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.