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
About this trial
This is an interventional treatment trial for Necrotic Pulp
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
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
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
Learn more about this trial
Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates
We'll reach out to this number within 24 hrs