scholarly journals The Platelet Concentrates Therapy: From the Biased Past to the Anticipated Future

2020 ◽  
Vol 7 (3) ◽  
pp. 82 ◽  
Author(s):  
Tomoyuki Kawase ◽  
Suliman Mubarak ◽  
Carlos Fernando Mourão
Keyword(s):  
Therapeutic Agent ◽  
Randomized Clinical Trials ◽  
Oral Surgery ◽  
Platelet Rich Plasma ◽  
Platelet Concentrates ◽  
Recent Past ◽  
Regulatory Authorities ◽  
Randomized Controlled ◽  
Real Nature ◽  
Design Bias

The ultimate goal of research on platelet concentrates (PCs) is to develop a more predictable PC therapy. Because platelet-rich plasma (PRP), a representative PC, was identified as a possible therapeutic agent for bone augmentation in the field of oral surgery, PRP and its derivative, platelet-rich fibrin (PRF), have been increasingly applied in a regenerative medicine. However, a rise in the rate of recurrence (e.g., in tendon and ligament injuries) and adverse (or nonsignificant) clinical outcomes associated with PC therapy have raised fundamental questions regarding the validity of the therapy. Thus, rigorous evidence obtained from large, high-quality randomized controlled trials must be presented to the concerned regulatory authorities of individual countries or regions. For the approval of the regulatory authorities, clinicians and research investigators should understand the real nature of PCs and PC therapy (i.e., adjuvant therapy), standardize protocols of preparation (e.g., choice of centrifuges and tubes) and clinical application (e.g., evaluation of recipient conditions), design bias-minimized randomized clinical trials, and recognize superfluous brand competitions that delay sound progress. In this review, we retrospect the recent past of PC research, reconfirm our ultimate goals, and discuss what will need to be done in future.

Use of Platelet-Rich Plasma and Platelet-Rich Fibrin in Dentistry and Oral Surgery: Introduction and Review of the Literature

2019 ◽  
Vol 36 (2) ◽  
pp. 109-123 ◽  
Author(s):  
Kristina Feigin ◽  
Bonnie Shope
Keyword(s):  
Soft Tissues ◽  
Oral Surgery ◽  
Platelet Rich Plasma ◽  
Maxillofacial Surgery ◽  
Oral And Maxillofacial Surgery ◽  
Platelet Concentrates ◽  
Platelet Rich Fibrin ◽  
Wide Range ◽  
Comprehensive Examination ◽  
And Function

Platelet concentrates, mostly represented by platelet-rich plasma and platelet-rich fibrin, have gained significant interest in various medical and oral disciplines because of their potential to stimulate and boost regeneration of hard and soft tissues. Prepared from the patient’s own blood, they have been tested and used in various different surgical fields including oral and maxillofacial surgery. The effects of these biomaterials are described to be a result of the large concentration of platelets which contain a wide range of growth factors. The aim of this article is to introduce the principle and function of these platelet concentrates, to review their preparation, and to provide a comprehensive examination of the published oral and maxillofacial literature on this subject.

scholarly journals The Clinical Application Of Platelet Concentrates: A Systematic Meta-analysis

2015 ◽  
Vol 5 (1) ◽  
pp. 21-26
Author(s):  
Sneha Ketan Gada
Keyword(s):  
Clinical Application ◽  
Oral Surgery ◽  
Therapeutic Potential ◽  
Platelet Rich Plasma ◽  
Meta Analysis ◽  
Pediatric Dentistry ◽  
Platelet Concentrates ◽  
Bone Contact ◽  
Platelet Rich Fibrin ◽  
Regenerative Dentistry

