Journal Article

Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it

Nikolaos Pandis, Argy Polychronopoulou and Theodore Eliades

in The European Journal of Orthodontics

Published on behalf of European Orthodontics Society

Volume 33, issue 6, pages 684-690
Published in print December 2011 | ISSN: 0141-5387
Published online February 2011 | e-ISSN: 1460-2210 | DOI: http://dx.doi.org/10.1093/ejo/cjq141
Randomization in clinical trials in orthodontics: its significance in research design and methods to achieve it

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Randomization is a key step in reducing selection bias during the treatment allocation phase in randomized clinical trials. The process of randomization follows specific steps, which include generation of the randomization list, allocation concealment, and implementation of randomization. The phenomenon in the dental and orthodontic literature of characterizing treatment allocation as random is frequent; however, often the randomization procedures followed are not appropriate. Randomization methods assign, at random, treatment to the trial arms without foreknowledge of allocation by either the participants or the investigators thus reducing selection bias. Randomization entails generation of random allocation, allocation concealment, and the actual methodology of implementing treatment allocation randomly and unpredictably. Most popular randomization methods include some form of restricted and/or stratified randomization. This article introduces the reasons, which make randomization an integral part of solid clinical trial methodology, and presents the main randomization schemes applicable to clinical trials in orthodontics.

Journal Article.  3641 words.  Illustrated.

Subjects: Restorative Dentistry and Orthodontics

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