Document Detail

The crossover design to evaluate the efficacy of plaque removal in tooth-brushing studies.
MedLine Citation:
PMID:  16212577     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: To evaluate the crossover clinical trial design to assess plaque removal efficacy of the Sonicare Elite. MATERIAL AND METHODS: A single-cohort, 12-week, two-treatment, single-blind, crossover clinical trial recruited 45 subjects. Plaque was recorded using the modified Quigley and Hein index plaque index (PI). After screening, subjects used the toothbrush for 2 weeks and were reminded to abstain from tooth cleaning 12-18 h prior to appointments. At visit two, subjects were randomized to 2 or 2(1/2) min. brushing time. PIs was recorded pre- and post-brushing. Subjects brushed for the allocated time for a further 2 weeks. At visit 3, PIs were recorded pre- and post-brushing. Two weeks later, at visit 4, the subjects crossed over and the protocol was repeated. RESULTS: There was no evidence of a learning effect within each arm of the crossover. A significant period effect was detected; however, no significant treatment by period effect was found. 2(1/2) min. brushing removed more plaque at full mouth (p=0.037), smooth (p=0.012) and lingual (p=0.002) sites compared with 2 min. CONCLUSION: The crossover design is a valid model for assessing plaque removal efficacy in tooth-brushing studies where no carry-over effect is clinically plausible.
G I McCracken; N Steen; P M Preshaw; L Heasman; F Stacey; P A Heasman
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Validation Studies    
Journal Detail:
Title:  Journal of clinical periodontology     Volume:  32     ISSN:  0303-6979     ISO Abbreviation:  J. Clin. Periodontol.     Publication Date:  2005 Nov 
Date Detail:
Created Date:  2005-10-10     Completed Date:  2005-12-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0425123     Medline TA:  J Clin Periodontol     Country:  Denmark    
Other Details:
Languages:  eng     Pagination:  1157-62     Citation Subset:  D; IM    
Copyright Information:
Copyright (c) Blackwell Munksgaard, 2005.
School of Dental Sciences, University of Newcastle upon Tyne, Newcastle upon Tyne, UK.
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MeSH Terms
Analysis of Variance
Cross-Over Studies
Dental Plaque / therapy*
Dental Plaque Index
Middle Aged
Single-Blind Method
Time Factors
Toothbrushing / methods*

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