ABSTRACT Background Autologous plasma rich in platelets is derived blood product whose uses in dentistry dates back to the 1990s and it has been gaining popularity ever since. Aim A systematic review of the available literature to determine the efficacy, safety and success of platelet concentrates in physiological systems as well as describing its vigilant use. Study design and methods A Medline search with keywords ‘platelet rich plasma dental’ further filtered using Boolean opera- tors (AND, OR, NOT) and combination of specific keywords as follows: ‘platelet rich fibrin’, ‘platelet rich plasma regenerative’, ‘platelet rich plasma periodontal’, ‘platelet rich plasma extraction’ with a custom range of 10 years was performed, which yielded 88 results out of which 32 were selected based on the inclusion criteria. Results Significantly, successful outcomes have been wit- nessed in the field of osteoregeneration though it has been evidenced that adequate platelet rich plasma (PrP) additives are essential to bear a therapeutic potential. Favoring blood cell adhesion on the root surface optimizing periodontal healing, PrP has also shown positive effect on gingival repair; though controversial facts have also been reported. In the scope of implant dentistry, PrP has also reported greater implant-bone contact when used in both gel or liquid form. Emerging as a possible pulp capping agent along with properties of decreased chances root growth, PrP has successfully completed apexo- genesis in cases of pulpotomy.   Research has shown that although clinical results from the comparison of PrP alone vs PrP and resorbable membrane or various graft materials has shown a varied results, additional research in the field is needed. Conclusion Platelet rich plasma has shown promising results in the field of regenerative dentistry, with high success rate in implantology, periodontology and oral surgery. Because of conflicting success rates reported in literature further research is warrented. Clinical implication Platelet rich fibrin has displayed various features of rapid clinical healing, excellent bone density, less surgical time, less resorption during healing and decreased postoperative pain, as compared to guided bone regeneration procedures. Platelet rich plasma has also shown a myriad of applications ranging from hard tissue regeneration to soft tissue management, stretching across to the field of pediatric dentistry and endodontics. How to cite this article Gada SK, Gupta P. the Clinical Application of Platelet Concentrates: A Systematic Meta- analysis. Int J Prosthodont restor Dent 2015;5(1):21-26.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

scholarly journals Enhancing Patient Centricity and Advancing Innovation in Clinical Research with Virtual Randomized Clinical Trials (vRCTs)

Diagnostics ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 151
Author(s):  
Raphael A. Yaakov ◽  
Özgür Güler ◽  
Tim Mayhugh ◽  
Thomas E. Serena
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Randomized Clinical Trials ◽  
Regulatory Compliance ◽  
Small Sample ◽  
Controlled Trials ◽  
Holistic View ◽  
Health Crisis ◽  
Randomized Controlled ◽  
Healthcare Needs

The current public health crisis has highlighted the need to accelerate healthcare innovation. Despite unwavering levels of cooperation among academia, industry, and policy makers, it can still take years to bring a life-saving product to market. There are some obvious limitations, including lack of blinding or masking and small sample size, which render the results less applicable to the real world. Traditional randomized controlled trials (RCTs) are lengthy, expensive, and have a low success rate. There is a growing acknowledgement that the current process no longer fully meets the growing healthcare needs. Advances in technology coupled with proliferation of telehealth modalities, sensors, wearable and connected devices have paved the way for a new paradigm. Virtual randomized controlled trials (vRCTs) have the potential to drastically shorten the clinical trial cycle while maximizing patient-centricity, compliance, and recruitment. This new approach can inform clinical trials in real time and with a holistic view of a patient’s health. This paper provides an overview of virtual clinical trials, addressing critical issues, including regulatory compliance, data security, privacy, and ownership.

Efficacy of Adjuvant Application of Platelet-Rich Plasma After Needle Aspiration of Calcific Deposits for the Treatment of Rotator Cuff Calcific Tendinitis: A Double-Blinded, Randomized Controlled Trial With 2-Year Follow-up

2021 ◽  
Vol 49 (4) ◽  
pp. 873-882
Author(s):  
Bart W. Oudelaar ◽  
Rianne Huis In ‘t Veld ◽  
Edwin M. Ooms ◽  
Relinde Schepers-Bok ◽  
Rob G.H.H. Nelissen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Rotator Cuff ◽  
Mixed Model ◽  
Platelet Rich Plasma ◽  
Controlled Trial ◽  
Needle Aspiration ◽  
Randomized Controlled ◽  
Clinical Scores ◽  
Calcific Deposits

