Endodontic InflammationPhase 3NCT02437708
Regenerative Endodontic Procedure of Immature Permanent Teeth With L-PRF: a Pilot Controlled, Clinical Trial
A Phase 3 study testing REP with L-PRF, REP and stem and progenitor cells in people with Endodontic Inflammation, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Endodontic Inflammation
- What is being tested?
- REP with L-PRF, REP and stem and progenitor cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesBelgium
- Study dates
- Sep 2014to Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of Informed Consent
- Permanent immature teeth with weak root canal walls (hopeless prognosis)
- Patients younger than 25 years
Who cannot join
- - 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Megabite Dental Office
Brussels, 1082
C-Endo
Herent, 3020
Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven
Leuven, 3000
EndoVanGorp
Rotselaar, 3110
About this study
Official title: Regenerative Endodontic Procedure of Immature Permanent Teeth With the Use of Autologous 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 .
Read the 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.
- Conditions
- Endodontic Inflammation
- Being tested
- REP with L-PRF, REP, stem and progenitor cells
- Keywords
- regenerative endodontics, platelet rich fibrin
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REP with L-PRFProcedure or surgery
REPProcedure or surgery
stem and progenitor cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| REP with L-PRF | Experimental | 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. Receives: Procedure: REP with L-PRF; Biological: stem and progenitor cells |
| REP | Active comparator | 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. Receives: Procedure: REP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
Measured: 3 years
Secondary outcomes (2)
Amount of root development or maturogenesis,by measuring:
on intra-oral bidimensional radiographs: the increase in root canal wall thickness.
Measured: 3 years
Amount of root development or maturogenesis,by measuring:
on intra-oral bidimensional radiographs: the increase in root canal length.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2014
- Primary completionAug 2019
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endodontic InflammationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Lambrechts, Prof, Dr, Principal investigator, Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437708
- Sponsor's protocol ID
- S56810 (ML10723) B322201421941
- Status last verified
- Nov 2020
- First submitted
- 4 May 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Diogenes A, Michael AH, Teixeira FB, Hargreaves KM. An update on clinical regenerative endodontics. Endod Top. 2013;28:2-23.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Endodontic Procedure of Immature Permanent Teeth With the Use of Autologous L-PRF: a Pilot Controlled, Clinical Trial
- ClinicalTrials.gov ID
- NCT02437708
- Acronym / sponsor ID
- S56810 (ML10723) B322201421941
- Conditions
- Endodontic Inflammation
- Keywords
- regenerative endodontics, platelet rich fibrin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Aug 2019 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REP with L-PRF | Experimental | Procedure: REP with L-PRF, Biological: stem and progenitor cellsThe 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 | Active comparator | Procedure: REPA 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. |
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Provision of Informed Consent
- Permanent immature teeth with weak root canal walls (hopeless prognosis)
- Patients younger than 25 years
Key exclusion criteria (11 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REP with L-PRF | Procedure or surgery | REP with L-PRF |
| REP | Procedure or surgery | REP |
| stem and progenitor cells | Biological | REP with L-PRF |
Primary outcome
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs.
Time frame: 3 years
2 secondary outcomes
Amount of root development or maturogenesis,by measuring:
Time frame: 3 years
Amount of root development or maturogenesis,by measuring:
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- BackgroundDiogenes A, Michael AH, Teixeira FB, Hargreaves KM. An update on clinical regenerative endodontics. Endod Top. 2013;28:2-23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Lambrechts, Prof, Dr principal investigator
Department of Oral Health Sciences, KU Leuven & Dentistry, University Hospitals Leuven, Belgium
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing REP with L-PRF, REP and stem and progenitor cells in people with Endodontic Inflammation, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of periapical bone healing, measured on intra-oral bidimensional radiographs. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02437708, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.