Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Maha Mohamed Abou-Heikal，Cairo University

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 2018

Estimated Primary Completion Date

May 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Restoration of tooth sensitivity[ Time Frame: one year ]
sensitivity will be measured by an electric pulp tester

Descriptive Information

Brief Title ^ICMJE

Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Official Title ^ICMJE

Evaluation of the Efficacy of Injectable Platelet-Rich Fibrin Versus Platelet-Rich Plasma in the Management of Necrotic Immature Maxillary Anterior Teeth. (A Randomized Clinical Trial)

Brief 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. 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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Injectable platelet-rich fibrin
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.
Procedure: Platelet-rich plasma
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 Arms

Experimental: Injectable platelet-rich fibrin
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.
Active Comparator: Platelet-rich plasma
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.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 2020

Estimated Primary Completion Date

May 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

7 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Maha Mohamed Abou-Heikal，Cairo University

Study Sponsor ^ICMJE

Cairo University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Jealane El-Shafei, PhD Professor Doctor of Endodontics, Faculty of Oral and Dental medicine, Cairo University.
Study Director: Nihal Nabil, PhD Lecturer of Endodontics, Faculty of Oral and Dental medicine, Cairo University.

PRS Account

Cairo University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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