An Introduction to Clinical Studies

This article is the first in a series about "Clinical Research". After this initial (general) introduction, further articles will guide you through the process of carrying out a clinical research study, from idea conception through protocol development, through statistical analysis of the results, and reporting in the literature.
 

 
The actual term "Clinical Research", is further categorised into "Pre-clinical" and actual "Clinical". Pre-clinical research includes such evaluations as physical properties testing, bond strength to tooth structure testing, wear testing, and handling properties. Pre-clinical testing is usually carried out in Biomaterials laboratories of dental schools. Although there are 55 dental schools in the U.S. and 10 dental schools in Canada, generally only a few are well suited to perform the required pre-clinical research by virtue of their expertise and their laboratory facilities. Pre-clinical research always requires the careful preparation of laboratory "specimens" in order to carry out the experiments, which are always outlined within a clearly defined protocol. The preparation of specimens is a skill, which requires significant experience, and to which we must pay close attention in order to be comfortable with the validity of the outcome.

Actual "Clinical" research involves human subjects, and is generally preceded by pre-clinical research in order to establish some of the "outcome measures" or "endpoints" of the planned clinical investigation. Many different types of studies involving patients can be performed, which are categorised based on their study design. The design of the clinical investigation is critical to the ultimate meaning of the results, and will be discussed in detail in the next article in this column entitled "Clinical Research Design and the Meaning of its Results".

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Key Words: dental, dentist, dental research

 
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