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Completed

NCT Number: NCT02437708

Regenerative Endodontic Procedure of Immature Permanent Teeth With 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 .

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Key information

Conditions

Endodontic Inflammation Dental Pulp Diseases Pulpitis Stomatognathic Diseases Tooth Diseases

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Megabite Dental Office, Brussels, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

REP with L-PRF

Procedure

REP

Procedure

stem and progenitor cells

Biological

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. Amount of root development or maturogenesis,by measuring:

    Time frame: 3 years

    on intra-oral bidimensional radiographs: the increase in root canal wall thickness.

  2. Amount of root development or maturogenesis,by measuring:

    Time frame: 3 years

    on intra-oral bidimensional radiographs: the increase in root canal length.

Other outcomes

  1. 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

  2. Patient related outcome, measured by a questionnaire

    Time frame: 3 years

  3. Patient related outcome, measured by a pain-scale

    Time frame: 3 years

  4. Microbial diversity in the infected immature root canal

    Time frame: intraoperative

    Q-PCR analysis

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
May 8, 2015
Registry last updated
Nov 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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