Necrotic PulpNCT03698188
Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates
A study testing Injectable platelet-rich fibrin and Platelet-rich plasma in people with Necrotic Pulp, run by Cairo University.
Trial summary
Injectable platelet-rich fibrin (I-PRF) is a flowable blood concentrate that is entirely natural and allows ease of access and flow within the root canal. It was first developed in 2014 by modifying the centrifugation parameters. I-PRF has great potential in the field of endodontics. Read more about this study
- Who is it for?
- Ages 10 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Injectable platelet-rich fibrin and Platelet-rich plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to May 2020
- Phase
- Interventional
- 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 10 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients having necrotic maxillary anterior tooth/teeth due to caries or trauma
- Radiographic criteria: preoperative radiograph showing incomplete root formation with a wide apical foramen.
- Positive patient/guardian compliance for participation in the study.
Who cannot join
- Uncooperative patient
- Lack of patient commitment to the treatment plan and the follow-up period
- Mature necrotic anterior teeth due to caries or trauma
- Vital maxillary anterior teeth with open apices
- Non-restorable teeth
- Grossly decayed or fractured teeth that require post and core as final restorations
- Presence of periodontal pockets
- Radiographically: presence of external or internal root resorption, fracture lines or cracks
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Efficacy of Injectable Platelet-Rich Fibrin Versus Platelet-Rich Plasma in the Regeneration of Necrotic Immature Maxillary Anterior Teeth. (A Randomized Clinical Trial)
Injectable platelet-rich fibrin (I-PRF) is a flowable blood concentrate that is entirely natural and allows ease of access and flow within the root canal. It was first developed in 2014 by modifying the centrifugation parameters. I-PRF has great potential in the field of endodontics. At present, it is still in its infancy and needs to be explored with regard to its regenerative efficacy.
To the best of our knowledge, this study is the first to clinically and comparatively investigate Platelet-rich plasma (PRP) and I-PRF.
Read the detailed description
An ideal treatment option for an immature necrotic tooth is the regeneration of pulp-like tissue that is capable of boosting the continuation of normal root development. The use of platelet concentrates for that purpose is a clinically relevant, minimally invasive approach which has a promising potential of reducing the healing period. Among which, the most commonly employed is the Platelet-Rich Plasma that is not entirely natural. It involves the use of non-autologous anticoagulants such as bovine thrombin to maintain the fluid consistency which prevents clot formation and thus impairs wound healing, affects the coagulation process and can also trigger an immune reaction, thereby, suppressing regeneration.
PRP offers a short-term release of most of the growth factors unlike the Platelet-Rich Fibrin which allows for a more sustained release. PRF does not require any biochemical handling of blood and is easy to procure but due to the gel-like consistency, its adaptability within the root canal requires excessive removal of root dentin.
In addition, the application of recombinant growth factors within the root canal is associated with high cost which hinders its applicability in the common clinical practice.
Therefore, a new regenerative technique is required that combines the advantages of both PRP and PRF while overcoming their drawbacks.
- Conditions
- Necrotic Pulp
- Being tested
- Injectable platelet-rich fibrin, Platelet-rich plasma
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injectable platelet-rich fibrinProcedure or surgery
A blood sample will be drawn from the patient, centrifuged at 700 rpm for 3 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal.
Platelet-rich plasmaProcedure or surgery
A blood sample will be drawn from the patient, centrifuged at 3000 rpm for 10 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal.
| Study group | Role | What they receive |
|---|---|---|
| Injectable platelet-rich fibrin | Experimental | A platelet concentrate will be prepared from the patient's own blood in plain plastic tubes, without the use of anticoagulants, and applied immediately within the root canal before coagulation. Receives: Procedure: Injectable platelet-rich fibrin |
| Platelet-rich plasma | Active comparator | A platelet concentrate will be prepared from the patient's own blood in tubes containing anticoagulants to maintain the fluid consistency and applied within the root canal. Receives: Procedure: Platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in root length
root length will be measured on the preoperative and postoperative radiographs and the percentage increase in length will be calculated
Measured: one year follow-up
Secondary outcomes (1)
Restoration of tooth sensitivity
sensitivity will be measured by an electric pulp tester
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study startNov 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Necrotic PulpStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mohamed Abou-Heikal, Cairo University
- Investigators
- Jealane El-Shafei, PhD, Study director, Professor Doctor of Endodontics, Faculty of Dentistry, Cairo University.Samia Shouman, PhD, Study director, Professor Doctor of Medical Biochemistry, National Cancer Institute, Cairo UniversityNehal Nabil, PhD, Study director, Lecturer of Endodontics, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698188
- Sponsor's protocol ID
- 11888
- Status last verified
- Oct 2018
- First submitted
- 3 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.
PubMed 30003342Karde PA, Sethi KS, Mahale SA, Khedkar SU, Patil AG, Joshi CP. Comparative evaluation of platelet count and antimicrobial efficacy of injectable platelet-rich fibrin with other platelet concentrates: An in vitro study. J Indian Soc Periodontol. 2017 Mar-Apr;21(2):97-101. doi: 10.4103/jisp.jisp_201_17.
PubMed 29398852Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Effects of an injectable platelet-rich fibrin on osteoblast behavior and bone tissue formation in comparison to platelet-rich plasma. Platelets. 2018 Jan;29(1):48-55. doi: 10.1080/09537104.2017.1293807. Epub 2017 Mar 29.
