Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Cairo University (CU)

Status: Unknown

Conditions: Necrotic Pulp

Treatments: Procedure: Injectable platelet-rich fibrin; Procedure: Platelet-rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT03698188

11888

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 10 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Injectable platelet-rich fibrin

Experimental group

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.

Treatment:

Procedure: Injectable platelet-rich fibrin

Platelet-rich plasma

Active Comparator group

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.

Treatment:

Procedure: Platelet-rich plasma