Available online on 15.02.2025 at http://jddtonline.info

Journal of Drug Delivery and Therapeutics

Open Access to Pharmaceutical and Medical Research

Copyright  © 2025 The   Author(s): This is an open-access article distributed under the terms of the CC BY-NC 4.0 which permits unrestricted use, distribution, and reproduction in any medium for non-commercial use provided the original author and source are credited

Open Access Full Text Article   Research Article

Effectiveness of Alosteen Toothpaste: A Comprehensive Analysis

Rajdeep Dutta Gopal Dutta ¹*, Gautam Kar ², Juhita Bhattacharya ², Sarmistha Das ²

¹ Scientific Research Advisory Head, Renatus Wellness Pvt Limited, Bommanahalli, Bengaluru, Karnataka 5600681

² Ex Army & DRDO. Ex student AFMC(Pune) GDC (Bombay) INMAS (Delhi) Royal Academy London (UK) Manhattan (USA) University of Auckland (NZ)

³ R Ahmed dental College Kolkata

 

 

INTRODUCTION

Oral health is an integral part of general health, influencing both functional and aesthetic aspects of life. Tooth decay, gingivitis, and periodontitis are among the most common dental problems globally, affecting billions of people irrespective of age, gender, or geography ¹ (Petersen et al., 2005). Poor oral hygiene often leads to plaque buildup, which harbors pathogenic bacteria such as Streptococcus mutans, Porphyromonas gingivalis, and Candida albicans. These microorganisms are responsible for tooth decay, bad breath, and serious oral infections. As a result, the development of effective oral hygiene products remains a primary focus of dental research.

In recent years, the dental care industry has witnessed a surge in demand for toothpaste containing natural ingredients. This shift is driven by growing consumer awareness of the potential side effects of synthetic chemicals, such as sodium lauryl sulfate and triclosan, traditionally used in oral care products ² (Ahmed et al., 2020). Alosteen Toothpaste by Renatus Nova is a promising addition to this category, formulated with a blend of bioactive compounds and herbal extracts. The unique composition of Alosteen is designed to address multiple aspects of oral hygiene, including antimicrobial activity, antioxidant defense, and enamel protection.

Historical Context of Oral Hygiene

The history of oral hygiene dates back thousands of years, with ancient civilizations using rudimentary tools and natural substances to clean their teeth. The Egyptians, for example, are known to have used a mixture of powdered ashes, crushed eggshells, and pumice to maintain dental health ³ (Harris et al., 2007). Similarly, Ayurvedic medicine in India advocated the use of herbal formulations, including neem and clove, for their antimicrobial and anti-inflammatory properties. These traditional practices laid the foundation for modern oral care formulations that incorporate plant-based ingredients.

The Need for Innovative Toothpaste Formulations

Despite significant advancements in dental care, conventional toothpastes often fall short in addressing all aspects of oral health. Many products rely on fluoride as their primary active ingredient for cavity prevention, but excessive fluoride exposure can lead to dental fluorosis, particularly in children ⁴ (Dean, 1937). Additionally, synthetic abrasives and foaming agents can cause irritation to sensitive oral tissues, prompting the need for gentler, more effective alternatives.

Natural ingredients such as aloe vera, tea tree oil, and xylitol have gained popularity in oral care products due to their antimicrobial, anti-inflammatory, and remineralizing properties ⁵ (Chandrahas et al., 2017). Alosteen Toothpaste builds on this trend by combining these natural ingredients with advanced bioactive compounds, offering a holistic approach to oral hygiene.

Objectives of the Study

The primary objective of this study is to evaluate the effectiveness of Alosteen Toothpaste in promoting oral health. Specific goals include:

1. Assessing the antimicrobial activity of Alosteen against common oral pathogens, including Streptococcus mutans, Candida albicans, and Lactobacillus acidophilus.
2. Comparing the physical properties of Alosteen, such as pH, viscosity, and foamability, with those of marketed toothpaste.
3. Evaluating the antioxidant and anti-inflammatory properties of Alosteen to determine its potential therapeutic benefits.
4. Conducting stability tests to estimate the shelf life and durability of the product under varying environmental conditions.

The Science Behind Alosteen Toothpaste

Alosteen Toothpaste is formulated with a unique combination of herbal extracts and bioactive compounds, including:

• Neem Extract: Renowned for its antimicrobial properties, neem has been used in traditional medicine to combat bacterial and fungal infections ⁶ (Biswas et al., 2002).
• Xylitol: A natural sweetener with cavity-preventing properties, xylitol inhibits the growth of Streptococcus mutans by reducing bacterial adhesion to tooth surfaces ⁷ (Soderling & Salminen, 1993).
• Green Tea Extract: Rich in catechins, green tea provides antioxidant and anti-inflammatory benefits, protecting against gum diseases and oxidative stress ⁸ (Kim et al., 2011).
• Hydroxyapatite: A mineral component that mimics the natural structure of enamel, hydroxyapatite helps in remineralizing teeth and preventing demineralization ⁹ (Amaechi et al., 2009).

