Validity issues in split-mouth trials

J Clin Periodontol. 1992 Oct;19(9 Pt 1):625-7. doi: 10.1111/j.1600-051x.1992.tb01709.x.

Abstract

The main purpose of the split-mouth design is to remove all components related to differences between subjects from the treatment comparisons. By making within-patient comparisons, rather than between-patient comparisons, the error variance (noise) of the experiment can be reduced, thereby obtaining a more powerful statistical test. Unfortunately, comparisons made on a within-patient basis have potential disadvantages. Treatments may have effects on experimental units other than those which they were assigned to (carry-across effects). Such effects cannot be estimated from split-mouth data. Neither can treatment effects be estimated. The estimable parameter in a split-mouth design is the treatment effect plus the sum of all carry-across effects. Unless a priori knowledge indicates that no carry-across effects exist, reported estimates of treatment efficacy are potentially biased. In the design of split-mouth clinical trials, potential gain in precision should be carefully weighed against a potential decrease in validity.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Humans
  • Models, Statistical*
  • Periodontal Diseases / therapy*
  • Reproducibility of Results
  • Research Design*
  • Treatment Outcome