Tranexamic acid and bleeding in patients treated with non-vitamin K oral anticoagulants undergoing dental extraction: The EXTRACT-NOAC randomized clinical trial
PLoS medicine. 2021;18(5):e1003601
BACKGROUND Oral bleeding after dental extraction in patients on non-vitamin K oral anticoagulants (NOACs) is a frequent problem. We investigated whether 10% tranexamic acid (TXA) mouthwash decreases post-extraction bleeding in patients treated with NOACs. METHODS AND FINDINGS The EXTRACT-NOAC study is a randomized, double-blind, placebo-controlled, multicenter, clinical trial. Patients were randomly assigned to 10% TXA or placebo mouthwash and were instructed to use the mouthwash prior to dental extraction, for 3 times a day for 3 days thereafter. The primary outcome was the number of patients with any post-extraction oral bleeding up to day 7. Secondary outcomes included the periprocedural, early, and delayed bleeding, and the safety outcomes included all thrombotic events. The first patient was randomized on February 9, 2018 and the last patient on March 12, 2020. Of 222 randomized patients, 218 patients were included in the full analysis set, of which 106 patients were assigned to TXA (74.8 (±8.8) years; 81 men) and 112 to placebo (72.7 (±10.7) years; 64 men). Post-extraction bleeding occurred in 28 (26.4%) patients in the TXA group and in 32 (28.6%) patients in the placebo group (relative risk, 0.92; 95% confidence interval [CI], 0.60 to 1.42; P = 0.72). There were 46 bleeds in the TXA group and 85 bleeds in the placebo group (rate ratio, 0.57; 95% CI, 0.31 to 1.05; P = 0.07). TXA did not reduce the rate of periprocedural bleeding (bleeding score 4 ± 1.78 versus 4 ± 1.82, P = 0.80) and early bleeding (rate ratio, 0.76; 95% CI, 0.42 to 1.37). Delayed bleeding (rate ratio, 0.32; 95% CI, 0.12 to 0.89) and bleeding after multiple extractions (rate ratio, 0.40; 95% CI, 0.20 to 0.78) were lower in the TXA group. One patient in the placebo group had a transient ischemic attack while interrupting the NOAC therapy in preparation for the dental extraction. Two of the study limitations were the premature interruption of the trial following a futility analysis and the assessment of the patients' compliance that was based on self-reported information during follow-up. CONCLUSIONS In patients on NOACs undergoing dental extraction, TXA does not seem to reduce the rate of periprocedural or early postoperative oral bleeding compared to placebo. TXA appears to reduce delayed bleeds and postoperative oral bleeding if multiple teeth are extracted. TRIAL REGISTRATION ClinicalTrials.gov NCT03413891 EudraCT; EudraCT number:2017-001426-17; EudraCT Public website: eudract.ema.europa.eu.
Clinical and radiographic evaluation of demineralized freeze-dried bone allograft with concentrated growth factor versus concentrated growth factor alone in the treatment of intrabony defects
Medicine and pharmacy reports. 2021;94(2):220-228
BACKGROUND Periodontal disease is one of the major causes of alveolar bone loss. There are various ways of regenerating the lost bone, i.e. guided tissue regeneration, bone grafts, and growth factors. In this purview, it becomes immensely important for a clinician to decide the best modality of treatment. In this study, we compared the effect of demineralized freeze-dried bone allograft (DFDBA) in combination with concentrated growth factors (CGF) verses CGF alone. METHODS This double-blind, split-mouth study was conducted on ten patients with two comparable bilateral intrabony defects. Each pair of defects was randomly treated by DFDBA + CGF or CGF alone. Clinical parameters such as plaque index (PI), modified gingival index (MGI), pocket probing depth (PPD), and relative attachment level (RAL) were recorded at baseline, three months, and six months. In addition, radiograph with grids was also taken at baseline and six months. The paired t-test was used to compare the pre- and post-treatment values and the unpaired t-test was used to compare the test and control group. RESULTS The PI score decreased significantly from baseline to six months. Similarly, the mean MGI score decreased significantly from baseline to six months. The intragroup comparison showed that there was a significant reduction in PPD in both the test and control group. However, the intergroup comparison showed that the reduced pocket depth was not significant. The intragroup radiographic comparison showed that there was the significant formation of bone in both the test and control group but inter-group showed that the formation of bone among both the group were non-significant. CONCLUSION Radiographic and clinical outcomes of this study concluded that post six months, both groups demonstrated significant improvement in clinical and radiographic parameters. However, the addition of DFDBA to CGFs did not give any additional benefits.
