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LETTER TO EDITOR
Year : 2013  |  Volume : 1  |  Issue : 1  |  Page : 40-41

Randomized controlled trials: The apple of researchers' eyes in oral health


Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Brazil

Date of Web Publication29-Apr-2013

Correspondence Address:
Rafael Sarkis-Onofre
Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas
Brazil
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2321-4619.111233

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How to cite this article:
Sarkis-Onofre R, Skupien JA, Pereira-Cenci T. Randomized controlled trials: The apple of researchers' eyes in oral health. J Res Dent 2013;1:40-1

How to cite this URL:
Sarkis-Onofre R, Skupien JA, Pereira-Cenci T. Randomized controlled trials: The apple of researchers' eyes in oral health. J Res Dent [serial online] 2013 [cited 2019 Nov 21];1:40-1. Available from: http://www.jresdent.org/text.asp?2013/1/1/40/111233

Sir,

Based on the concept proposed by Mashelkar in 2005, [1] the economic strength of a country is compared with its autochthonous research capacity. The Brazilian Government increased research and technology funding through federal agencies, stimulating public and private partnerships. Today, Brazil is the 15 th country in the world in number of publications, surpassing countries as Israel and Switzerland [2] which are considered developed countries. Is this amount, however, proportional to the quality of evidence generated?

According to the American Dental Association [3] the randomized controlled trials (RCTs) are considered to be the highest quality of evidence for the safety and effectiveness of a therapeutic or preventive intervention. But this is only true if some aspects of the RCT are reached: Volunteers randomly assigned to the study groups; an intervention or control treatment is administered to all individuals in the respective groups; the study must be prospective; and the success of the test intervention versus the control is judged based on an outcome that is specified before the trial begins. [4]

Due to the importance of this type of study, the number of clinical trials has increased in the last years. Unfortunately, several studies are presenting poor design. As a result, experts showed that RCTs had a quality far below the ideal and suggested in 1996 the Consolidated Standards of Reporting Trials (CONSORT), also known as the CONSORT statement. The aim of the CONSORT statement is to increase the quality and report of trials through a standardization of critical points (homogeneity), trying to avoid that some publications could still present problems in their experimental design, and facilitate comparisons among several studies, providing meta-analyses, the best level of evidence in dentistry. [4]

Today, most scientific health journals supports the policies of the World Health Organization and the International Committee of Medical Journal Editors for the registration of clinical trials and only registered trials (in databases as Clinicaltrials.gov and/or International Standard Randomized Controlled Trial Number) are accepted for peer review and publication. Despite being the 15 th country in the world in number of publications, RCTs are not a reality in Brazilian Research yet. From a more realistic perspective, although a total of 118,000 trials registered on Clinicaltrials.gov database, only 2600, less than 5%, are registered as Brazilian trials. More interestingly, only 53 trials are registered as belong to dentistry. [5]

These data can be justified by the fact that the RCTs require methodologies that involve a great amount of work, high budgetary costs (grants), and occupy scientists' and patients' time, unlike in vitro methodologies. [4] Furthermore, a possible reason why this may happen is because for some researchers, especially beginners, the amount of published papers could be sometimes more important than the impact of the outcomes of research on scientific community. Thus, Brazilian Government is stimulating a new approach, with a careful look at the journals' impact factor.

Therefore, RCTs should be looked with other eyes, as a way of consolidation of Brazilian Research worldwide. RCTs should be the apple of researchers' eyes in dental research.

 
  References Top

1.Mashelkar RA. Nation building through science and technology: A developing world perspective. 10 th Zuckermann lecture. Innov Strat Today 2005;1:16-32. Available from: http://www.biodevelopments.org/innovation/index.htm. [Last cited 2011 Dec 27].  Back to cited text no. 1
    
2.Thomson Reuters [homepage]. Top 20 Countries in ALL FIELDS. New York: Thomson Reuters; 2011. Available from: http://www.sciencewatch.com/dr/cou/2011/11decALL/. [Last cited 2012 Jan 03].  Back to cited text no. 2
    
3.American Dental Association [homepage on the internet]. ADA Policy Statement on Evidence-Based Dentistry. Chicago: Policy on Evidence-Based Dentistry 2008. Available from: http://www.ada.org/1754.aspx. [Last cited 2011 Dec 27].  Back to cited text no. 3
    
4.Consort - Transparent Reporting of Trials [homepage on the internet]. Consort - Transparent Reporting of Trials; History. 2011. Available from: http://www.consort-statement.org/about-consort/history/. [Last cited 2011 Dec 27].  Back to cited text no. 4
    
5.ClinicalTrials.gov [homepage on the internet]. Basic search. USA: ClinicalTrials.gov; 2011. Available from: http://www.clinicaltrials.gov/. [Last cited 2011 Dec 27].  Back to cited text no. 5
    




 

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