Oral Care Clinical Testing for Cosmetics and Personal Care Products

Oral care clinical studies by expert dental assessors who test consumer products for end-points including plaque removal, tooth whitening and stain removal

Oral care product clinical testing can play a critical role in research and development leading to innovative oral care products and can help to ensure the safety and efficacy of your dental care products. Consumers are increasingly demanding safe and effective high-quality cosmetic and healthcare products.

As a consumer healthcare or cosmetic manufacturer, it is important to instil confidence in your brands to ensure a loyal customer base and solid market share. In addition, claims on safety and efficacy need to be robust enough to undergo the scrutiny of the advertising standards agency.

 

For over 20 years our oral care product Clinical Research Services group has offered Total Quality Assurance and has been a trusted partner for developers and manufacturers of oral care products conducting studies using industry standard dental indices to measure plaque, gingivitis, stain and whitening, oral malodour, dentinal hypersensitivity, dental abrasivity and oral tolerance, assessing effectiveness against multiple claims where required.

Our team of qualified dental assessors conduct over 35 oral care clinical studies a year on products including toothpaste, toothbrushes, mouthwashes and dental floss. With regular, structured calibration programs we ensure consistency among assessors and provide robust data to measure variability among and between our assessors which enables optimization of our clinical assessment processes.

Our clinical services capabilities support the full life-cycle of the trial including protocol development, ethics committee review, participant recruitment, full study management, data management statistical analysis and reporting.

Our Clinical Research Services are ISO 9001 accredited, we operate a robust quality management system (QMS) to ensure reliable and credible scientific study data.  To achieve our quality objectives and to ensure continuous improvement our in-house dedicated Quality Assurance team are responsible for compliance with human testing guidelines.

Additionally, our laboratories also provide in-house bioanalytical support including sample analysis of oral care actives, in vitro method development, microhardness and hard tissue imaging and sampling techniques. We are inspected and licensed by the Human Tissue Authority (HTA).

Robust in vitro testing and analysis can support your product development by providing an assessment of product efficacy and safety. Our in vitro scientists conduct evaluation studies on  toothpastes, toothbrushes, interproximal devices, floss, mouthwashes, as well as bespoke design of cleaning, brushing, whitening, stain removal, erosion, abrasivity, sensitivity, calculus and active delivery models.

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 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.

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.

We are one of the world’s largest CROs for the provision of oral care product human trials, with 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 launches.

 

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.
The pursuit of a bright, white smile has led to an explosion of stain control and whitening products. We have considerable experience of a number of stain removal and tooth whitening clinical study protocols incorporating Lobene (MacPherson modification), Artificial stain build up, and Vita shade.
We have an in-situ model for dental abrasivity 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).
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.
Control of bad breath or malodour has been identified as a key consumer need. Intertek provides oral malodour studies with instrumental measurements of malodour.
Intertek has a number of in-situ models to assess the changes in microhardness of enamel and dentine.
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.
Need help or have a question? +44 (0) 151 347 4810
 

Need help or have a question?

+44 (0) 151 347 4810
Wirral (UK):
+44 (0) 151 347 4810