Abstract
The split-mouth design used in some clinical trials make a randomization scheme on site level where two treatments are randomly assigned to sites of one of the two halves of the mouth. The aim of this review was to summarize guidelines for conducting split-mouth clinical studies in Restorative Dentistry. This is a review performed through scientific articles published between 2004 and 2014 indexed in MEDLINE, PubMed and Scielo databases. The study evaluated USPHS and FDI criteria. The current review showed the main characteristics used in split-mouth studies presented the Restorative Dentistry literature, as ethical aspects, sample calculation, methods of selection and evaluation patients, in order to provide a guideline for clinical conduction. It showed a standard of methodologies to enable comparison among studies. Keywords: Clinical studies, split-mouth design, dentistry.
Highlights
Since World War II experiments with human beings have become more delicate, creating several rules and ethical aspects to the increasing employment of patients as experimental subjects [1]
Investigators are responsible for all subjects enrolled in a trial, not just some of them, and the goals of the research are always secondary to the well-being of the participants. Those requirements are made clear in the Declaration of Helsinki of the World Health Organization (WHO), which is widely regarded as providing the fundamental guiding principles of research involving human subjects [1]
The split-mouth design used in some clinical trials make a randomization scheme on site level where two treatments are randomly assigned to sites of one of the two halves of the mouth [3]
Summary
Since World War II experiments with human beings have become more delicate, creating several rules and ethical aspects to the increasing employment of patients as experimental subjects [1]. Often the aim is to evaluate the effect of an experimental treatment on a site in the mouth, e.g. a tooth or a surface on a tooth, and this design seems useful The concept of this design was introduced in 1968 by Ramfjord et al in a periodontology study comparing two types of periodontal therapy by randomizing the treatment methods to half of each subject’s dentition divided by the mid-sagittal plane between the central incisor teeth [5]. Since this date, it has become increasingly popular in oral health research, once in a split-mouth design, divisions of the mouth (dental arches, quadrants, sextants or smaller subdivisions) constitute the experimental units randomly assigned to treatments.
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