Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Necrotic Pulp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Injectable platelet-rich fibrin

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.

Group Type EXPERIMENTAL

Injectable platelet-rich fibrin

Intervention Type 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.

Platelet-rich plasma

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.

Group Type ACTIVE_COMPARATOR

Platelet-rich plasma

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes