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Comparative histological evaluation of two PRF formulations (PRF High and PRF Medium) on quality of life and healing outcome of apicomarginal defects: A randomized clinical trial
Thakur V, Mittal S, Tewari S, Kamboj M, Duhan J, Sangwan P, Kumar V, Gupta A
Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery. 2023
Abstract
The objective of this randomized clinical trial was to investigate the effects of two PRF formulations (PRF High and PRF Medium) on quality of life and healing outcome (2D and 3D) of apicomarginal defects. Patients presenting with endodontic lesions and concomitant periodontal communication were randomly allocated to PRF High and PRF Medium groups. The treatment protocol in each group included a periapical surgical procedure with placement of PRF clot and membrane in the bony defect and on the denuded root surface, respectively. Quality of life was assessed for 1 week after surgery following a modified version of the patient's perception questionnaire. Postoperative pain was assessed using a visual analog scale. Clinical and radiographic evaluations were performed using Rud and Molven 2D criteria and Modified PENN 3D criteria. Buccal bone formation was assessed using sagittal and corresponding axial sections in CBCT. Histological analysis was performed using hematoxylin and eosin (H and E) staining and attaching primary antibodies to tissue sections. In total, 40 patients were enrolled in the trial (N = 20 per group). PRF Medium group patients reported significantly less swelling on the 1st (p = 0.036), 2nd (p = 0.034), and 3rd (p = 0.023) days, and average pain on the 2nd (p = 0.031), 3rd (p = 0.03), and 4th (p = 0.04) days postoperatively. The difference in success rate for periapical healing was non-significant between the PRF Medium group (89.5%) and PRF High group (90%), in both 2D and 3D imaging (p = 0.957). The formation of buccal bone was observed in five cases (26.3%) and four cases (20%) in the PRF Medium and PRF High groups, respectively, with a non-significant difference (p = 0.575). PRF Medium clots had a loose fibrin structure with a significantly higher number of neutrophils (473.79 ± 82.89 per mm(2)) than PRF High clots, which had a dense structure and fewer neutrophils (253.15 ± 63.86 per mm(2)) (p = 0.001). Autologous platelet concentrates (APCs) promoted satisfactory periapical healing, with no significant difference between the groups. Within the limitations of the study, it seems that PRF Medium should be preferred over PRF High when the patients' quality of life is the priority.
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2.
Comparative Efficacy of Platelet-Rich Plasma and Dry Needling for Management of Trigger Points in Masseter Muscle in Myofascial Pain Syndrome Patients: A Randomized Controlled Trial
Agarwal V, Gupta A, Singh H, Kamboj M, Popli H, Saroha S
Journal of oral & facial pain and headache. 2022
Abstract
AIMS: To compare the efficacy of platelet-rich plasma (PRP) injection vs dry needling (DN) for management of trigger points in the masseter muscle in myofascial pain syndrome (MPS) patients. METHODS This randomized controlled trial included 30 clinically confirmed cases of myofascial trigger points (MTrPs) in the masseter muscle who were randomly and equally (1:1) assigned to the test (PRP) and control (DN) groups. Both groups were evaluated for pain (visual analog scale [VAS]), range of functional movements, need for pain medication, patient satisfaction (Likert scale), and sleep (VAS) at baseline and 2-week, 1-month, and 3-month follow-ups. VAS pain and Likert score were also obtained at 6-month intervals. RESULTS The use of PRP solution in MTrPs in MPS patients had a better effect on pain and patient satisfaction compared to DN. CONCLUSION PRP appears to be a more effective treatment modality compared to DN in the management of MTrPs in MPS patients.
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3.
Efficacy of tranexamic acid in decreasing primary hemorrhage in transurethral resection of the prostate: A novel combination of intravenous and topical approach
Gupta A, Priyadarshi S, Vyas N, Sharma G
Urology annals. 2021;13(3):238-242
Abstract
BACKGROUND Transurethral resection of the prostate (TURP) is the gold standard for benign prostatic enlargement; however, hemorrhage still remains one of the major complications. OBJECTIVE The primary aim of this study was to evaluate the effect of tranexamic acid (TXA) in reducing intraoperative blood loss and need for blood transfusion. Secondary parameters compared were operating time, volume of irrigation fluid used, and reduction in hemoglobin concentration. SUBJECTS AND METHODS A total of 70 eligible patients undergoing TURP were randomized based on computer generated table into two groups. The study group (1) received IV TXA 500 mg after induction of anesthesia and 500 mg in each irrigation fluid bottle (dual mode) and the control group (2) received none. RESULTS The mean age (68.20 vs. 66.5 years), prostate size (57 vs. 51 g), and preoperative hemoglobin (13.3 vs. 13.5 g/dl) were similar between the groups. Intraoperative blood loss in the TXA group was found to be significantly reduced (174.60 ± 125.38 ml vs. 232.47 ± 116.8; P = 0.04). Blood transfusion was required in 2.8% of cases as compared to 14.2% in controls. Operating time, volume of irrigation fluid, and postoperative reduction of hemoglobin were not significant between the groups. No complications were observed in both groups. CONCLUSION In this study, we observed that TXA, when used as a combination of Intravenous and topical route, effectively reduced intra-operative blood loss and the need for transfusion.
