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<0.0001). Good level of inter-operator agreement was observed for Tanita HC-205, Vita Easyshade V and Vita Classical Shade Guide with Fleiss’ multirater kappa of 0.66, 0.73 and 0.72, respectively (all p<0.001). Very good inter-observer agreement was observed between scorers for extrinsic stain score, while good agreement was found for plaque index and gingival index with Fleiss’ multirater kappa of 0.84, 0.71 and 0.73, respectively (all p<0.001).

Conclusion: Method validation conducted in present study can serve as a reliable model for future dental clinical studies on oral or dental care products, ensuring consistent, accurate, and reproducible results. It further highlights the importance of controlled testing methods, essential for the successful execution of efficacy studies on dental care products.