Clinical trial NCT03698188: Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotic Pulp
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 24
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Increase in root length
timeFrame: one year follow-up
Secondary outcomes:
measure: Restoration of tooth sensitivity
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Professor Doctor of Endodontics, Faculty of Dentistry, Cairo University.
name: Jealane El-Shafei, PhD
role: STUDY_DIRECTOR
affiliation: Professor Doctor of Medical Biochemistry, National Cancer Institute, Cairo University
name: Samia Shouman, PhD
role: STUDY_DIRECTOR
affiliation: Lecturer of Endodontics, Faculty of Dentistry, Cairo University
name: Nehal Nabil, PhD
role: STUDY_DIRECTOR
References:
citation: Varela HA, Souza JCM, Nascimento RM, Araujo RF Jr, Vasconcelos RC, Cavalcante RS, Guedes PM, Araujo AA. Injectable platelet rich fibrin: cell content, morphological, and protein characterization. Clin Oral Investig. 2019 Mar;23(3):1309-1318. doi: 10.1007/s00784-018-2555-2. Epub 2018 Jul 12.
citation: 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.
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.
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.