QUALIFIED & TRUSTED

Clinical Studies Division

Our seasoned clinical research professionals, with over 17 years of experience, conduct industry-sponsored clinical research trials that investigate the safety and/or efficacy of dental solutions seeking to improve oral health, whether through detection, prevention or treatment of oral health diseases, or evaluation for cosmetic benefits. We plan, coordinate, execute and manage the full lifecycle of each clinical research trial safely and efficiantly, in accordance with current Good Clinical Practice guidelines (cGCP) and in compliance with the United States Code of Federal Regulations. Clinical research trials are overseen by an Institutional Review Board as required by federal law.

One specialty study type is salivary peroxide following the usage of whitening agents. This requirement of Health Canada is performed routinely by our clinic.

Another study designed to replace animal testing for the FDA is enamel remineralization from fluoride toothpastes. This type of study is required for all toothpastes on the market in the US if the company prefers not to perform animal testing.

Capabilities of Our Clinical Studies Team

All studies are conducted with certified, accredited, and licensed personnel

Customized protocol and study design planning

IRB submissions to an independent IRB with rapid start-up times (typically 1.5 to 3 weeks)

Data security and subject confidentiality

Ease of developing contracts (No requirement for publication rights or issues regarding data ownership)

Subject Recruitment and consenting

Infection control and supply chain support

Statistical analysis and detailed reports

Types of Studies

Our clinical trials are offered in product & new methodology development, safety, efficacy, claims substantiation, comparison, and ADA/FDA guideline studies. We offer both in-Vivo and in-Situ study designs for a variety of different testing models. All studies are conducted with trained and qualified clinical examiners and are conducted in compliance with the Belmont Report, Good Clinical Practice (GCP/ICH), Code of Federal Regulations, FDA information sheets, and are overseen by an Institutional Review Board as required by federal law.