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1601. Effectiveness of different treatment regimens for peri-implantitis

complex and expensive therapies for peri-implantitis Candice G. McMullan-Vogel DDS . Overview Systematic Review Conclusion Local antibiotics, bone augmentation and subgingival débridement all may be effective in treating peri-implantitis. Critical Summary Assessment There is a need for properly designed studies to identify which treatments are most effective for peri-implantitis. Evidence Quality Rating Limited Evidence This summary is published in the Journal of the American Dental Association

2010 ADA Center for Evidence-Based Dentistry

1602. Patients may not need to stop oral anticoagulant therapy for simple oral surgical procedures

focused on clinically relevant outcomes of the studies, principally differences in postoperative bleeding rates and the control of any bleeding that did occur. Although the title implies that the dealt with the influence of OAT on oral implant therapy, all data provided relate only to simple oral surgical procedures. The authors recommended that drugs that may increase bleeding tendencies, aspirin and other NSAIDs, and antibiotics that can potentiate the anticoagulant effect of OAT be avoided prior

2010 ADA Center for Evidence-Based Dentistry

1603. Some evidence shows that certain mouthrinses can reduce halitosis

Kumar DDS, MDSc . Overview Systematic Review Conclusion Mouthrinses containing antibacterial agents (chlorhexidine and cetylpyridinium chloride) or those containing chlorine dioxide and zinc can reduce halitosis to some extent. Critical Summary Assessment Although antibacterial mouthrinses can reduce halitosis, the extent of effectiveness is uncertain owing to incomplete reporting, possible study and variation in patients’ characteristics and assessment methods. Evidence Quality Rating Limited

2010 ADA Center for Evidence-Based Dentistry

1604. Helping former smokers stay on the wagon: insufficient evidence regarding relapse prevention interventions for smoking cessation

are the strongest resources to aid dental professionals in clinical decision making and help incorporate evidence gained through scientific investigation into patient care. Guidelines include recommendation statements intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. Antibiotics for Dental Pain and Swelling Guideline A panel of experts convened by the ADA Council on Scientific Affairs presents clinical (...) recommendations concerning the use of antibiotics for the urgent management of pulpal- and periapical-related dental pain and intra-oral swelling. This guideline updates the 1997 recommendations by the American Heart Association for the prevention of infective endocarditis (IE). The committee concluded that IE prophylaxis for dental procedures should be recommended only for patients with underlying cardiac conditions associated with the highest risk of adverse outcomes from IE. A panel of experts convened

2010 ADA Center for Evidence-Based Dentistry

1605. Glycemic control of diabetics may improve slightly with periodontal treatment

levels. Main Results: The review included three RCTs and two CCTs, both of which totaled 199 treated patients and 183 control patients. All patients had type 2 diabetes and periodontitis. Periodontal treatment was scaling and root planning, with or without antibiotic therapy. All studies reported absolute change in A1C. A1C levels of 8 percent and less are considered good and 10 percent and above are considered poor. All studies showed an improved (decreased) A1C level in treated patients ranging (...) a lack of precision in the estimate of effect. The lacked robustness due to significant among the studies. The CCTs introduced by placing treatment avoiders in the control groups. Baseline A1C levels generally reflected poor glycemic control. However, some subjects in two of the RCTs had good control, which may have affected their treatment results. The studies used different or unstated definitions of periodontitis. When antibiotics were used, the protocols changed. Only two studies reported

2010 ADA Center for Evidence-Based Dentistry

1606. Limited evidence suggests no difference in denture cleaning methods

information. The inclusion criteria were limited to randomized clinical trials (RCTs) comparing any mechanical method or chemical in adults over age 18 wearing removable partial or complete dentures. Studies were excluded if participants had implant-retained prostheses or a history of corticosteroid or antimicrobial use within 3 months. Primary outcomes considered included health of denture bearing areas and patient satisfaction and preference. Secondary outcomes included denture plaque coverage area

2010 ADA Center for Evidence-Based Dentistry

1607. Effectiveness of different treatment regimens for peri-implantitis

complex and expensive therapies for peri-implantitis Candice G. McMullan-Vogel DDS . Overview Systematic Review Conclusion Local antibiotics, bone augmentation and subgingival débridement all may be effective in treating peri-implantitis. Critical Summary Assessment There is a need for properly designed studies to identify which treatments are most effective for peri-implantitis. Evidence Quality Rating Limited Evidence This summary is published in the Journal of the American Dental Association

