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

Phase 3

Completed

• Conditions: Endodontic Inflammation
• Interventions: Procedure: REP with L-PRF; Procedure: REP; Biological: stem and progenitor cells

• Registration Number: NCT02437708
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-05-04
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Primary Completion: 2019-08
• Study Completion: 2020-10
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REP with L-PRF	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.
REP	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.
REP with L-PRF	stem and progenitor cells	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.

Primary Outcome Measures

Name	Time	Method
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.	3 years

Secondary Outcome Measures

Name	Time	Method
Amount of root development or maturogenesis,by measuring:	3 years	on intra-oral bidimensional radiographs: the increase in root canal length.

Trial Locations

Locations (4)

Megabite Dental Office; 🇧🇪 Brussels, Belgium

C-Endo; 🇧🇪 Herent, Belgium

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

EndoVanGorp; 🇧🇪 Rotselaar, Belgium