanGorp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: REP with L-PRF
Biological: stem and progenitor cells
Active Comparator: 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.
Procedure: REP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of root development or maturogenesis,by measuring:
Time Frame: 3 years
on intra-oral bidimensional radiographs: the increase in root canal wall thickness.
3 years
Amount of root development or maturogenesis,by measuring:
Time Frame: 3 years
on intra-oral bidimensional radiographs: the increase in root canal length.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
On conebeam CT (tridimensional measuring): the amount of periapical bone healing, increase in root canal wall thickness and root canal length. (composite)
Time Frame: 3 years
3 years
Patient related outcome, measured by a questionnaire
Time Frame: 3 years
3 years
Patient related outcome, measured by a pain-scale
Time Frame: 3 years
3 years
Microbial diversity in the infected immature root canal
Time Frame: intraoperative
Q-PCR analysis
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Paul Lambrechts, Prof, Dr, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S56810 (ML10723) B322201421941

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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