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

Endodontic Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437708
• Other study ID #: S56810 (ML10723) B322201421941
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: October 2020

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2020
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontic Inflammation
• Inflammation
• Pulpitis

Intervention

Procedure:
• REP with L-PRF

• REP

Biological:
• stem and progenitor cells

Locations

Country	Name	City	State
Belgium	Megabite Dental Office	Brussels
Belgium	C-Endo	Herent
Belgium	Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven	Leuven
Belgium	EndoVanGorp	Rotselaar

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	On conebeam CT (tridimensional measuring): the amount of periapical bone healing, increase in root canal wall thickness and root canal length. (composite)		3 years
Other	Patient related outcome, measured by a questionnaire		3 years
Other	Patient related outcome, measured by a pain-scale		3 years
Other	Microbial diversity in the infected immature root canal	Q-PCR analysis	intraoperative
Primary	Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.		3 years
Secondary	Amount of root development or maturogenesis,by measuring:	on intra-oral bidimensional radiographs: the increase in root canal wall thickness.	3 years
Secondary	Amount of root development or maturogenesis,by measuring:	on intra-oral bidimensional radiographs: the increase in root canal length.	3 years