2010 ADA Center for Evidence-Based Dentistry

1608. Glycemic control of diabetics may improve slightly with periodontal treatment

levels. Main Results: The review included three RCTs and two CCTs, both of which totaled 199 treated patients and 183 control patients. All patients had type 2 diabetes and periodontitis. Periodontal treatment was scaling and root planning, with or without antibiotic therapy. All studies reported absolute change in A1C. A1C levels of 8 percent and less are considered good and 10 percent and above are considered poor. All studies showed an improved (decreased) A1C level in treated patients ranging (...) a lack of precision in the estimate of effect. The lacked robustness due to significant among the studies. The CCTs introduced by placing treatment avoiders in the control groups. Baseline A1C levels generally reflected poor glycemic control. However, some subjects in two of the RCTs had good control, which may have affected their treatment results. The studies used different or unstated definitions of periodontitis. When antibiotics were used, the protocols changed. Only two studies reported

2010 ADA Center for Evidence-Based Dentistry

1609. Limited evidence suggests no difference in denture cleaning methods

information. The inclusion criteria were limited to randomized clinical trials (RCTs) comparing any mechanical method or chemical in adults over age 18 wearing removable partial or complete dentures. Studies were excluded if participants had implant-retained prostheses or a history of corticosteroid or antimicrobial use within 3 months. Primary outcomes considered included health of denture bearing areas and patient satisfaction and preference. Secondary outcomes included denture plaque coverage area

2010 ADA Center for Evidence-Based Dentistry

1610. Cefepime for Injection USP and Dextrose Injection USP in the Duplex® Container

prescribing decisions based upon the meta analysis? Taken without critical examination, the meta analysis published by Yahav and colleagues seems to implicate cefepime as the cause of higher mortality compared with that among patients treated with other beta lactam antibiotics. In an era with limited development of new antimicrobials for resistant Gram-negative organisms, agents like cefepime have a very important role. Losing cefepime as a major antimicrobial for the treatment and prophylaxis (...) in Pseudomonas aeruginosa: About 24 cases at Rouen University Hospital.] Pathol Biol (Paris). 2008 Nov-Dec;56(7-8):429-34. Epub 2008 Oct 4. French. 15. Matyar F, Kaya A, Dinçer S. Antibacterial agents and heavy metal resistance in Gram negative bacteria isolated from seawater, shrimp and sediment in Iskenderun Bay,Turkey.Sci Total Environ. 2008 Dec 15;407(1):279-85. Epub 2008 Sep 19. 16. Sauermann R, Schwameis R, Fille M, Ligios ML, Zeitlinger M. Antimicrobial activity of cefepime and rifampicin

2009 FDA - Drug Approval Package

1611. Rilutek - riluzole

attributes. In this case series, drug-related attributes included a strong temporal drug relationship and a correlation between inadequate responses to an antibiotic challenge and in turn a favorable response to riluzole 3 withdrawal and steroid pulse therapy. Based on this correlation of events, 14 healthcare professionals reported and assessed the drug-event relationship as probable or likely. In our case series, two cases reported a constellation of adverse events including features of or a diagnosis (...) . d Death was due to the progression of ALS A representative case of ILD with riluzole follows: ISR#4454417/MFR#200413969JP/2005 A 62 year old male patient had been on riluzole 100 mg daily for the treatment of amyotrophic lateral sclerosis (ALS) since 20Oct03. On 10Nov03, cough and pyrexia developed. The symptoms didn’t improve with antibiotics and dyspnea developed. The patient was hospitalized on 18Nov03

2009 FDA - Drug Approval Package

1612. Kombiglyze XR (saxagliptin/metformin extended release) fixed dose combination tablets

diamide hydrochloride) is a biguanide. Metformin hydrochloride is a white crystalline with a molecular formula of C4H11N5•HCl. Figure 2 The structural formula of metformin metformin hydrochloride (b) (4) (b) (4)Clinical Review Arlet V. Nedeltcheva, M.D. NDA 200678 saxagliptin/metformin XR FDC 13 See the CMC review for a discussion of the characteristics of the FDC tablet. 4.2 Clinical Microbiology Not applicable- saxagliptin is not an antimicrobial. 4.3 Preclinical Pharmacology/Toxicology The sponsor