These ingredients are carefully blended to achieve a synergistic effect, enhancing the overall efficacy of the toothpaste. The incorporation of neem and green tea provides a natural antimicrobial barrier, while xylitol and hydroxyapatite work to strengthen and protect teeth.

Several studies have highlighted the advantages of incorporating natural ingredients into oral care products. For instance, a clinical trial by Singh et al. (2016) demonstrated that toothpaste containing neem extract significantly reduced plaque and gingivitis in participants over a 6-week period. Similarly, a meta-analysis by Milgrom et al. (2006) confirmed the cavity-reducing properties of xylitol in children. Green tea extract has also been shown to improve periodontal health by reducing inflammation and oxidative stress in the gums (Egashira et al., 2008) ^{10, 11, 12}.

Comparative studies between natural and synthetic formulations often reveal superior safety profiles for the former. For example, a study by Kumar et al. (2018) found that herbal toothpastes were less abrasive and caused less irritation to oral tissues compared to fluoride-based alternatives. These findings underscore the potential of Alosteen Toothpaste to fill a critical gap in the oral care market ¹³.

Hypothesis

Based on existing literature and preliminary test results, it is hypothesized that Alosteen Toothpaste will demonstrate superior antimicrobial, antioxidant, and anti-inflammatory properties compared to marketed toothpastes. Furthermore, its unique formulation is expected to enhance user satisfaction by offering a gentler, more effective alternative for daily oral care.

MATERIAL AND METHODOLOGY

2. Methodology

To evaluate the efficacy of Alosteen Tooth Gel, a series of tests were conducted to assess its physical, chemical, and functional properties in comparison to a marketed gel. The study included the following parameters:

2.1 pH Measurement:

The pH of the gel was measured using a calibrated pH meter to ensure its compatibility with oral health. Maintaining an optimal pH level is crucial to prevent enamel erosion and support oral microbiota balance. Safe pH ranges for oral products are between 5.5 and 7.5 (Jenkins et al., 2018) ¹⁴.

2.2 Viscosity Analysis:

The viscosity of Alosteen Tooth Gel was assessed using a Brookfield viscometer to determine its spreadability and adhesion properties. Proper viscosity ensures that the gel adheres to the tooth surface for an extended period, enhancing its cleaning efficacy (Smith & Brown, 2020) ¹⁵.

2.3 Foamability Test

Foam height was measured using a standardized shake test to evaluate the cleansing ability of the gel. Increased foam height is associated with better distribution of active ingredients and mechanical plaque removal (Williams et al., 2017) ¹⁶.

2.4 Relative Dentin Abrasivity (RDA):

The abrasiveness of the gel was determined using RDA testing to ensure it falls within safe limits for prolonged use. Excessive abrasiveness can lead to enamel erosion and dentin hypersensitivity (ISO 11609:2017) ¹⁷.

2.5 Antioxidant Activity:

Antioxidant activity was measured using the DPPH assay method, which evaluates the ability of the gel to neutralize free radicals and oxidative stress within the oral cavity. The presence of antioxidants helps to protect oral tissues from damage caused by reactive oxygen species, potentially reducing the risk of periodontal diseases and enhancing oral health. Alosteen demonstrated a significantly higher antioxidant activity (82.5%) compared to the marketed gel (68.7%), suggesting a stronger protective effect against oxidative stress. These findings align with studies by Jones et al. (2019), which emphasize the role of antioxidants in oral healthcare products.

2.6 Anti-inflammatory Activity:

The anti-inflammatory properties of Alosteen Tooth Gel were assessed using an in vitro enzyme inhibition assay to determine its effectiveness in reducing inflammation-related enzymes such as cyclooxygenase (COX) and lipoxygenase (LOX). Inflammation in the oral cavity, often resulting from bacterial infections, contributes to conditions such as gingivitis and periodontitis. The study showed that Alosteen exhibited superior anti-inflammatory activity (74.3%) compared to the marketed gel (60.8%), indicating its potential to alleviate gum inflammation and promote oral tissue health. These results are supported by previous research by Smith et al. (2020), highlighting the importance of anti-inflammatory agents in dental formulations ¹⁵.

2.7 Stability Testing:

The product's physical and chemical stability was evaluated over a three-month period under controlled environmental conditions, including temperature and humidity variations, to estimate its shelf life and ensure product consistency over time (FDA Guidelines, 2021) ¹⁸.

2.8 Antibacterial Activity Assessment:

The antibacterial efficacy of Alosteen Tooth Gel was tested against ten microbial strains, including Streptococcus mutans, Streptococcus sobrinus, Lactobacillus acidophilus, Porphyromonas gingivalis, Fusobacterium nucleatum, Actinomyces viscosus, Prevotella intermedia, Aggregatibacter actinomycetem comitans, Candida albicans, and Enterococcus faecalis. The agar well diffusion method was used, with Chlorhexidine (0.2%) serving as a standard antibiotic control (Johnson et al., 2016) ¹⁹.

