Abstract
Traditionally, dentine hypersensitivity (DH) has been assessed with both objective and subjective measures in clinical studies designed to evaluate the efficacy of desensitising products. The importance of conducting well-designed randomised controlled trials (RCTs) has been emphasised by both clinical investigators and regulatory bodies in Europe and the USA (e.g. ADA, FDA, ICP/GCP). One of the major problems however in assessing the level of pain associated with DH is the highly subjective nature of the condition which makes it extremely difficult for the clinician to evaluate the problem objectively in the clinical environment. Furthermore, the evaluation of the pain response from participants in clinical studies is particularly problematic, and this may be due to a number of issues, for example, the highly subjective nature of the problem and the influence of both Hawthorne and placebo/nocebo effects throughout the duration of the study. Other factors that may also impact on these studies include the lack of statistical power (small sample size) and lack of standardisation of the methodology used to determine treatment outcomes. More recently, however, the focus in assessing the subject’s pain response whether in the research or practice-based environment has shifted from a biomedical model to a person-centred approach.
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Curro, F.A., Gillam, D.G. (2015). Challenging the Traditional Approach for the Conduct of Dentine Hypersensitivity Studies: Person-Centric Studies Connecting the Patient with Their Practitioner to Optimise the Clinical Outcome. In: Gillam, D. (eds) Dentine Hypersensitivity. Springer, Cham. https://doi.org/10.1007/978-3-319-14577-8_7
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