“How can we truly determine whether a whitening toothpaste lives up to its claims? Does a foam genuinely deliver freshness and improve breath quality? Can an ingredient effectively support the oral microbiome’s balance? In today’s cosmetic landscape, where scientific validation and performance are no longer optional but essential, the rigorous evaluation of product claims has never been more critical.”
The oral care industry is experiencing a major shift, fueled by consumer demand for advanced benefits, from enamel-whitening innovations to microbiome-supportive formulas and enhanced sensory experiences. As the lines between traditional oral hygiene products and high-performance solutions continue to blur, the market is increasingly embracing beauty-focused benefits and near-medical advancements. To meet both regulatory standards and consumer expectations for proven efficacy, the need for reliable, standardized evaluation methods has never been greater. For cosmetic brands and testing labs, validating claims like “whitening,” “polishing,” “anti-plaque,” or “12-hour fresh breath” requires not only scientific rigor but also a deep understanding of regulatory compliance.
Though oral care often overlaps with dental medicine, the cosmetic sector has its own distinct focus, regulations, and evaluation standards. Cosmetic claims must center on non-therapeutic benefits, like improving appearance, hygiene, or sensory qualities, without implying disease prevention or treatment. This creates a unique environment where innovation must be backed by clear, measurable evidence, all while staying within the boundaries of what defines a cosmetic product. With hygiene routines evolving and new trends emerging, the industry faces two key challenges: keeping up with fast-moving technological advancements and consumer demands and pinpointing the most effective and reliable testing methods in an increasingly diverse and complex landscape.
Platforms such as Skinobs Clinical Testing, which reference hundreds of laboratories worldwide and map evaluation methodologies across categories, provide an increasingly important resource for R&D, evaluation, and regulatory teams navigating oral care assessment.
1. The Cosmetic Scope of Oral Care: Defining the Boundaries
Cosmetic oral care encompasses products intended to clean, whiten, freshen, polish, or cosmetically enhance the appearance of teeth, lips, and mouth, without exerting therapeutic or restorative effects. Typical categories include:
- Toothpastes and gels with aesthetic benefits (whitening, polishing, brightening)
- Mouthwashes for breath freshening and hygienic claims
- Whitening strips and cosmetic bleaching agents (non-medical concentrations)
- Devices such as LED whitening tools
- Oral foams, sprays, and powders
- Cosmetic anti-stain or anti-plaque formulations
- Microbiome-friendly oral care cosmetics
On the other hand, the following are considered medical, not cosmetic applications: preventing cavities (using therapeutic fluoride levels), treating gingivitis, periodontitis, or tooth erosion, alleviating tooth sensitivity, and products that modify the mouth’s physiological functions.
Distinguishing between these categories is not merely semantic, it directly shapes claim substantiation strategies. Cosmetic oral care claims must be supported by evidence demonstrating visible, sensory, or hygiene-related effects, without implying risk reduction or disease therapy.
2. Evaluation Approaches for Cosmetic Oral Care Products
The evaluation of cosmetic oral care products spans in vitro, in vivo, in silico, and instrumental methodologies. The careful selection and combination of methods are essential to ensure the scientific validity of product claims.
2.1 In-vitro methods
In vitro tests are widely used for initial screening, mechanism-of-action studies, and early claim orientation.
- Enamel blocks to assess whitening, remineralization, and stain removal potentials
- Artificial saliva and biofilm models for plaque adhesion and cleaning efficiency
- Colorimetric technologies measuring color changes on treated enamel surfaces
- Microbiome and antimicrobial assays, used specifically for cosmetic hygiene or odor-control claims
- Erosion-abrasion models for evaluating polishing or enamel-surface smoothing benefits
These assays provide controlled, reproducible data, though they can be complemented by studies on humans.
2.2 In vivo clinical evaluation
Human clinical studies remain the cornerstone for claim substantiation, particularly for whitening, polish, hygiene, and breath-freshness claims.
Whitening and Brightening
The most frequently used methods include:
- Shade guide scoring (VITA, digital shade guides)
- Instrumental colorimetry (e.g., spectrophotometers, intraoral scanners, digital imaging)
- Professional grading for stain removal and surface brightness
- Standardized photography with controlled lighting and calibration tools
These approaches quantify color variations to demonstrate measurable cosmetic improvement.
Anti-plaque Claims
- Plaque indices (Silness-Löe, Quigley & Hein)
- Digital plaque imaging by fluorescence
- Biofilm quantification using image-analysis software
Since plaque-related diseases fall under the medical realm, cosmetic claims must focus on removing visible plaque, reducing adhesion, or providing a cleaner-feeling mouth, avoiding any references to prevention of gingivitis or caries.
