Oral Malodour Studies

Oral malodour clinical trials using breath sample analysis to measure volatile sulphur compounds with OralChroma, Halimeter or Gas Chromatography

Products developed to control oral malodour or provide breath freshness require robust clinical study data to assess product efficacy and support claims.

Clinical study recruitment for halitosis measures can present a challenge in terms of volunteer selection criteria and participant compliance with study restrictions. The studies must be objective and meet strict clinical controls, underpinned by accurate and validated malodour measurements.

Our oral malodour clinical study capabilities support the full lifecycle of the trial including protocol development, ethics committee review, participant recruitment, full study management, breath sampling, laboratory measurements of human breath samples, data management statistical analysis and reporting. During the clinical trial, application of oral care product would be supervised and post-application breath measurements are carried out to determine volatile sulphur compounds (VSCs) levels at various time points with a focus on identifying if there is a statistically significant reduction.

A flexible approach to clinical delivery enables us to deploy demanding protocols for an oral malodour study including early morning measurements, closely supervised participants dosing and compliance. For standardized models, we can create a ring-fenced panel of selected participants to meet your study demands.

We measure volatile sulphur compounds (VSCs) using portable sulphide monitors (Halimeter, OralChroma). However, as oral malodour may comprise agents other than volatile sulphur compounds, we also provide gas chromatography (GC) analysis for a more accurate assessment of the total breath components. Our GC analysts are fully trained and our evaluations involve full statistical analysis of the data obtained.

Our Clinical Research Services are ISO 9001 accredited and 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 is responsible for compliance with human testing guidelines.

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, defense against legal challenges and product launches.

 
Our team of full-time dental assessors use industry dental indices assess product effectiveness against claims where required. We conduct many oral care clinical studies per year, which means that our 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.
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.
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