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4.
Platelet-Rich Fibrin as an Aid to Soft- and Hard-Tissue Healing
Sharma R, Sharma P, Sharma SD, Chhabra N, Gupta A, Shukla D
Journal of maxillofacial and oral surgery. 2021;20(3):496-501
Abstract
INTRODUCTION Contemporary published data present confounding results on use of PRF in soft- and hard-tissue healing in the oral cavity, and many authors have suggested for further studies to reach the definitive conclusion. AIM: Our main objective therefore was to evaluate soft-tissue healing and osseous regeneration (by using VIXWIN PRO software) in extraction sites of mandibular third molars with substantial sample size to understand the effect of PRF in bony defects. METHODOLOGY Sixty patients had their bilaterally impacted third molars (120 sites) extracted in the split mouth study, following which platelet-rich fibrin was placed in one of the sockets. Patients were followed up clinically and radiographically, and pain score, presence of infection, exudation of graft and VIXWIN PRO software were used to evaluate healing of soft tissue and bone. RESULT AND CONCLUSION Our study advocates the use of PRF for enhanced soft- and hard-tissue healing. Though the osseous regeneration could be differentiated in both the groups at second month interval only, pain scores were better with PRF at most instances. Subsequent phase to the research should include histopathological investigations for ancillary support.
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5.
Efficacy of Intra-Lesional Platelet Rich Plasma in Diabetic Foot Ulcer
Gupta A, Channaveera C, Sethi S, Ranga S, Anand V
Journal of the American Podiatric Medical Association. 2020
Abstract
BACKGROUND Diabetic foot ulcer (DFU) is well managed by infection control, euglycemic state, debridement of ulcer followed by appropriate dressing and off-loading of the foot. Studies have reported that when DFU is properly off-loaded, about 90% of these would heal in nearly six weeks. Platelet rich plasma (PRP) serves as a growth factor agonist and has mitogenic and chemotactic properties which help in DFU healing. To evaluate the efficacy of local application of PRP with respect to healing rate and ulcer area reduction in treating diabetic foot ulcer. MATERIALS AND METHODS Sixty non-infected DFU patients with plantar ulcer of size less than 20cm2 and Wagner's Grade 1 & 2 were randomized to receive normal saline dressing (Control group - CG) or PRP dressing (Study group - SG) in conjunction with total contact casting for 6 weeks (or till complete ulcer healing), whichever was earlier. Evaluation was done at weekly interval for healing rate and change in ulcer area. RESULTS Mean ulcer area of study participants at baseline was 4.96 {plus minus} 2.89cm2 (CG) and 5.22 {plus minus} 3.82cm2 (SG) (p=0.77) which decreased to 1.15{plus minus}1.35cm2 (CG) and 0.96{plus minus}1.53cm2 (SG) (p=0.432) at 6wks. Percent reduction in mean healing area at 6wks was 81.72{plus minus}17.2% and 85.98{plus minus}13.42% in control group and study group respectively (p=0.29). Average rate of healing achieved at 6 weeks was 0.64{plus minus}0.36cm2 and 0.71{plus minus}0.46cm2 in control group and study group respectively (p=0.734). CONCLUSIONS PRP dressing is no more efficacious than normal saline dressing in management of DFU in conjunction with total contact casting.
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6.
Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial
Neogi SB, Devasenapathy N, Singh R, Bhushan H, Shah D, Divakar H, Zodpey S, Malik S, Nanda S, Mittal P, et al
The Lancet. Global health. 2019;7(12):e1706-e1716
Abstract
BACKGROUND Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. METHODS We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1.14% under the null effects, 3.0% under the continued effects, and 44.83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. FINDINGS Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0.95, 95% CI 0.70-1.29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. INTERPRETATION The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. FUNDING WHO, India.
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7.
The effects of autologous platelet concentrate on the healing of intra-bony defects: a randomized clinical trial
Kudyar N, Dani N, Abullais SS, AlQahtani NA, Gupta A, Attar N
European oral research. 2019;53(1):38-43
Abstract
Purpose: The present study aimed to evaluate the clinical and radiographic effects of autologous platelet concentrate (APC) on the healing of intra-bony defects filled with beta-tricalcium phosphate (beta-TCP) and covered with collagen membranes. Subjects and methods: This study included 30 defects of 14 systemically healthy subjects. All of them had, at least, two deep intra-bony, inter-proximal periodontal defects. Minimum probing pocket depth (PPD) was 6 mm. Clinical and imaging examination was performed both at baseline and at 3, 6, and 9 months after surgery. Results: Both the test and control group revealed a significant reduction in all variables when compared with the base line. Mean reduction of the PPD in two groups at each follow-up time point showed no significant difference. Means of the clinical attachment gain of the same groups were significantly different (p<0.05). Mean gingival recession at 3 month was not significant. However, the means of gingival recession coverage of two groups were significantly different at 6 and 9 months (p<0.05 for both). Conclusion: Sites treated with APC are more likely to demonstrate more clinical attachment gain and recession coverage at the end of 9 month compared to those without APC.
