Findings on Clinical Trials and Studies Detailed by Researchers at University of Washington (Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial)
By a News Reporter-Staff News Editor at Medical Letter on the CDC & FDA Data detailed on Clinical Research - Clinical Trials and Studies have been presented. According to news reporting out of Seattle, Washington, by NewsRx editors, research stated, "Dental caries (tooth decay) is a common disease in which the products of sugar metabolism by certain bacteria that populate the tooth surface induce the development and progression of lesions (cavities). This is a phase II single-centre randomised, double-blind, active-controlled, parallel-group trial to assess the efficacy of a combination povidone iodine and sodium fluoride dental varnish to determine if it is superior to a varnish containing only sodium fluoride in the prevention of new caries lesions."
Our news journalists obtained a quote from the research from the University of Washington, "The objective of this report is to describe the rationale and protocol for the trial. The study site is Pohnpei State, Federated States of Micronesia. The study population is 284 children 48-84 months old. The primary outcome will be the surface-level primary molar caries increment (dmfs/DMFS) at 2 years post baseline. The incremental dental caries at 1 year will also be compared between the two interventions. The secondary outcome is the Facial Image Scale after the initial treatment and after the fifth treatment at 1 year that gauges the child's response to the treatment. The Western Institutional Review Board (designated IRB) and the Institutional Review Board of the College of Micronesia-FSM approved all study procedures. The US Food and Drug Administration (FDA) has issued IND 128835 covering this study."
According to the news editors, the research concluded: "The study results will be published and submitted to the FDA in support of a new drug application."
For more information on this research see: Efficacy evaluation of an anti-caries varnish: protocol for a phase II randomised controlled trial. Bmj Open, 2017;7(6):e017866. (BMJ Publishing Group - group.bmj.com/; Bmj Open - bmjopen.bmj.com/)
Our news journalists report that additional information may be obtained by contacting P. Milgrom, Dept. of Oral Health Sciences, School of Dentistry, University of Washington, Seattle, Washington, United States. Additional authors for this research include O. Tut, M. Rothen, L. Mancl, M. Gallen and J.M Tanzer (see also Clinical Research - Clinical Trials and Studies).
Keywords for this news article include: Seattle, Dentistry, Washington, United States, Dental Caries, Clinical Research, North and Central America, Clinical Trials and Studies, Dental Diseases and Conditions.
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