Clinical trial NCT02437708: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Endodontic Inflammation
Keywords: regenerative endodontics
platelet rich fibrin
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2015-05-08
Enrollment: 29
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
timeFrame: 3 years
Secondary outcomes:
measure: Amount of root development or maturogenesis,by measuring:
timeFrame: 3 years
measure: Amount of root development or maturogenesis,by measuring:
timeFrame: 3 years
Other outcomes:
measure: On conebeam CT (tridimensional measuring): the amount of periapical bone healing, increase in root canal wall thickness and root canal length. (composite)
timeFrame: 3 years
measure: Patient related outcome, measured by a questionnaire
timeFrame: 3 years
measure: Patient related outcome, measured by a pain-scale
timeFrame: 3 years
measure: Microbial diversity in the infected immature root canal
timeFrame: intraoperative
Locations:
city: Brussels
country: Belgium
facility: Megabite Dental Office
city: Herent
country: Belgium
facility: C-Endo
city: Leuven
country: Belgium
facility: Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven
city: Rotselaar
country: Belgium
facility: EndoVanGorp
Study officials:
affiliation: Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium
name: Paul Lambrechts, Prof, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diogenes A, Michael AH, Teixeira FB, Hargreaves KM. An update on clinical regenerative endodontics. Endod Top. 2013;28:2-23.