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Root coverage with platelet-rich fibrin or connective tissue graft: a split-mouth randomized trial
Carrera, T. M. I., Machado, L. M., Soares, M. T. R., Passos, G. P., Oliveira, G. J. P., Ribeiro Júnior, N. V., Soares, P. B. F., Pigossi, S. C.
Brazilian oral research. 2023;37:e084
Abstract
This study aimed to compare the use of connective tissue grafts (CTG) and platelet-rich fibrin (PRF) associated with the tunnel technique (TT) for the treatment of multiple gingival recessions (GR). Fourteen patients with multiple bilateral GR [type 1 recession (RT 1)] in the maxillary incisors, canines, and/or premolars were included. The TT was performed on both sides (split-mouth model); CTG (36 GR) was used on one side, and on the other, PRF (36 GR) was used. Clinical parameters, including recession depth (RD), probing depth, clinical attachment level (CAL), and keratinized gingiva thickness/width (GT/KTW), were obtained at baseline and after 1, 3, 6, and 16 months. Lower RD (0.81 ± 0.68 vs. 1.23 ± 0.71 mm) and CAL (2.54 ± 0.63 vs. 2.73 ± 0.82 mm) were observed for CTG compared to PRF after 16 months. Higher GT was obtained for CTG compared to PRF after 3 (1.81 ± 0.56 vs 1.43 ± 0.47 mm) and 6 months (1.67 ± 0.61 vs. 1.38 ± 0.55 mm, p < 0.05). The recession coverage (RC) was higher for CTG (55.42% ± 37.14) in comparison to PRF (29.53% ± 34.08) after 16 months (p < 0.05). Similarly, CTG presented a more complete coverage of the recession (15; 41.66%) than PRF (9; 24.32%). There were no significant differences between the groups in terms of surgery time, postoperative pain, or healing patterns. Greater esthetic satisfaction was obtained with CTG. It was concluded that CTG combined with TT showed clinical and esthetic results superior to those of PRF in multiple GR treatments.
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Comparison between platelet rich fibrin as space filling material versus xenograft and alloplastic bone grafting materials in immediate implant placement: a randomized clinical trial
Elsheikh, H. A., Abdelsameaa, S. E., Elbahnasi, A. A., Abdel-Rahman, F. H.
BMC oral health. 2023;23(1):977
Abstract
BACKGROUND This study aimed to compare the efficacy of different gap filling materials in immediate implant in anterior and premolar regions of maxilla. MATERIALS AND METHODS Thirty-six implants were inserted in patients seeking for replacement of non-restorable maxillary anterior and premolar teeth (esthetic zone) by immediate implant. Patients were randomly distributed into three equal groups, twelve implants in each group. Group 1 received Platelet Rich Fibrin (PRF) into the jumping distance, Group 2 received Xenograft into the jumping distance and Group 3 received Alloplastic bone grafting material into the jumping distance. Implant stability by measuring the changes in Resonance Frequency Analysis (RFA), peri-implant pocket depth, marginal bone loss and changes in buccal bone thickness were evaluated during follow up periods. All the clinical and radiographic data were subjected to statistical analysis by One Way ANOVA test and the Post Hoc Tukey test. RESULTS This study involved 19 female patients and 17 male patients who received 36 dental implants. There was no significant difference between the study groups regarding implant stability, peri-implant pocket depth and palatal bone loss, while there was a significant difference between PRF Group (Group 1) and the other Groups regarding buccal bone loss and changes in buccal bone thickness. CONCLUSION PRF can be used as a gap filling material in conjunction with immediate implant placement, but other bone grafting materials give superior result regarding buccal bone loss and changes in buccal bone thickness. TRIAL REGISTRATION The study was listed on www. CLINICALTRIALS gov with registration number (NCT05878392) on 26/05/2023. The Institutional Review Board (IRB) of the Faculty of Dentistry, Mansoura University, Mansoura, Egypt, approved the current study in compliance with the seventh revision of the Helsinki Declaration in 2013 (A0103023OS).