Complications and Management of Patients with Inherited Bleeding Disorders During Dental Extractions: a Systematic Literature Review
Journal of oral & maxillofacial research. 2021;12(2):e1
OBJECTIVES The systematic literature review aims to assess patients' dental extraction with inherited bleeding disorders, to understand the type, dosage, and modality of administration of the haemostatic agents for safe intra- and postoperational results. MATERIAL AND METHODS The search was undertaken in MEDLINE (PubMed) databases and Cochrane library for articles published in English from 1 January, 2010 till 31 October, 2020. Before the full-text articles were considered, titles and abstracts were screened. RESULTS A total of 78 articles were screened, from which 3 met the necessary criteria and were used for the review. Minor complications, such as postoperative bleedings from the socket and epistaxis, were observed, but they were resolved with proper medical care. No major fatal complications were reported. Generally, all the articles provided evidence of successful extractions with correct treatment plans made by haematologists and surgeons. CONCLUSIONS Available clinical trials demonstrate that local and systemic haemostatic therapies in combination are effective in preventing bleeding during dental extractions in patients with coagulopathies.
Effect of hydroxyethyl cellulose soluble hemostatic gauze on hemostasis in facial contouring surgery
BACKGROUND In facial contour surgery, due to the narrow field of vision in the oral approach and the abundant blood supply to the maxillofacial area, hemostasis is not easy. The purpose of this study was to evaluate the hemostatic effect of soluble hemostatic gauze. METHODS We organized a prospective randomized study of 282 patients receiving facial contouring surgery (4 types of procedures in total) during 2016.1.1 to 2018.12.30. For each type of procedure, patients were randomly divided into study group (received hemostatic gauze) and control group (received sterile gauze). Two groups were compared for each type of procedure regarding 5 major perioperative variables: intraoperative blood loss, operation time, 24-hour postoperative drainage volume, total postoperative drainage volume, and postoperative drainage time. Correlation between variables was analyzed. RESULTS Compared with control group, the study group had higher amount of intraoperative blood loss in mandibular angle ostectomy (MAO) (P < .01) and mandibular angle-body-chin curved ostectomy procedures (P < .05), less total postoperative drainage volume in MAO (P < .01) but not in malarplasty with MAO and partial masseter muscle resection along with MAO procedures. No significant difference was observed between respective study and control groups regarding operation time, 24-hour postoperative drainage volume, and postoperative drainage time in any of the 4 types of surgery. In all 4 types of procedures, a strongly positive correlation was observed between total drainage volume and 24-hour drainage volume in both the study and control groups (r: 0.88-0.97, P < .01). CONCLUSION The effect of hydroxyethyl cellulose soluble hemostatic gauze on hemostasis in facial contouring surgery is associated with the type of surgery, which can reduce the risk of postoperative bleeding in MAO. However, for surgery with relatively large amount of intraoperative and postoperative bleeding, the hemostatic gauze had a limited postoperative hemostasis efficacy, which needs further evaluation.
Intraoperative Blood Loss and Postoperative Pain in the Sagittal Split Ramus Osteotomy and Intraoral Vertical Ramus Osteotomy: A Literature Review
BioMed research international. 2021;2021:4439867
PURPOSE The purpose of the present study was to review the literature regarding the blood loss and postoperative pain in the isolated sagittal split ramus osteotomy (SSRO) and intraoral vertical ramus osteotomy (IVRO). MATERIALS AND METHODS Investigating the intraoperative blood loss and postoperative pain, articles were selected from 1970 to 2021 in the English published databases (PubMed, Web of Science, and Cochrane Library). Article retrieval and selection were performed by two authors, and they independently evaluated them based on the eligibility criteria. The articles meeting the search criteria had especially at least 30 patients. RESULTS In the review of intraoperative blood loss, a total of 139 articles were retrieved and restricted to 6 articles (SSRO: 4; IVRO 2). In the review of postoperative pain, a total of 174 articles were retrieved and restricted to 4 articles (SSRO: 3; IVRO 1). The mean blood loss of SSRO and IVRO was ranged from 55 to 167 mL and 82 to 104 mL, respectively. The mean visual analog scale (VAS) scores of the first postoperative day were 2 to 5.3 in SSRO and 2.93 to 3.13 in IVRO. The mean VAS scores of the second postoperative day were 1 to 3 in SSRO and 1.1 to 1.8 in IVRO. CONCLUSION Compared to traditional SSRO, IVRO had a significantly lower amount of blood loss. However, the blood transfusion is not necessary in a single-jaw operation (SSRO or IVRO). Postoperative pain was similar between SSRO and IVRO.
