Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Necrotic Pulp Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03698188
• Other study ID #: 11888
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: May 2020

Study information

• Verified date: October 2018
• Source: Cairo University
• Contact: Maha Abo Heikal, Msc
• Phone: 01110704077
• Email: mh.haikal2008[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Necrotic Pulp

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (4)

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. — View 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. — View Citation

Varela HA, Souza JCM, Nascimento RM, Araújo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araújo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2018 Jul 12. doi: 10.1007/s00784-018-2555-2. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Restoration of tooth sensitivity	sensitivity will be measured by an electric pulp tester	one year