PubMed 28351189Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
PubMed 28154995
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Injectable Platelet-Rich Fibrin Versus Platelet-Rich Plasma in the Regeneration of Necrotic Immature Maxillary Anterior Teeth. (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT03698188
- Acronym / sponsor ID
- 11888
- Conditions
- Necrotic Pulp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Oct 2018 (actual)
- 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.
Injectable platelet-rich fibrin (I-PRF) is a flowable blood concentrate that is entirely natural and allows ease of access and flow within the root canal. It was first developed in 2014 by modifying the centrifugation parameters. I-PRF has great potential in the field of endodontics. At present, it is still in its infancy and needs to be explored with regard to its regenerative efficacy.
To the best of our knowledge, this study is the first to clinically and comparatively investigate Platelet-rich plasma (PRP) and I-PRF.
Detailed description
An ideal treatment option for an immature necrotic tooth is the regeneration of pulp-like tissue that is capable of boosting the continuation of normal root development. The use of platelet concentrates for that purpose is a clinically relevant, minimally invasive approach which has a promising potential of reducing the healing period. Among which, the most commonly employed is the Platelet-Rich Plasma that is not entirely natural. It involves the use of non-autologous anticoagulants such as bovine thrombin to maintain the fluid consistency which prevents clot formation and thus impairs wound healing, affects the coagulation process and can also trigger an immune reaction, thereby, suppressing regeneration.
PRP offers a short-term release of most of the growth factors unlike the Platelet-Rich Fibrin which allows for a more sustained release. PRF does not require any biochemical handling of blood and is easy to procure but due to the gel-like consistency, its adaptability within the root canal requires excessive removal of root dentin.
In addition, the application of recombinant growth factors within the root canal is associated with high cost which hinders its applicability in the common clinical practice.
Therefore, a new regenerative technique is required that combines the advantages of both PRP and PRF while overcoming their drawbacks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injectable platelet-rich fibrin | Experimental | Procedure: Injectable platelet-rich fibrinA platelet concentrate will be prepared from the patient's own blood in plain plastic tubes, without the use of anticoagulants, and applied immediately within the root canal before coagulation. |
| Platelet-rich plasma | Active comparator | Procedure: Platelet-rich plasmaA platelet concentrate will be prepared from the patient's own blood in tubes containing anticoagulants to maintain the fluid consistency and applied within the root canal. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients having necrotic maxillary anterior tooth/teeth due to caries or trauma
- Radiographic criteria: preoperative radiograph showing incomplete root formation with a wide apical foramen.
- Positive patient/guardian compliance for participation in the study.
Key exclusion criteria (8 listed)
- Uncooperative patient
- Lack of patient commitment to the treatment plan and the follow-up period
- Mature necrotic anterior teeth due to caries or trauma
- Vital maxillary anterior teeth with open apices
- Non-restorable teeth
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 |
|---|---|---|
| Injectable platelet-rich fibrinA blood sample will be drawn from the patient, centrifuged at 700 rpm for 3 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal. | Procedure or surgery | Injectable platelet-rich fibrin |
| Platelet-rich plasmaA blood sample will be drawn from the patient, centrifuged at 3000 rpm for 10 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal. | Procedure or surgery | Platelet-rich plasma |
Primary outcome
Increase in root length
Time frame: one year follow-up
root length will be measured on the preoperative and postoperative radiographs and the percentage increase in length will be calculated
1 secondary outcome
Restoration of tooth sensitivity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 30003342Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.
- Background: PubMed 29398852Karde PA, Sethi KS, Mahale SA, Khedkar SU, Patil AG, Joshi CP. Comparative evaluation of platelet count and antimicrobial efficacy of injectable platelet-rich fibrin with other platelet concentrates: An in vitro study. J Indian Soc Periodontol. 2017 Mar-Apr;21(2):97-101. doi: 10.4103/jisp.jisp_201_17.
- Background: PubMed 28351189Wang X, Zhang Y, Choukroun J, Ghanaati S, Miron RJ. Effects of an injectable platelet-rich fibrin on osteoblast behavior and bone tissue formation in comparison to platelet-rich plasma. Platelets. 2018 Jan;29(1):48-55. doi: 10.1080/09537104.2017.1293807. Epub 2017 Mar 29.
- Background: PubMed 28154995Miron RJ, Fujioka-Kobayashi M, Hernandez M, Kandalam U, Zhang Y, Ghanaati S, Choukroun J. Injectable platelet rich fibrin (i-PRF): opportunities in regenerative dentistry? Clin Oral Investig. 2017 Nov;21(8):2619-2627. doi: 10.1007/s00784-017-2063-9. Epub 2017 Feb 2.
- Individual participant dataSharing planned: No
Related trials for Necrotic Pulp
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
Not yet recruiting
Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
Necrotic Pulps With no Apical Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
Pulp Necrosis, Apical Periodontitis
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.
Jealane El-Shafei, PhD study director
Professor Doctor of Endodontics, Faculty of Dentistry, Cairo University.
Samia Shouman, PhD study director
Professor Doctor of Medical Biochemistry, National Cancer Institute, Cairo University
Nehal Nabil, PhD study director
Lecturer of Endodontics, Faculty of Dentistry, Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Injectable platelet-rich fibrin and Platelet-rich plasma in people with Necrotic Pulp, run by Cairo University.
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 8 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: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Abo Heikal, Msc (01110704077, mh.haikal2008@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in root length (time frame: one year follow-up). 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 NCT03698188, which also lists 4 linked publications.
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 25 Oct 2018.