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Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials


Pandis, Nikolaos; Walsh, Tanya; Polychronopoulou, Argy; Katsaros, Christos; Eliades, Theodore (2013). Split-mouth designs in orthodontics: an overview with applications to orthodontic clinical trials. European Journal of Orthodontics, 35(6):783-789.

Abstract

Split-mouth designs first appeared in dental clinical trials in the late sixties. The main advantage of this study design is its efficiency in terms of sample size as the patients act as their own controls. Cited disadvantages relate to carry-across effects, contamination or spilling of the effects of one intervention to another, period effects if the interventions are delivered at different time periods, difficulty in finding similar comparison sites within patients and the requirement for more complex data analysis. Although some additional thought is required when utilizing a split-mouth design, the efficiency of this design is attractive, particularly in orthodontic clinical studies where carry-across, period effects and dissimilarity between intervention sites does not pose a problem. Selection of the appropriate research design, intervention protocol and statistical method accounting for both the reduced variability and potential clustering effects within patients should be considered for the trial results to be valid.

Abstract

Split-mouth designs first appeared in dental clinical trials in the late sixties. The main advantage of this study design is its efficiency in terms of sample size as the patients act as their own controls. Cited disadvantages relate to carry-across effects, contamination or spilling of the effects of one intervention to another, period effects if the interventions are delivered at different time periods, difficulty in finding similar comparison sites within patients and the requirement for more complex data analysis. Although some additional thought is required when utilizing a split-mouth design, the efficiency of this design is attractive, particularly in orthodontic clinical studies where carry-across, period effects and dissimilarity between intervention sites does not pose a problem. Selection of the appropriate research design, intervention protocol and statistical method accounting for both the reduced variability and potential clustering effects within patients should be considered for the trial results to be valid.

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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Center for Dental Medicine > Clinic for Orthodontics and Pediatric Dentistry
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2013
Deposited On:03 Feb 2014 17:00
Last Modified:07 Dec 2017 08:30
Publisher:Oxford University Press
ISSN:0141-5387
Free access at:Publisher DOI. An embargo period may apply.
Publisher DOI:https://doi.org/10.1093/ejo/cjs108
PubMed ID:23376899

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