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Cryopreserved platelets compared with liquid-stored platelets for the treatment of surgical bleeding: protocol for two multicentre randomised controlled blinded non-inferiority trials (the CLIP-II and CLIPNZ-II trials)
Reade, M. C., Marks, D. C., Howe, B., McGuinness, S., Parke, R., Navarra, L., Charlewood, R., Johnson, L., McQuilten, Z.
BMJ open. 2022;12(12):e068933
Abstract
INTRODUCTION Cryopreservation at -80°C in dimethylsulphoxide extends platelet shelf-life from 7 days to 2 years. Only limited comparative trial data supports the safety and effectiveness of cryopreserved platelets as a treatment for surgical bleeding. Cryopreserved platelets are not currently registered for civilian use in most countries. METHODS AND ANALYSIS CLIP-II and CLIPNZ-II are harmonised, blinded, multicentre, randomised, controlled clinical non-inferiority trials comparing bleeding, transfusion, safety and cost outcomes associated with cryopreserved platelets versus conventional liquid platelets as treatment for bleeding in cardiac surgery. CLIP-II is planning to enrol patients in 12 tertiary hospitals in Australia; CLIPNZ-II will recruit in five tertiary hospitals in New Zealand. The trials use near-identical protocols aside from details of cryopreserved platelet preparation. Patients identified preoperatively as being at high risk of requiring a platelet transfusion receive up to three units of study platelets if their treating doctor considers platelet transfusion is indicated. The primary endpoint is blood loss through the surgical drains in the 24 hours following intensive care unit (ICU) admission after surgery. Other endpoints are blood loss at other time points, potential complications, adverse reactions, transfusion and fluid requirement, requirement for procoagulant treatments, time to commencement of postoperative anticoagulants, delay between platelet order and commencement of infusion, need for reoperation, laboratory and point-of-care clotting indices, cost, length of mechanical ventilation, ICU and hospital stay, and mortality. Transfusing 202 (CLIP-II) or 228 (CLIPNZ-II) patients with study platelets will provide 90% power to exclude the possibility of greater than 20% inferiority in the primary endpoint. If cryopreserved platelets are not inferior to liquid-stored platelets, the advantages of longer shelf-life would justify rapid change in clinical practice. Cost-effectiveness analyses will be incorporated into each study such that, should clinical non-inferiority compared with standard care be demonstrated, the hospitals in each country that would benefit most from changing to a cryopreserved platelet blood bank will be known. ETHICS AND DISSEMINATION CLIP-II was approved by the Austin Health Human Research Ethics Committee (HREC/54406/Austin-2019) and by the Australian Red Cross Lifeblood Ethics Committee (2019#23). CLIPNZ-II was approved by the New Zealand Southern Health and Disability Ethics Committee (21/STH/66). Eligible patients are approached for informed consent at least 1 day prior to surgery. There is no provision for consent provided by a substitute decision-maker. The results of the two trials will be submitted separately for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS NCT03991481 and ACTRN12621000271808.
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A Pilot Trial of Platelets Stored Cold versus at Room Temperature for Complex Cardiothoracic Surgery
Strandenes G, Sivertsen J, Bjerkvig CK, Fosse TK, Cap AP, Del Junco DJ, Kristoffersen EK, Haaverstad R, Kvalheim V, Braathen H, et al
Anesthesiology. 2020
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Abstract
BACKGROUND This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials. METHODS A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality. RESULTS In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature-stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature- and cold-stored up to 7 days arm was 75 ml (95% CI, -220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, -1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature- and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets. CONCLUSIONS This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients.
