Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

Study Overview
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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.

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.

Official Title
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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)

Conditions
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Necrotic Pulp

Intervention / Treatment
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* Procedure: Injectable platelet-rich fibrin
* Procedure: Platelet-rich plasma


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injectable platelet-rich fibrin<br>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. | Procedure: Injectable platelet-rich fibrin<br>* 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.<br>|
| Active Comparator: Platelet-rich plasma<br>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. | Procedure: Platelet-rich plasma<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of tooth sensitivity | sensitivity will be measured by an electric pulp tester | one year |