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8.
Randomized trial to assess safety and clinical efficacy of intensive blood pressure reduction in acute spontaneous intracerebral haemorrhage
Gupta S, Abbot A K, Srinath R, Tewari A K, Gupta A, Gorthi S P, Narayanan C S, Totlani S I, Sirohi Y S, Anadure R
Medical Journal, Armed Forces India. 2018;74((2)):120-125.
Abstract
Background: Haematoma expansion due to raised blood pressure in spontaneous intracerebral haemorrhage may determine outcome. The aim of this study was to determine safety and efficacy of lowering blood pressure in acute spontaneous intracerebral haemorrhage. Methods: This open label, multicentric trial randomized patients ≥18 years with spontaneous intracerebral haemorrhage with no secondary cause within 72 h of onset to tight BP control arm where treatment was initiated if mean arterial pressure (MAP) was ≥115 mm of Hg and conventional BP control arm where treatment was initiated if MAP was ≥130 mm of Hg. The MAP was maintained in the respective arm for another 72 h after which both arms had MAP below 115 mm of Hg. Primary outcome was modified Rankin Scale at 90 days. Results: 118 patients, 59 in each arm were included. Follow up was available for all. Baseline characteristics were similar. At 90 days there was no significant difference between median mRS between the two arms. Odds Ratio for "poor outcome" (mRS 3-6) in the tight control arm (safety of the intervention) against "good outcome" (mRS 0-2) was not significant (OR 0.70 [95% CI 0.34-1.47] p = 0.35). Efficacy of the intervention in the form of Odds Ratio for "good outcome" in the tight control arm was not significant (OR 1.43 [95% CI 0.68-2.99], p = 0.35). Conclusion: In patients with spontaneous intracerebral haemorrhage who present within 72 h of the onset of symptoms, MAP can be safely lowered if it crosses 115 mm of Hg but it does not improve clinical outcome.
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9.
Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients
Gupta A, Lin V, Guss C, Pratt R, Ikizler TA, Besarab A
Kidney International. 2015;88((5)):1187-94.
Abstract
Ferric pyrophosphate citrate (FPC) is a water-soluble iron salt administered via dialysate to supply iron directly to transferrin. The PRIME study tested whether treatment with FPC could reduce prescribed erythropoiesis-stimulating agent (ESA) use and maintain hemoglobin in hemodialysis patients. This 9-month, randomized, placebo-controlled, double-blind, multicenter clinical study included 103 patients undergoing hemodialysis 3-4 times weekly. The FPC group received dialysate containing 2mumol/l of iron. The placebo group received standard dialysate. A blinded central anemia management group facilitated ESA dose adjustments. Intravenous iron was administered according to the approved indication when ferritin levels fell below 200mug/l. The primary end point was the percentage change from baseline in prescribed ESA dose at end of treatment. Secondary end points included intravenous iron use and safety. At the end of treatment, there was a significant 35% reduction in prescribed ESA dose in FPC-treated patients compared with placebo. The FPC patients used 51% less intravenous iron than placebo. Adverse and serious adverse events were similar in both groups. Thus, FPC delivered via dialysate significantly reduces the prescribed ESA dose and the amount of intravenous iron needed to maintain hemoglobin in chronic hemodialysis patients.
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10.
A randomised controlled trial to compare intravenous iron sucrose and oral iron in treatment of iron deficiency anemia in pregnancy
Gupta A, Manaktala U, Rathore AM
Indian Journal of Hematology & Blood Transfusion. 2014;30((2):):120-5.
Abstract
The aim of this study was to compare the efficacy and safety of intravenous iron sucrose with oral iron therapy in pregnant patients with anemia. The primary outcome of the study was increase in haemoglobin on day 7, 14 & 28 and rise of serum ferritin over 28 days. The study population consisted of 100 patients with singleton pregnancy between 24 and 34 weeks, hemoglobin levels between 7.0-9.0 gm/dL and serum ferritin levels less than 15 ng/mL. The participants in the oral group were given daily 180 mg elemental iron in three divided oral doses for 4 weeks. Total calculated dose of iron sucrose with a target hemoglobin of 11 gm %, was given in 200 mg dose on alternate days. Mean haemoglobin rise was 0.58 gm/dL in the IV group as compared to 0.23 gm/dL in the oral group on day 14 and 1.9 gm/dL in the IV group & 1.3 gm/dL in the oral group on day 28, (p <0.05). In the IV group, 76% of the subjects achieved haemoglobin levels of >11 gm% at the time of delivery, as compared to only 54% of the subjects in the oral group who achieved these levels. Serum ferritin value was significantly higher in the IV group, 37.45 + 5.73 ng/mL as compared to 13.96 + 1.88 ng/mL in the oral group at 4th week (p <0.001). There was no major side effect in the IV group. 36% subjects in the oral group developed gastrointestinal side effects & 10% of the subjects were non compliant. The rate of hemoglobin rise is faster with intravenous iron sucrose therapy as compared to oral iron therapy which can be beneficial in pregnant women presenting with anemia at a later period of gestation. Intravenous iron sucrose is very well tolerated during pregnancy.