search
Back to results

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

Primary Purpose

Endodontic Inflammation

Status
Completed
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
REP with L-PRF
REP
stem and progenitor cells
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Inflammation focused on measuring regenerative endodontics, platelet rich fibrin

Eligibility Criteria

6 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Megabite Dental Office
  • C-Endo
  • Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven
  • EndoVanGorp

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REP with L-PRF

REP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.

Secondary Outcome Measures

Amount of root development or maturogenesis,by measuring:
on intra-oral bidimensional radiographs: the increase in root canal wall thickness.
Amount of root development or maturogenesis,by measuring:
on intra-oral bidimensional radiographs: the increase in root canal length.

Full Information

First Posted
May 4, 2015
Last Updated
November 3, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
search

1. Study Identification

Unique Protocol Identification Number
NCT02437708
Brief Title
Regenerative Endodontic Procedure of Immature Permanent Teeth With L-PRF: a Pilot Controlled, Clinical Trial
Official Title
Regenerative Endodontic Procedure of Immature Permanent Teeth With the Use of Autologous L-PRF: a Pilot Controlled, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Inflammation
Keywords
regenerative endodontics, platelet rich fibrin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REP with L-PRF
Arm Type
Experimental
Arm Description
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.
Arm Title
REP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
REP with L-PRF
Intervention Type
Procedure
Intervention Name(s)
REP
Intervention Type
Biological
Intervention Name(s)
stem and progenitor cells
Primary Outcome Measure Information:
Title
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Amount of root development or maturogenesis,by measuring:
Description
on intra-oral bidimensional radiographs: the increase in root canal wall thickness.
Time Frame
3 years
Title
Amount of root development or maturogenesis,by measuring:
Description
on intra-oral bidimensional radiographs: the increase in root canal length.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
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
Title
Patient related outcome, measured by a questionnaire
Time Frame
3 years
Title
Patient related outcome, measured by a pain-scale
Time Frame
3 years
Title
Microbial diversity in the infected immature root canal
Description
Q-PCR analysis
Time Frame
intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Lambrechts, Prof, Dr
Organizational Affiliation
Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Megabite Dental Office
City
Brussels
ZIP/Postal Code
1082
Country
Belgium
Facility Name
C-Endo
City
Herent
ZIP/Postal Code
3020
Country
Belgium
Facility Name
Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
EndoVanGorp
City
Rotselaar
ZIP/Postal Code
3110
Country
Belgium

12. IPD Sharing Statement

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs