Artificial Lesion Preparation for In Vitro Remineralisation and Demineralisation Studies

Artificial lesion preparation is the initial stage of an in vitro oral care product study to assess tooth remineralisation or demineralisation performance for an oral care product such as a toothpaste or mouth rinse. If you are developing a new oral care product with associated remineralisation function and marketing claims, then the relative efficacy of your dentifrice formulation to repair demineralised tooth enamel can be compared using in vitro models and laboratory testing.

Fluoride is often the active agent of choice in such dentifrices though other agents may also assist in enamel repair. Lesions are areas of decalcified tooth enamel which may develop into dental caries or be precursors to dental erosion. In vitro remineralisation and demineralisation studies are a cost-effective alternative to clinical trials that can guide formulation development and support product claims.

Our experts can provide artificial lesion preparation to support in vitro studies of enamel remineralisation. We can design and carry out bespoke studies that meet your particular product requirements, whether they are for a toothpaste, mouthrinse, gel or other type of dentifrice, alternatively we can provide you with lesions so that you can carry out your own in vitro studies.

Within our dedicated oral care testing laboratory, we can produce artificial lesions in bovine or human enamel or dentine in a wide variety of shapes and sizes. Lesion ‘windows’ can be created by protecting the sides and undersides of the substrates with dental wax or protective coatings. We are also able to provide you with thin cross-sections for analysis by microradiography.

Our expertise in developing robust protocols or adopting literature-sourced protocols means we can tailor the protocol to your specific product application instructions. We can produce quick and simple acid-induced lesions or alternatively produce lesions over a period of several days by incubation in acid gels. These can then be used in enamel remineralisation models (pH cycling) and be measured using surface microhardness or microradiography.

Total Quality Assurance
Our Clinical Research Services (CRS) team have a dedicated in vitro laboratory which conducts testing of all aspects of Oral Care products. We are particularly adept in designing bespoke in vitro models to cater for your specific requirements. Intertek Clinical Research Services is licensed to handle and store human tissue under the Human Tissue Act 2004 and follows the principles outlined within the act as well as complying with local ethical guidelines.

For over 20 years our Clinical Research Services group has been a trusted partner for developers and manufacturers of oral care products. We provide a one-source solution for in vitro studies providing robust data to support the efficacy of novel treatments enabling our customers to power ahead safely.