Efficacy and Safety of Tranexamic Acid in Bimaxillary Orthognathic Surgery
Plast Surg (Oakv). 2020;28(2):94-104
Background: Tranexamic acid (TXA) has been widely used during craniofacial and orthognathic surgery (OS). However, results of the literature are inconsistent due to specific type of surgery and a small sample of studies. The purpose of this study was to evaluate the role of TXA in bimaxillary OS. Methods: We performed a comprehensive literature search of PubMed, Cochrane Central Register of Controlled Trials, and EMBASE to identify randomized controlled trials (RCTs) that compared effect of TXA on bimaxillary OS with placebo. Outcomes of interests included intraoperative blood loss, allogenic transfusion, operation time, and volume of irrigation fluid. Random effects models were chosen considering that heterogeneity between studies was anticipated, and I (2) statistics were used to test for the presence of heterogeneity. Results: Totally 6 RCTs were identified. Tranexamic acid resulted in significantly reduced intraoperative blood loss (weighted mean difference [WMD] = -264.82 mL; 95% CI: -380.60 to -149.04 mL) and decreased amounts of irrigation fluid (WMD = -229.23 mL; 95% CI: -399.63 to -58.83 mL). However, TXA had no remarkable impact on risk of allogenic blood transfusion (pooled risk ratio = 0.50; 95% CI: 0.20-1.23), operation time (WMD = -8.71 min; 95% CI: -20.98 to 3.57 min), and length of hospital stay (WMD = -0.24 day; 95% CI: -0.62 to 0.14 day). No TXA-associated severe adverse reactions or complications were observed. Conclusions: Currently available meta-analysis reveals that TXA is effective in decreasing intraoperative blood loss; however, it does not reduce the risk of allogenic blood transfusion in bimaxillary OS.
Hemostatic agents in endodontic surgery of maxillary molars: A randomized controlled pilot study of polytetrafluoroethylene (PTFE) strips as an adjunct to epinephrine impregnated gauze versus aluminum chloride
Med Oral Patol Oral Cir Bucal. 2020
BACKGROUND Hemostasis is of critical importance in endodontic surgery. Studies on bleeding control in maxillary molars are scarce. The present study compares the efficacy of two hemostatic techniques in controlling bleeding in endodontic surgery. MATERIAL AND METHODS A randomized two-arm pilot study involving 30 patients with peri-radicular lesions in maxillary molars (first and second molars) was carried out including the following hemostatic agents: polytetrafluoroethylene (PTFE) strips as an adjunct to epinephrine impregnated gauze (test group; n = 15) and aluminum chloride (Expasyl™) (control; n = 15). Bleeding control was independently assessed by the surgeon and by two blinded observers before and after application of the hemostatic agent, and was classified as either adequate (complete bleeding control) or inadequate (incomplete bleeding control). RESULTS Bleeding control was similar in both groups. Simple binary logistic regression analysis failed to identify variables affecting bleeding control. Only the height of the keratinized mucosal band (≥ 2 mm) suggested a decreased risk of inadequate bleeding control of up to 89% (OR=0.11; p=0.06). CONCLUSIONS No difference in the efficacy of bleeding control was observed between PTFE strips as an adjunct to epinephrine impregnated gauze and aluminum chloride in maxillary molars.