Breath Freshening
Breath evaluation requires both instrumental and sensory methodologies:
- Gas chromatography for volatile sulfur compounds
- Electronic noses
- Trained sensory panels rating freshness duration and intensity
Such data support claims like “long-lasting fresh breath” or “immediate deodorizing effect”.
Surface Polishing and Smoothing
Perceived smoothness is closely linked to cosmetic brightness.
- Profilometry
- Scanning electron microscopy (SEM) for surface morphology
- Roughness indices (Ra, Rz) before and after product use
These can support claims related to smoothness, gloss, and stain resistance.
2.3 Sensory and Consumer Perception Studies
For holistic substantiation, consumer perception studies are essential:
- Self-assessment questionnaires
- Home-use tests
- Sensory evaluation of texture, taste, foam, and immediate feel
While subjective, these studies provide pragmatic insights into consumer-relevant attributes such as “clean feeling,” “freshness,” and “instant brightness.”
3. Modeling the Oral Microbiome: A Rising Priority
Microbiome-oriented oral care is one of the fastest-growing categories. Cosmetic microbiome claims focus on:
- Supporting a balanced oral ecosystem
- Limiting odor-causing bacteria (without implying antimicrobial therapy)
- Respecting oral microbiota diversity
- Using prebiotics or postbiotics to encourage non-pathogenic flora
The evaluation of these claims requires the analysis of the microbiome with a biofilm co-culture after sampling by: high-throughput sequencing (16S rRNA), metabolomic profiling, targeted qPCR for specific bacterial strains. The challenge is ensuring positioning remains cosmetic rather than therapeutic, especially when consumers increasingly associate microbiome health with medical outcomes.
Regulatory Considerations for Claims Substantiation
Although oral care lies at the intersection of health and beauty, cosmetics must strictly adhere to cosmetic claims and comply with cosmetic regulations (such as EU 655/2013 in Europe), rather than addressing physiological or pathological criteria. To avoid claims at the border of the medical, brands must essentially formulate the benefits around the appearance, the brightness, the sensory aspects, of hygiene and freshness, the surface characteristics.
- Claims must not imply disease prevention or treatment
- Efficacy must be demonstrated using appropriate and robust methods
- A product information file (PIF) must include all test data
The Diversity of Methodologies and the Need for Centralized Access
As innovation accelerates, the oral care evaluation landscape becomes more fragmented, with laboratories offering increasingly specialized technologies, from AI-driven imaging to next-gen microbiome sequencing.
For R&D, formulation teams, clinical testing managers, and claim substantiation experts, identifying the right laboratory or method can be complex. This is where centralized platforms become pivotal.
On Skinobs Clinical Testing Platform, you can find 11 testing solutions and more than 54 providers for beauty oral care evaluations. With 11 claims such as anti-gingivitis, whitening, anti-tartar… and 54 services providers, you have all the tools to compare approaches and identify CROS aligned with specific claim strategies.
This centralized access allows industry professionals to streamline test design, benchmark methodological options, and ensure that claims are substantiated with rigorous and appropriate data.
Future Perspectives in Cosmetic Oral Care Evaluation
The evaluation of cosmetic oral care products is advancing through scientific and technological innovations. AI-driven imaging and digital twins enable precise plaque analysis and whitening outcome predictions, enhancing testing reliability. Connected sensors provide real-time monitoring of brushing habits and stain accumulation, supporting personalized oral care routines. Sustainability and sensory experience are now central, with formulations emphasizing natural ingredients and refined textures, requiring new evaluation methods. Additionally, microbiome-friendly technologies are gaining prominence, necessitating clear regulatory frameworks to ensure claims remain within the cosmetic domain without medical implications.
In conclusion, cosmetic oral care is rapidly expanding and diversifying, fueled by innovation, sensorial expectations, and consumer focus on visible brightness, freshness, and hygiene. As regulatory boundaries tighten and claim substantiation become more rigorous, the industry increasingly depends on robust, standardized, and scientifically grounded evaluation methodologies.
By mapping a broad spectrum of available methods and referencing a large global network of laboratories, platforms such as Skinobs Clinical Testing play a strategic role in helping brands navigate the complexity of oral care assessment. Whether developing a whitening toothpaste, a microbiome-friendly mouth rinse, or a cosmetic LED device, professionals across formulation, regulatory, evaluation, and marketing can benefit from clearer visibility of the testing panorama.
As the field continues to evolve, harmonized methodologies, advanced digital tools, and holistic evaluation strategies will shape the next generation of cosmetic oral care innovations.
CONTACT
Anne Charpentier – CEO & Founder
www.skinobs.com