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Use of thrombin generation test for monitoring hemostasis in coronary bypass surgery
Gruzdeva O, Uchasova E, Fanaskova E, Akbasheva O, Penskaya T, Plotnikov G, Dyleva Y, Barbarash O
Clinical Hemorheology and Microcirculation. 2017;66((1):):57-66
Abstract
To evaluate the parameters of the thrombin generation test (TGT) in coronary artery disease (CAD) patients on prolonged aspirin therapy during on-pump coronary artery bypass grafting (CABG) after donor platelet concentrate transfusion. A total of 148 patients with CAD on prolonged aspirin therapy (75-100 mg/day) who have undergone elective on-pump CABG were consecutively included in the study. Patients were divided randomly into two groups. Group 1 (n = 76) received donor platelet transfusions after cardiopulmonary bypass, whereas Group 2 (n = 72) did not. TGT parameters were measured using an analyzer at pre-, intra-, and early postoperative periods. Activation of the endogenous thrombin potential was observed in patients on prolonged aspirin therapy in the pre- and intraoperative periods, as confirmed by high peak thrombin and increased velocity index. The activation time of the prothrombinase complex and thrombin generation time were greater than the control group. The blood hemostatic potential in patients who did not receive transfusions in the early postoperative period decreased up to the level of the control group in the extended time parameters. Hemostatic potential in plasma in patients on aspirin was preserved. Given the laboratory test results and clinical data, platelet concentrate transfusion is unnecessary for prevention.
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No positive effect of autologous platelet gel after total knee arthroplasty: a double-blind randomized controlled trial: 102 patients with a 3-month follow-up
Peerbooms JC, De Wolf GS, Colaris JW, Bruijn DJ, Verhaar JAN
Acta Orthopaedica. 2009;80((5):):557-62.
Abstract
Background and purpose: Activated platelets release a cocktail of growth factors, some of which are thought to stimulate repair. We investigated whether the use of autologous platelet gel (PG) in total knee arthroplasty (TKA) would improve wound healing and knee function, and reduce blood loss and the use of analgesics. Patients and methods: 102 patients undergoing TKA were randomly assigned to a PG group (n 50) or to a control (C) group (n 52). The primary analysis was based on 73 participants (PG: 32; C: 41) with comparison of postoperative wound scores, VAS, WOMAC, knee function, use of analgesics, and the pre- and postoperative hemoglobin values after a follow-up of 3 months. 29 participants were excluded due to insufficient data. Results: The characteristics of the protocol-compliant patients were similar to those of the patients who were excluded. Analysis was per protocol and focused on the remaining 73 patients. At baseline and after 3 months of follow-up, there were no statistically significant differences between both groups regarding age, height, weight, sex, side of operation, platelet count, hemoglobin values, severity of complaints (WOMAC), and level of pain. Interpretation In our patients undergoing TKA, application of PG to the wound site did not promote wound healing. Also, we found that PG had no effect on pain, knee function, or hemoglobin values. copyright 2009 Nordic Orthopedic Federation. Copyright © 2011 Elsevier B. V. , Amsterdam. All Rights Reserved.
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Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty
Zavadil DP, Satterlee CC, Costigan JM, Holt DW, Shostrom VK
The Journal of Extra-Corporeal Technology. 2007;39((3):):177-82.
