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Products Inc. (products + inc)

Distribution by Scientific Domains

Medical Sciences	75%

Selected Abstracts

Desensitizing Agent Efficacy during Whitening in an At-Risk Population

JOURNAL OF ESTHETIC AND RESTORATIVE DENTISTRY, Issue 1 2004
RALPH H. LEONARD Jr. DDS.
ABSTRACT Background: Nightguard vital bleaching (NGVB) has gained acceptance among dentists and patients as a simple and effective procedure to lighten discolored teeth. Although the efficacy and predictability of NGVB have been well established, it has been documented that patients undergoing the procedure may experience side effects such as tooth sensitivity (TS) and gingival irritation (GI). A previous NGVB study suggested that selected participants might benefit from a regimen of a desensitizing agent (DSA)to decrease or prevent TS during whitening. Purpose: The purpose of this study was to determine whether the daily use of an active DSA (UltraEZTM, Ultradent Products Inc., South Jordan, UT, USA) during NGVB would decrease TS in a population at risk for TS when compared with a placebo. Materials and Methods: Forty subjects participated in this single-blind randomized clinical trial. All participants had indicated that they had preexisting TS or other risk factors for TS during NGVB. To evaluate TS caused by the tray alone, participants wore custom-fitted maxillary whitening trays containing no DSA or whitening solution during week 1. Next, participants were randomly assigned to apply either the active DSA or placebo daily for 14 days in the trays for 30 minutes prior to whitening. The placebo was the same formulation as UltraEZ but without the desensitizing agents (3% potassium nitrate and 0.11% by weight fluoride ion). The bleaching solution was a 10% carbamide peroxide whitening solution (OpalescenceTM, Ultradent Inc.). Post treatment, participants were followed up for 1 week, during which time they used neither trays nor solutions. Throughout the study, participants completed a daily diary to record their perceptions of TS and the time spent wearing the tray with the whitening solution. Results: Forty-one percent of the active group had at least 1 day of TS during treatment compared with 78% of the placebo group. The difference was statistically significant (p= .027) using the two-tailed Fisher exact test. [source]

Utah Medical Products Inc. and the FDA: Regulatory Dogma versus Flexible Interpretation

QUALITY ASSURANCE JOURNAL, Issue 2 2006
C. Burgess
Abstract This paper reviews the regulatory compliance background and the 2005 court case between the Food and Drug Administration (FDA) and Utah Medical Products Incorporated which supported the company's and not the Agency's interpretation of 21 Code of Federal Regulations (CFR) Part 820, the Quality System Regulations (QSR). This is the first time that the Agency has lost such a court case; the key issues in the case are presented and discussed. The judgement also shows the value of re-reading the regulations to interpret what is actually required rather than custom and practice. Copyright © 2006 John Wiley & Sons, Ltd. [source]

ORIGINAL ARTICLE: Safety Analysis of the Diaphragm in Combination with Lubricant or Acidifying Microbicide Gels: Effects on Markers of Inflammation and Innate Immunity in Cervicovaginal Fluid

AMERICAN JOURNAL OF REPRODUCTIVE IMMUNOLOGY, Issue 2 2009
Deborah J. Anderson
Objective, Diaphragms are being considered for use with vaginal microbicide gels to provide enhanced protection against sexually transmitted pathogens. The purpose of this study was to determine whether use of a diaphragm with microbicide or placebo gel causes cervicovaginal inflammation or perturbations in cervicovaginal immune defense. Method of study, Eighty-one non-pregnant women were randomized into three groups and instructed to use Milex® (CooperSurgical, Inc., Trumbull, CT, USA)diaphragms overnight for 14 days in combination with one of the two acid-buffering microbicide gels [ACIDFORMÔ (Instead Inc., La Jolla, CA, USA) or BufferGelÔ (BG; ReProtect Inc., Baltimore, Maryland)] or placebo gel (K-Y Jelly®; Personal Products Inc., Raritan, NJ, USA). Cervicovaginal lavages (CVLs) were performed prior to study entry and on days 8 and 16. Nine soluble mediators of vaginal inflammation or immune defense were measured in CVLs by Bio-Plex or ELISA. Results, Use of diaphragms with placebo or microbicide gel was not associated with increased levels of inflammation markers. Concentrations of secretory leukocyte protease inhibitor (SLPI) were markedly reduced in the BG group. Conclusion, Daily use of a diaphragm with placebo or acidifying microbicide gel did not cause cervicovaginal inflammation. However, diaphragm/BG use was associated with markedly reduced levels of SLPI, an important mediator of innate immune defense. Further studies are warranted to establish the safety of diaphragm/microbicide gel combinations. [source]

Evaluation of a needle-free injection system for local anaesthesia prior to venous cannulation

ANAESTHESIA, Issue 3 2000
J. A. Cooper
We evaluated a single-use, disposable, carbon-dioxide-powered, needleless injector (J-Tip, National Medical Products Inc., CA, USA), which is claimed to deliver a virtually painless, subcutaneous injection. Seventy-two patients undergoing various types of surgery had a large-bore intravenous cannula inserted prior to induction of general anaesthesia. Three minutes beforehand, a subcutaneous injection of 0.3 ml of 1% plain lidocaine was administered. Subjects were randomly allocated to receive the lidocaine either by the needleless injector or from a conventional syringe and a 25G needle. Pain scores were recorded on injection of the lidocaine and on insertion of the cannula. There was significantly less pain on injection with the needleless injector than with the 25G needle (p < 0.001) but, surprisingly, there was more pain on cannulation (p < 0.001). We conclude that the device certainly delivers a less painful subcutaneous injection than a 25G needle, but perhaps provides less effective skin anaesthesia for venous cannulation at sites where the subcutaneous space is small; its use might be better suited to areas where the subcutaneous space is deeper. [source]