This paper considers the methods used in design and analysis of recent clinical trials of topical fluoride interventions designed to prevent the development of dental caries in children, with particular consideration given to issues related to cluster-randomized trials. Studies which met the inclusion criteria were recent clinical trials of topical fluoride interventions published since 1990, conducted in children under 16 years of age, with caries as the outcome variable. Papers not published in English were translated. Information was extracted from the published trial reports on the units of randomization and analysis. The papers were also studied to assess if reporting allowed the assessment of potential consent bias in cluster-randomized trials and the reproduction of sample size calculations. Fifteen trials published since 1990 were included, of which five were cluster randomized. Only 1 of the 5 accounted for the clustering in the analysis. For the other four trials, it was possible to calculate that values from 0.002 (for DMFS) and 0.08 (for being caries free) for the intracluster correlation coefficient within schools could result in statistically non-significant findings. 3 of the 5 cluster-randomized trials did not report the consenting procedure in enough detail to judge whether consent bias could be present. Only 1 of the total 15 trials reported a sample size calculation. In summary, researchers should be aware of the importance of correctly analyzing cluster-randomized data and thorough reporting of clinical trials according to the CONSORT guidelines.

Keywords:
Analysis, clinical trials, Design, clinical trials, Fluoride, caries prevention, Randomized controlled trials, caries prevention, Statistics, trial analysis
This content is only available via PDF.
© 2006 S. Karger AG, Basel
2006
Copyright / Drug Dosage / Disclaimer
Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.
You do not currently have access to this content.