Intertek is the industry leader with over 42,000 people in 1,000 locations in over 100 countries. Whether your business is local or global, we can ensure your products meet quality, health, environmental, safety, and social accountability standards for virtually any market around the world.
Dental clinical study investigator site support for pharmaceutical, consumer healthcare or medical device GCP efficacy and safety assessment
Dental clinical trials enable the clinical development of medicines or medical devices for the treatment of oral health conditions and diseases which affect the oral cavity. Robust and credible scientific clinical trials, conducted to Good Clinical Practice (GCP) guidelines, are required to support safety and efficacy studies for pharmaceuticals, over-the-counter medicines, consumer healthcare and medical devices. Responsive participant recruitment and dedicated clinical trial managers are critical to achieving your development milestones and delivering study outcomes to meet clinical quality standards.
Our dental clinical trial team provides GCP compliant investigator site study services to address dental indications such as dentine hypersensitivity, periodontitis, dental caries, gingivitis and treatment of other oral soft tissues diseases.
Intertek’s experienced dental clinicians establish a robust evidence base for a dental treatment and, in particular, support your Phase II to Phase IV clinical studies for new medicines, consumer healthcare products and medical devices which are being developed to treat conditions and diseases that affect the teeth and gums and other oral tissues. We apply efficient and appropriate approaches to trial methodology for dental research applications working to the EU Directive 2001/20/EC (Clinical Trials Directive), the EU Directive 2005/28/EC (GCP Directive), The Medicines for Human Use (Clinical Trial) Regulations 2004 and its subsequent amendments and also the ISO 14155 Clinical Investigation of Medical Devices guidelines.
Our participant database is one of the largest in the industry and currently includes over 14,000 participants. We are able to select participants based on age, gender, oral hygiene regime, oral health and common ailments. Our study management expertise ensures that participants are compliant with study restrictions.
We are one of the world’s largest CROs for the provision of dental clinical studies delivering robust clinical data to support the efficacy and safety of pharmaceuticals, over-the-counter pharmaceuticals, consumer healthcare and medical devices.
Dental Clinical Facilities
Intertek clinical research facilities comprise five sites in the UK that offer an optimal blend of practicality and flexibility. All sites have the capability to accommodate GCP studies in different indications with high quality clinical spaces including oral care suites, private examination rooms, interview areas, sample preparation and dosing stations. The versatility of our sites and staff allow us to maximize project scheduling opportunities by providing equivalent facilities and skills across a variety of locations.
Experienced Dental Assessors
We conduct over 35 oral care clinical studies per year, which means that examiners’ assessment skills are utilised regularly. With regular, structured calibration programs we ensure consistency amongst assessors and provide robust data to measure variability among and between our assessors which enables optimization of our clinical assessment processes.
In vitro and Bioanalytical Expertise
Our laboratories also provide in-house comprehensive GCP and Good Laboratory Practice (GLP) compliant bioanalytical solutions which include gingival crevicular fluid analysis, active ingredient analysis in plaque and saliva samples and antibacterial assessments. Our bioanalytical laboratories are inspected and licensed by the Human Tissue Authority (HTA) and by the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for GLP and Good Clinical Practice (GCP) compliant bioanalytical services for the evaluation of clinical samples.
Dental plaque is considered to be a key aetiological factor in caries and gingivitis. Our assessors are familiar with a number of indices including Quigley and Hein, Loe & Silness and Navy to name a few. Additionally, we regularly conduct plaque sampling and analysis (microbiology, active agent deposition etc).
Sub-optimal oral hygiene may lead to gingivitis and a number of products aim to control this condition. We have experience of a number of study designs from 21 day, through to six months and are experienced in several indices including Gingival Index and Bleeding indices. Gingival Crevicular fluid sampling and elution can be conducted as required.
Dentinal hypersensitivity is a common and painful condition. Accurate diagnosis of the cause of any painful stimuli to exclude non-dentinal hypersensitivity aetiologies is key to running successful clinical trials in this area. Examples of indices used are Thermal stimuli as well as Pressure stimuli.
The removal of calculus remains the preserve of the dentist and hygienist. Controlling build- up of Calculus by both chemotherapeutic and mechanical means can be measured using the Volpe-Manhold Index.
We have an in-situ model which allows assessment of enamel and dentine abrasion on real dental tissue, subjected to the rigours of a normal oral environment. Example methodologies are in situ enamel wear, in situ dentine wear and in vivo toothbrush abrasion (soft tissue).
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+44 (0) 151 347 4810
Our clinical trial services for medicines and medical devices include specialist capabilities in dentistry, dermatology, podiatry and wound management. Led by experienced investigators, our multi-disciplined clinical teams provide robust, GCP compliant studies to support your consumer healthcare products, over-the-counter medicines, and medical devices.