Stain removal and tooth whitening clinical studies to evaluate oral care products and devices including toothpastes, gels strips and brushes
Stain removal and tooth whitening clinical studies help to test how effective a new whitening product is at removing stain from consumers’ teeth. The pursuit of a bright, white smile has led to an explosion of stain control and whitening products being developed. To support the launch of a stain removal or tooth whitening product, clinical trials are often used to substantiate marketing claims and demonstrate that they are safe for consumers.
Our stain removal and tooth whitening clinical studies assess the effectiveness of products for the removal of extrinsic tooth stains or teeth whitening in closely controlled trials. We also study oral hard/soft tissue assessment to establish the product’s safety. Intertek’s clinical study services incorporate risk-based study design, participant screening and recruitment, establishment of a baseline, participant dosing, oral care examinations, clinical data collection and management, statistical analysis and comprehensive reporting.
Intertek’s team of full-time dental assessors use industry recognised dental indices to measure stain removal and whitening during clinical studies such as Lobene (MacPherson modification) and Vita shade. We conduct over 35 oral care clinical studies per year and with regular, structured calibration programs we ensure consistency among and between our assessors and provide robust data to measure variability among and between our assessors which enables optimization of our clinical assessment processes. With the robust clinical data generated from our studies we can assess the statistical effectiveness against claims, in particular, with respect to removal of extrinsic stain, stain area and stain intensity.
We can incorporate artificial stain build-up as part of clinical studies where the trial participant would first undergo complete oral prophylaxis and then treatment with artificial staining agents. This helps to determine a baseline examination of stain accumulation which allows the assessment of the area and intensity of the stain and the percentage of stain affected sites.
We are one of the world’s largest CROs for the provision of oral care trials on consumer products, with Total Quality Assurance expertise in the recruitment and management of clinical trials to provide robust data to support your product development, marketing claims, defence against legal challenges and product launch. Our clinical study services are complemented by our in vitro expertise for anti-stain, stain removal and whitening testing.