Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

NCT03698188 | Unknown

• 1 other identifier: 11888
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Necrotic Pulp

Outcome Measures

Primary Outcomes (1)

• Increase in root length

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

  one year follow-up

Secondary Outcomes (1)

• Restoration of tooth sensitivity

  one year

Study Arms (2)

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.

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.

Procedure: Platelet-rich plasma

Interventions

Injectable platelet-rich fibrin PROCEDURE

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.

Injectable platelet-rich fibrin

Platelet-rich plasma PROCEDURE

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.

Platelet-rich plasma

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Related Publications (4)

• 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.

  PMID: 30003342 BACKGROUND

• 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.

  PMID: 29398852 BACKGROUND

• 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.

  PMID: 28351189 BACKGROUND

• 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.

  PMID: 28154995 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 DIRECTOR

Central Study Contacts

Maha Abo Heikal, Msc

CONTACT

01110704077; mh.haikal2008@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: November 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 25, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share