Regenerative Endodontic Procedure of Immature Permanent Teeth With the Use of Autologous L-PRF: a Pilot Controlled, Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Endodontic Inflammation
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
Time Frame: 3 years
Secondary Outcomes
- Amount of root development or maturogenesis,by measuring:(3 years)