Background: Needle aspiration of calcific deposits (NACD) is a frequently used treatment for rotator cuff calcific tendinitis (RCCT). However, a substantial number of patients experience recurrent or persisting shoulder symptoms after NACD. Purpose: To compare the effects of adjuvant application of platelet-rich plasma (PRP) after NACD (NACP+PRP) with those of conventional NACD with corticosteroids (NACD+corticosteroids) on pain, shoulder function, and quality of life (QoL). Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In a single-center, double-blinded, randomized controlled trial, 80 adults with symptomatic RCCT were randomly allocated to receive NACD+corticosteroids or NACD+PRP. Pain, shoulder function, and QoL were assessed at baseline; 6 weeks; and 3, 6, 12, and 24 months after treatment using a numeric rating scale for pain (NRS); the Constant-Murley score (CMS); the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH); the Oxford Shoulder Score (OSS); and the EuroQol 5-dimension scale (EQ-5D). Additionally, resorption of calcific deposits and the integrity of rotator cuff tendons were assessed by using standard radiographs and ultrasound examination, respectively. The results were analyzed using noninferiority analysis for NRS scores and a mixed model for repeated measures. Results: Eighty patients were included (48 female; mean age, 49 ± 6 years; 41 patients in the NACD+PRP group). Both groups showed improvement of clinical scores at the 2-year follow-up ( P < .001 for all clinical scores). NACD+PRP was found to be noninferior to NACD+corticosteroids with regard to the mean decrease of NRS scores (4.34 vs 3.56; P = .003). Mixed-model analysis showed a significant difference in favor of NACD+PRP (CMS, P < .001; DASH, P = .002; OSS, P = .010; EQ-5D, P < .001). However, clinically relevant differences in favor of NACD+PRP were only seen at the 6-month follow-up for NRS and CMS scores, whereas at the 6-week follow-up a clinically relevant difference in favor of NACD+corticosteroids was found for all clinical scores except for the NRS. Full resorption of calcific deposits was present in 84% of the NACD+PRP group compared with 66% in the NACD+corticosteroids group ( P = .081). In the NACD+PRP group, 10 (24%) patients required a second NACD procedure compared with 19 (49%) patients in the NACD+corticosteroids group ( P = .036). Six complications, of which 5 were frozen shoulders, occurred in the NACD+PRP group compared with 1 complication in the NACD+corticosteroids group ( P = .11). Conclusion: NACD+PRP resulted in worse clinical scores at the 6-week follow-up but better clinical scores at the 6-month follow-up compared with NACD+corticosteroids. At the 1- and 2-year follow-ups, the results were comparable between groups. Furthermore, PRP seemed to reduce the need for additional treatments but was associated with more complications. In conclusion, NACD+corticosteroids had a favorable early effect on pain and function combined with low comorbidity. Thus, it remains the treatment of choice for patients with RCCT. Registration: NCT02173743 (ClinicalTrials.gov identifier).

scholarly journals Non-operative orthobiologic use for rotator cuff disorders and glenohumeral osteoarthritis: A systematic review

2020 ◽  
pp. 1-16
Author(s):  
David M. Robinson ◽  
Christine Eng ◽  
Steven Makovitch ◽  
Joshua B. Rothenberg ◽  
Stephanie DeLuca ◽  
...  
Keyword(s):  
Systematic Review ◽  
Rotator Cuff ◽  
Cohort Studies ◽  
Randomized Clinical Trials ◽  
Platelet Rich Plasma ◽  
Inclusion Criteria ◽  
Serious Adverse Events ◽  
Bias Risk ◽  
Glenohumeral Osteoarthritis ◽  
Functional Outcome Measures

