Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03698188
Collaborator
(none)
24
2
18

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Injectable platelet-rich fibrin
  • Procedure: Platelet-rich plasma
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Anticipated Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
May 1, 2019
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

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.

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Increase in root length [one year follow-up]

    root length will be measured on the preoperative and postoperative radiographs and the percentage increase in length will be calculated

Secondary Outcome Measures

  1. Restoration of tooth sensitivity [one year]

    sensitivity will be measured by an electric pulp tester

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

  • Study Director: Jealane El-Shafei, PhD, Professor Doctor of Endodontics, Faculty of Dentistry, Cairo University.
  • Study Director: Samia Shouman, PhD, Professor Doctor of Medical Biochemistry, National Cancer Institute, Cairo University
  • Study Director: Nehal Nabil, PhD, Lecturer of Endodontics, Faculty of Dentistry, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Maha Mohamed Abou-Heikal, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT03698188
Other Study ID Numbers:
  • 11888
First Posted:
Oct 5, 2018
Last Update Posted:
Oct 25, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2018