NCT02437708

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

4.9 years

First QC Date

May 4, 2015

Last Update Submit

November 3, 2020

Conditions

Endodontic Inflammation

Keywords

regenerative endodonticsplatelet rich fibrin

Outcome Measures

Primary Outcomes (1)

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

    3 years

Secondary Outcomes (2)

  • Amount of root development or maturogenesis,by measuring:

    3 years

  • Amount of root development or maturogenesis,by measuring:

    3 years

Other Outcomes (4)

  • On conebeam CT (tridimensional measuring): the amount of periapical bone healing, increase in root canal wall thickness and root canal length. (composite)

    3 years

  • Patient related outcome, measured by a questionnaire

    3 years

  • Patient related outcome, measured by a pain-scale

    3 years

  • +1 more other outcomes

Study Arms (2)

REP with L-PRF

EXPERIMENTAL

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-PRFBiological: stem and progenitor cells

REP

ACTIVE COMPARATOR

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

Interventions

REP with L-PRFPROCEDURE
REP with L-PRF
REPPROCEDURE
REP
stem and progenitor cellsBIOLOGICAL
REP with L-PRF

Eligibility Criteria

Age6 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Megabite Dental Office

Brussels, 1082, Belgium

Location

C-Endo

Herent, 3020, Belgium

Location

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

Leuven, 3000, Belgium

Location

EndoVanGorp

Rotselaar, 3110, Belgium

Location

Related Publications (1)

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

    BACKGROUND

MeSH Terms

Conditions

Pulpitis

Interventions

Microscopy, Electron, Scanning Transmission

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Microscopy, Electron, TransmissionMicroscopy, ElectronMicroscopyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Paul Lambrechts, Prof, Dr

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2015

First Posted

May 8, 2015

Study Start

September 1, 2014

Primary Completion

August 1, 2019

Study Completion

October 1, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Locations

BE(4)