Tranexamic Acid in Aesthetic Facial Plastic Surgery: A Systematic Review of Evidence, Applications, and Outcomes
Aesthetic surgery journal. Open forum. 2020;2(3):ojaa029
BACKGROUND Tranexamic acid (TXA) is an antifibrinolytic that has become widely used in aesthetic facial plastic surgery, although its efficacy has not been well investigated. OBJECTIVES To evaluate the existing evidence for use of TXA in aesthetic facial plastic surgery, highlighting routes of administration, dosing, surgical applications, and clinical outcomes. METHODS Systematic review of primary literature evaluating TXA in aesthetic facial plastic surgery. RESULTS Eleven studies met inclusion criteria: 8 prospective randomized controlled trials, 2 retrospective case series/cohort studies, and 1 clinical opinion. Six studies evaluated TXA in rhinoplasty, 4 in rhytidectomy, and 1 in blepharoplasty. Significant reductions in intraoperative blood loss were found in 5 rhinoplasty studies. Three rhinoplasty and 2 rhytidectomy studies found significantly reduced postoperative edema and ecchymosis. One rhinoplasty and 1 rhytidectomy study reported reduced operative time and time to achieve hemostasis. One rhytidectomy study reported reduced postoperative drain output and faster time to drain removal. No studies reported an adverse outcome directly related to TXA. CONCLUSIONS Existing literature investigating TXA in aesthetic facial plastic surgery is sparse with varying levels of evidence and heterogeneous data. Literature suggests systemic TXA reduces intraoperative blood loss during rhinoplasty, although the clinical significance of this blood loss reduction is unclear. TXA may also reduce postoperative edema and/or ecchymosis in rhytidectomy and rhinoplasty, although the lack of validated grading scales yields insufficient evidence to support this claim. Topical and subcutaneously injected TXA are emerging administration routes in rhytidectomy, with evidence suggesting TXA mixed with tumescent may reduce postoperative drain output, thereby expediting drain removal.
Randomized Clinical Trial Comparing Three Local Hemostatic Agents for Dental Extractions in Patients under Chronic Anticoagulant Therapy - A Comparative Study
Annals of maxillofacial surgery. 2020;10(2):292-296
INTRODUCTION Oral anticoagulants are widely used worldwide for many systemic diseases. Recent oral surgical protocols suggest that therapeutic levels of the anticoagulant drug should be maintained for simple dental extractions because bleeding complications could be managed with proper local hemostasis. The aim of the present study was to compare bleeding complication of three different local hemostatic agents for dental extractions without interrupting drug administration in patients undergoing oral Vitamin K antagonist chronic anticoagulant therapy. MATERIAL AND METHODS Randomized control trial of three hemostatic agents for dental extractions, in patients under oral anticoagulant therapy without drug interruption. The present study included 240 patients with international normalized ratio between 1.5 and 3.5. Patients took their anticoagulation drug normally. A single surgeon performed calibrated simple dental extractions and applied a plug of bismuth subgallate (BS), fibrin tissue adhesive (FTA) or microfibrillar collagen (MC), assigned randomly. Statistical analysis of bleeding between the groups was performed using the Chi-square test. RESULTS There was no hemorrhagic complication in the BS group, and only one in the FTA group. However, in the MC group, 10 patients (12.5%) suffered postoperative bleeding. Data analysis showed statistical differences between the MC group and the other two groups (P < 0.05). DISCUSSION BS and FTA showed similar clinical effectiveness and were more effective than MC for the control of postoperative bleeding in oral anticoagulated patients.
A Comparative Evaluation of the Effectiveness of Chitosan-Based Dressing and Conventional Method of Hemostasis in Patients on Oral Antithrombotic Therapy without Therapy Interruption
Journal of pharmacy and bioallied sciences.. 2019;11(Suppl 1):S18-S23
Aims and Objectives: To assess the effectiveness of chitosan-based dressing after extraction in individuals on antithrombotics, without modification of their treatment schedule. Materials and Methods: A randomized comparative study was carried out on 40 subjects who had two extraction sites, in dissimilar quadrants. The surgical site was chosen at random and post-extraction hemostasis was achieved by a custom-cut chitosan dressing (study site) and sterile cotton gauze dressing (suturing if required) at control site. Patients were reviewed on the first, third, fifth, and seventh postoperative days and every week till 4 weeks. The parameters assessed were timing of hemostasis, pain scores, and pus discharge. Results: Out of 40 study subjects, 24 (60%) were males and 16 (40%) were females. The age was 40-65 years (mean age 54 years). The mean time for hemostasis was 0.63 +/- 0.27 min in study group, whereas for controls, it was 9.10 +/- 2.28 min. The difference in postoperative pain was significant (P = 0.001) on days one, five, and seven. In chitosan group extraction sites, dry socket was not seen, whereas four patients on day three and five patients on day five after extraction experienced dry socket in pressure gauze dressings group, with an insignificant difference (P = 0.058). In chitosan group extraction sites, no pus discharge was seen. Whereas four patients on days three and five after extraction had pus discharge in patients where pressure dressings were applied, with an insignificant difference (P = 0.058). Conclusion: Chitosan dressing is a competent hemostatic agent that significantly reduced the post-extraction bleeding, with better pain control. Chitosan group had no incidences of dry socket and pus discharge.