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Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Primary Purpose

Necrotic Pulp

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Injectable platelet-rich fibrin
Platelet-rich plasma
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrotic Pulp

Eligibility Criteria

10 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Injectable platelet-rich fibrin

    Platelet-rich plasma

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Restoration of tooth sensitivity
    sensitivity will be measured by an electric pulp tester

    Full Information

    First Posted
    October 3, 2018
    Last Updated
    October 24, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03698188
    Brief Title
    Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2018 (Anticipated)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Necrotic Pulp

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Injectable platelet-rich fibrin
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Platelet-rich plasma
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Injectable platelet-rich fibrin
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Platelet-rich plasma
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Increase in root length
    Description
    root length will be measured on the preoperative and postoperative radiographs and the percentage increase in length will be calculated
    Time Frame
    one year follow-up
    Secondary Outcome Measure Information:
    Title
    Restoration of tooth sensitivity
    Description
    sensitivity will be measured by an electric pulp tester
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maha Abo Heikal, Msc
    Phone
    01110704077
    Email
    mh.haikal2008@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jealane El-Shafei, PhD
    Organizational Affiliation
    Professor Doctor of Endodontics, Faculty of Dentistry, Cairo University.
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Samia Shouman, PhD
    Organizational Affiliation
    Professor Doctor of Medical Biochemistry, National Cancer Institute, Cairo University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Nehal Nabil, PhD
    Organizational Affiliation
    Lecturer of Endodontics, Faculty of Dentistry, Cairo University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30003342
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29398852
    Citation
    Karde 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.
    Results Reference
    background
    PubMed Identifier
    28351189
    Citation
    Wang 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.
    Results Reference
    background
    PubMed Identifier
    28154995
    Citation
    Miron 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.
    Results Reference
    background

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    Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

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