BACKGROUND: Shoulder pain from rotator cuff pathology and glenohumeral osteoarthritis is a common entity encountered in musculoskeletal practices. Orthobiologic agents are being increasingly used as a treatment option and understanding their safety and efficacy is necessary. OBJECTIVE: To systematically evaluate the available evidence for orthobiologic use in rotator cuff and glenohumeral pathology. METHODS: A systematic review was undertaken following PRISMA guidelines. Randomized clinical trials (RCTs) and prospective cohort studies evaluating non-operative treatment with prolotherapy, platelet-rich plasma (PRP), or medicinal signaling cells (MSCs) for rotator cuff pathology and glenohumeral osteoarthritis were included. Bias risk assessments used were the Cochrane tool and Newcastle-Ottawa score. RESULTS: The search yielded 852 potential articles, of which 20 met the inclusion criteria with a breakdown of 5 prolotherapy, 13 PRP, and 2 MSC. Sixteen studies were RCTs and 4 were cohort studies. Six studies were deemed “low risk of bias or good quality”. Efficacy results were mixed, and no serious adverse events were reported from orthobiologic treatment. CONCLUSIONS: Orthobiologics offer a relatively safe management option with inconclusive evidence for or against its use for rotator cuff pathology. No studies on glenohumeral osteoarthritis met the inclusion criteria. Adoption of standardized preparation reporting and consistent use of functional outcome measures is imperative for future studies to consider.

scholarly journals Characterizing Highly Benefited Patients in Randomized Clinical Trials

2017 ◽  
Vol 13 (1) ◽  
Author(s):  
Vivek Charu ◽  
Paul B. Rosenberg ◽  
Lon S. Schneider ◽  
Lea T. Drye ◽  
Lisa Rein ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Controlled Trial ◽  
New Method ◽  
Usual Model ◽  
Randomized Controlled ◽  
Working Model ◽  
Large Numbers ◽  
High Benefit ◽  
Two Stages

AbstractPhysicians and patients may choose a certain treatment only if it is predicted to have a large effect for the profile of that patient. We consider randomized controlled trials in which the clinical goal is to identify as many patients as possible that can highly benefit from the treatment. This is challenging with large numbers of covariate profiles, first, because the theoretical, exact method is not feasible, and, second, because usual model-based methods typically give incorrect results. Better, more recent methods use a two-stage approach, where a first stage estimates a working model to produce a scalar predictor of the treatment effect for each covariate profile; and a second stage estimates empirically a high-benefit group based on the first-stage predictor. The problem with these methods is that each of the two stages is usually agnostic about the role of the other one in addressing the clinical goal. We propose a method that characterizes highly benefited patients by linking model estimation directly to the particular clinical goal. It is shown that the new method has the following two key properties in comparison with existing approaches: first, the meaning of the solution with regard to the clinical goal is the same, and second, the value of the solution is the best that can be achieved when using the working model as a predictor, even if that model is incorrect. In the Citalopram for Agitation in Alzheimer’s Disease (CitAD) randomized controlled trial, the new method identifies substantially larger groups of highly benefited patients, many of whom are missed by the standard method.

scholarly journals Obtention of injectable platelets rich-fibrin (i-PRF) and its polymerization with bone graft: technical note

2015 ◽  
Vol 42 (6) ◽  
pp. 421-423 ◽  
Author(s):  
Carlos Fernando de Almeida Barros Mourão ◽  
Helder Valiense ◽  
Elias Rodrigues Melo ◽  
Natália Belmock Mascarenhas Freitas Mourão ◽  
Mônica Diuana-Calasans Maia
Keyword(s):  
Bone Graft ◽  
Platelet Rich Plasma ◽  
Technical Note ◽  
Platelet Concentrates ◽  
Soft Tissue Healing ◽  
Liquid Form ◽  
Platelet Rich Fibrin ◽  
Tissue Healing ◽  
Autologous Platelet ◽  
Injectable Form

The use of autologous platelet concentrates, represent a promising and innovator tools in the medicine and dentistry today. The goal is to accelerate hard and soft tissue healing. Among them, the platelet-rich plasma (PRP) is the main alternative for use in liquid form (injectable). These injectable form ofplatelet concentrates are often used in regenerative procedures and demonstrate good results. The aim of this study is to present an alternative to these platelet concentrates using the platelet-rich fibrin in liquid form (injectable) and its use with particulated bone graft materials in the polymerized form.

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