Abstract
The recovery of patients undergoing total shoulder arthroplasty (TSA) can be adversely affected by a number of complications. Autologous platelet gel (APG), produced by activating platelet-rich plasma (PRP), has been shown to improve hemostasis and wound healing and reduce infections in some surgical procedures. Activated platelet-poor plasma (PPP) has also been used as a hemostatic agent. This study examines the effects of APG and PPP treatment on TSA patients postoperatively. After Institutional Review Board (IRB) approval, 40 patients undergoing TSA at our institution were prospectively enrolled in our study. They were randomized into either a control (n = 20) or study (n = 20) group, with the study group receiving APG and PPP treatment. Preoperative demographic data, pre- and postoperative laboratory data, pain scores, pain medication, complications, pre- and postoperative range of motion measurements, and postoperative lengths of stay were recorded for each group. The preoperative internal rotation index was significantly higher in the control group compared with treatment patients (4. 64 +/- 4. 46 vs. 1. 88 +/- 2. 44, p < . 05). The percent hemoglobin retained postoperatively was higher in the treatment group at 24 (84. 54 +/- 5. 32 vs. 79. 87 +/- 8. 73) and 72 hours (87. 46 +/- 16. 03 vs. 76. 70 vs. 5. 96), but neither difference reached statistical significance. The treatment group had significantly lower pain scores (p = . 007) and total fentanyl requirements (p < . 05) compared with control patients. The internal rotation index improvement factor (postoperative internal rotation index/preoperative internal rotation index) was significantly higher in the treatment group vs. the control group (p < . 05). Although it did not reach statistical significance, the treatment group was discharged almost 9 hours earlier than the control group (64. 44 +/- 15. 23 vs. 73. 39 +/- 15. 37). APG and PPP treatment decreased pain and provided a greater increase in internal rotation measurements postoperatively.
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Autologous platelet gel applications during cardiovascular surgery: effect on wound healing
Englert SJ, Estep TH, Ellis-Stoll CC
The Journal of Extra-Corporeal Technology. 2005;37((2):):148-52.
Abstract
Autologous platelet gel (APG) was developed in the early 1990s as a byproduct of platelet-rich plasma sequestration during cardiac surgery. Although APG has been approved for postoperative healing, there have been no published studies that evaluate the effects of APG on sternal healing postcardiopulmonary bypass. The purpose for this study was to examine the effects of APG on postoperative sternal wound healing evidenced by subjective reports of chest and leg pain, the amount of measurable bruising incurred, and platelet indices both preoperatively and postoperatively.
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Comparison of the effects of transfusions of cryopreserved and liquid-preserved platelets on hemostasis and blood loss after cardiopulmonary bypass
Khuri SF, Healey N, MacGregor H, Barnard MR, Szymanski IO, Birjiniuk V, Michelson AD, Gagnon DR, Valeri CR
Journal of Thoracic & Cardiovascular Surgery. 1999;117((1):):172-83; discussion 183-4.
Abstract
OBJECTIVE The aim of the study was to compare the clinical effects and hemostatic efficiency of transfusions of platelets preserved in the frozen state for as long as 2 years with transfusions of platelets preserved in the conventional manner for as long as 5 days in patients undergoing cardiopulmonary bypass. METHODS Seventy-three patients were prospectively randomly assigned to receive transfusions of cryopreserved or liquid-preserved platelets. Nonsurgical blood loss was measured during and after the operation. Bleeding time, hematologic variables, and the bleeding time site shed blood were assayed before cardiopulmonary bypass and at 30 minutes and 2, 4, and 24 hours after transfusion. In vitro platelet function tests were conducted on platelets obtained from healthy volunteers. RESULTS No adverse sequelae of the transfusions were observed. Blood loss and the need for postoperative blood product transfusions were lower in the group receiving cryopreserved platelets. Lower posttransfusion platelet increments and a tendency toward decreased platelet survival were observed in patients receiving cryopreserved platelets. Hematocrit and plasma fibrinogen were significantly higher in this group, and the duration of intubation was shorter. In vitro, cryopreserved platelets demonstrated less aggregation, lower pH, and decreased response to hypotonic stress but generated more procoagulant activity and thromboxane. CONCLUSIONS (1) Cryopreserved platelet transfusions are superior to liquid-preserved platelets in reducing blood loss and the need for blood product transfusions after cardiopulmonary bypass. (2) The reduction in blood loss in the patients receiving cryopreserved platelet transfusions after cardiopulmonary bypass probably reflects improved in vivo hemostatic function of cryopreserved platelets. (3) Some in vitro measures of platelet quality (aggregation, pH, hypotonic stress) may not reflect in vivo quality of platelet transfusions after cardiopulmonary bypass, whereas other in vitro measures (platelet procoagulant activity and thromboxane) do.