Document
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Continuant
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Split-mouth design in Paediatric Dentistry clinical trials
freetext keyword: Clinical trials; Paediatric Dentistry; Split-mouth design; Treatment comparison clinical trial (topic); dentistry; human; methodology; sample size; Clinical Trials as Topic; Humans; Pediatric Dentistry; Research Design; Sample Size
pmid: 28494606
type: Information Content Entity
abstract: Aim The aim of this article was to describe the essential concepts of the split-mouth design, its underlying assumptions, advantages, limitations, statistical considerations, and possible applications in Paediatric Dentistry clinical investigation. Discussion In Paediatric Dentistry clinical investigation, and as part of randomised controlled trials, the split-mouth design is commonly used. The design is characterised by subdividing the child%27s dentition into halves (right and left), where two different treatment modalities are assigned to one side randomly, in order to allow further outcome evaluation. Each participant acts as their own control by making within-patient rather than between-patient comparisons, thus diminishing inter-subject variability and increasing study accuracy and power. However, the main problem with this design comprises the potential contamination of the treatment effect from one side to the other, or the carry-across effect; likewise, this design is not indicated when the oral disease to be treated is not symmetrically distributed (e.g. severity) in the mouth of children. Thus, in spite of its advantages, the split-mouth design can only be applied in a limited number of strictly selected cases. Conclusion In order to obtain valid and reliable data from split mouth design studies, it is necessary to evaluate the risk of carry-across effect as well as to carefully analise and select adequate inclusion criteria, sample-size calculation and method of statistical analysis.
page start: 61
type: Entity
crisid: 4892
type: Thing
abstract: Aim The aim of this article was to describe the essential concepts of the split-mouth design, its underlying assumptions, advantages, limitations, statistical considerations, and possible applications in Paediatric Dentistry clinical investigation. Discussion In Paediatric Dentistry clinical investigation, and as part of randomised controlled trials, the split-mouth design is commonly used. The design is characterised by subdividing the child's dentition into halves (right and left), where two different treatment modalities are assigned to one side randomly, in order to allow further outcome evaluation. Each participant acts as their own control by making within-patient rather than between-patient comparisons, thus diminishing inter-subject variability and increasing study accuracy and power. However, the main problem with this design comprises the potential contamination of the treatment effect from one side to the other, or the carry-across effect; likewise, this design is not indicated when the oral disease to be treated is not symmetrically distributed (e.g. severity) in the mouth of children. Thus, in spite of its advantages, the split-mouth design can only be applied in a limited number of strictly selected cases. Conclusion In order to obtain valid and reliable data from split mouth design studies, it is necessary to evaluate the risk of carry-across effect as well as to carefully analise and select adequate inclusion criteria, sample-size calculation and method of statistical analysis.
e iscopus: 2-s2.0-85018982964
has publication venue: European Journal of Paediatric Dentistry
type: Article
type: Continuant
origen: scopus
most specific type: Document
related by: authorship_29379
volume: 18
type: Document
most specific type: Article
related by: authorship_29381
estado: published
type: Generically Dependent Continuant
page end: 65
issue: 1
related by: authorship_29380
date time value: article date 4892

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RDF description of Split-mouth design in Paediatric Dentistry clinical trials - http://orbis.uaslp.mx/vivo/individual/scopus4891
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date: 2026-08-26T03:41:27
publisher: vivo
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Article
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European Journal of Paediatric Dentistry
publication venue for: Split-mouth design in Paediatric Dentistry clinical trials
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Information Content Entity
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