Internal validation and standardization of methods for evaluating the safety and effectiveness of dental care products in research studies: Within dentistry

Abstract

Background: Numerous methods are available for assessing effectiveness of oral/dental care products in clinical studies. However, a persistent debate surrounds the preference for specific methodologies over others. Intra- and inter-examiner variability are major concerns in both instrumental and visual examinations, as they can significantly influence the outcomes obtained. Aim: This study standardised various techniques and methods used in dental clinical studies, to achieve bias-free, accurate, consistent and reliable outcomes. Methods: This standardization and validation study was carried out by internal staff of NovoBliss Research, post receiving training from panel of dentists and periodontists on various aspects of dental evaluations. Study included method validation for measurement of oral malodour, teeth-shade and scoring for teeth shininess, along with intra- and inter-operator reliability for common assessments in dental clinical studies. Analysis was carried out using SPSS version 26.0. Results: After receiving training, high intraoperator reliability and instrument accuracy was observed for Tanita HC-205 breath analyzer (90% similarity) for measuring malodour and for Vita Easyshade V (100% similarity) for determination of teeth shade. Shade determination through Vita Easyshade V and Vita Classical Shade Guide exhibited statistical similarity between their outcomes (p