Skip to content

Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

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)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03698188
Enrollment
24
Registered
2018-10-05
Start date
2018-11-30
Completion date
2020-05-31
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotic Pulp

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.

Interventions

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.

PROCEDUREPlatelet-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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 25 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Increase in root lengthone year follow-uproot length will be measured on the preoperative and postoperative radiographs and the percentage increase in length will be calculated

Secondary

MeasureTime frameDescription
Restoration of tooth sensitivityone yearsensitivity will be measured by an electric pulp tester

Contacts

Primary ContactMaha Abo Heikal, Msc
mh.haikal2008@gmail.com01110704077

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026