2009 FDA - Drug Approval Package

1613. Exenatide (Byetta) subcutaneous injection

is not an antimicrobial agent. 6.1.6 Efficacy Conclusions • The primary objective was to determine if glycemic control as measured by the change in HbA1c from baseline to endpoint with exenatide twice daily (BID) was superior to placebo BID after 24 wks treatment in patients with T2D who had inadequate control with diet and exercise. Only the exenatide groups experienced a statistically significant improvement in HbA1c compared to baseline. The LS mean treatment difference (exenatide – placebo) at endpoint was -0.5

2009 FDA - Drug Approval Package

1615. Rifadin infusion (rifampicin): new solvent formulation and changes to compatible diluents

chloride 0·9% solution Published 11 December 2014 From: Therapeutic area: Article date: April 2010 Rifadin 600 mg infusion (rifampicin) is used to treat various infections, including tuberculosis and leprosy. It is indicated for acutely ill patients who are unable to tolerate oral therapy. To prevent emergence of resistant strains, Rifadin should be used in combination with another appropriate antibiotic. New solvent formulation The solvent used in the preparation of Rifadin infusion has been

2010 MHRA Drug Safety Update

1616. Isotretinoin: risk of serious skin reactions

Isotretinoin (brand leader Roaccutane) is a treatment for severe acne that is resistant to adequate courses of standard antibacterial or topical therapy. Over the past 25 years in which isotretinoin has been on the market, it has been prescribed worldwide for approximately 16 million patients. Association with serious skin reactions The licence holder for Roaccutane identified a possible association between isotretinoin use and serious skin conditions including erythema multiforme (EM), Stevens Johnson

2010 MHRA Drug Safety Update

1617. Carbapenems: concomitant use with valproic acid not recommended

professionals should consider alternative antibacterial therapy Published 11 December 2014 From: Therapeutic area: , Article date: May 2010 Carbapenems are a class of beta-lactam antibiotics with broad-spectrum antibacterial activity. They are indicated for the treatment of the following infections when caused by susceptible bacteria: nosocomial pneumonia complicated intra-abdominal infections complicated urinary tract infections Valproic acid/sodium valproate is an anticonvulsant used for the treatment (...) that decreased valproic acid levels have also been reported when co-administered with other carbapenems, with 60–100% decreases in valproic acid levels being observed within about 2 days. This interaction is therefore likely to be a class effect. Concomitant use of carbapenems and valproic acid/sodium valproate is not recommended, and prescribers should consider alternative antibacterial therapy. Advice for healthcare professionals: a clinically significant interaction between carbapenems and valproic acid

2010 MHRA Drug Safety Update

1618. Randomised controlled trial: Preoperative skin cleansing with chlorhexidine-alcohol reduces surgical site infection after clean-contaminated surgery compared with povidone-iodine

procedures are performed each year in the USA. 1 Despite the implementation of a bundle of preventive measures such as preoperative use of hair clippers or no hair removal (as opposed to shaving), initial administration of perioperative antibiotics within 1 hour before surgery, and maintenance of normothermia, normoglycaemia and hyperoxia during surgery and for the first 2 hours after surgery, between 300 000 and 500 000 patients develop a surgical site infection (SSI). These infections increase length

2010 Evidence-Based Nursing

1619. Manuka honey improved wound healing in patients with sloughy venous leg ulcers

: randomised controlled trial. Allocation: concealed.* Blinding: blinded (statistician).* Study question Setting: vascular centres, leg ulcer clinics, and acute and community care hospitals. Patients: 108 patients >18 years of age (mean age 68 y) who had a venous leg ulcer (VLU) <100 cm 2 with ⩾50% of the wound bed covered in slough. Exclusion criteria were malignant ulcer, wound infection, presence of a cavity wound, use of antibiotics or oral immunosuppressants, poorly controlled diabetes, pregnancy

2009 Evidence-Based Medicine

1620. 1 day of nitrofurantoin was not as effective as 7 days for asymptomatic bacteriuria in pregnancy

bacteriuria caused by a micro-organism sensitive to nitrofurantoin. Women with symptoms of urinary tract infection (UTI), treatment of UTI in the current pregnancy, a condition requiring continuous steroid or antibiotic therapy, antibiotic hypersensitivity, or haematological disease (including glucose-6-phosphate dehydrogenase deficiency) were excluded. Intervention: nitrofurantoin, 100 mg orally twice daily, for 1 day (n = 386) or 7 days (n = 392). The 1-day group received placebo tablets after day 1

2009 Evidence-Based Medicine

Evidence-based Synopses

Synopses are typically easily digested, critical commentaries of articles e.g. critically appraised topics.