3. RESULTS AND DISCUSSION

The test results indicate that Alosteen Tooth Gel outperforms the marketed gel across various parameters, demonstrating its potential as an effective oral care product.

 

 

Table 1: Basic tests parameters

 

Figure 2: Alosteen vs Marketed Gel

 

 

3.1 pH:

Alosteen (pH 6.8) maintained a slightly higher but safe pH compared to the marketed gel (6.5), which promotes enamel protection and supports a balanced oral environment (Jenkins et al., 2018) ¹⁴.

3.2 Viscosity:

The viscosity of Alosteen (3200 cP) was higher than the marketed gel (3100 cP), suggesting better adhesion and spreadability, which can contribute to longer contact time with oral surfaces and improved cleaning efficacy.

3.3 Foamability:

Higher foam production (15.2 cm vs. 13.5 cm) enhances cleansing action by helping to lift debris and plaque from the teeth. This aligns with findings from Williams et al. (2017), who emphasized the importance of foamability in oral hygiene products ¹⁶.

3.4 Abrasiveness:

The lower RDA value (92 vs. 110) indicates reduced abrasiveness, making Alosteen safer for long-term use. Excessive abrasiveness has been linked to enamel wear and dentin sensitivity, underscoring the importance of using low-RDA products (ISO 11609:2017) ¹⁷.

3.5 Antioxidant Activity:

The higher antioxidant capacity of Alosteen suggests better protection against oxidative stress, which is crucial for preventing oral diseases such as periodontitis and gingival inflammation. These findings corroborate previous studies that emphasize the importance of antioxidant-rich oral care products in maintaining oral health.

3.6 Anti-inflammatory Activity:

The superior anti-inflammatory properties of Alosteen Tooth Gel provide an added benefit in managing gum-related issues and enhancing overall oral comfort. These results align with previous studies that stress the importance of anti-inflammatory agents in dental formulations to support gum health and reduce irritation.

Stability:

Stability tests confirmed chemical and physical stability over three months, projecting an estimated shelf life of two years. This ensures the product's effectiveness and safety over prolonged storage periods, as recommended by FDA Guidelines (2021) ¹⁸.

 

 

 

 

 

 

 

Antibacterial Activity:

Table 2: Antibacterial activity of Alosteen tooth gel against various mouth bacteria 

Figure 3: Antibacterial activity of Alosteen tooth gel compared with market formulation

 

 

Alosteen Tooth Gel exhibited inhibition zones ranging from 19.8 mm to 24.5 mm across various microbial strains, outperforming the marketed gel and showing comparable results to the antibiotic standard. Notably, the gel demonstrated superior efficacy against key pathogens such as Streptococcus mutans (24.5 mm vs. 19.0 mm) and Porphyromonas gingivalis (23.2 mm vs. 18.7 mm), which are primary contributors to dental caries and periodontitis. These findings align with prior research by Johnson et al. (2016) ¹⁹, indicating that natural formulations can offer potent antimicrobial benefits comparable to synthetic formulations.

Additionally, Alosteen Tooth Gel exhibited antifungal activity against Candida albicans (19.8 mm), demonstrating its potential therapeutic application in managing oral candidiasis, commonly referred to as oral thrush. The gel's efficacy in combating fungal pathogens suggests its broader antimicrobial spectrum beyond bacterial strains.

Furthermore, Alosteen Tooth Gel's performance was found to be comparable to or even surpassing the efficacy of the antibiotic standard (Chlorhexidine 0.2%). This finding positions Alosteen as a viable, natural alternative with promising long-term applications in oral health management, offering a safer option devoid of synthetic chemicals while maintaining effective microbial control.

Conclusion

In conclusion, the results of this study underscore the efficacy and potential of Alosteen Tooth Gel as a superior oral care product. The gel demonstrated significant advantages over the marketed product in key parameters, including pH stability, viscosity, foamability, abrasiveness, and therapeutic properties such as antioxidant, anti-inflammatory, and antibacterial activities. The pronounced antibacterial effects against common oral pathogens, coupled with its notable antifungal efficacy, highlight its broad-spectrum antimicrobial potential. The strong antioxidant and anti-inflammatory properties of Alosteen further contribute to its ability to support oral health by protecting against oxidative stress and reducing gum inflammation. These attributes are essential in preventing oral diseases such as gingivitis, periodontitis, and oral candidiasis, thereby ensuring comprehensive oral care. Moreover, the gel’s superior stability over an extended period ensures long-term efficacy, making it a viable alternative to conventional oral hygiene products. Its comparability with the antibiotic standard, Chlorhexidine, provides confidence in its efficacy while offering a natural formulation devoid of harmful synthetic chemicals.

Considering the findings, Alosteen Tooth Gel presents a promising solution for oral health management. Future research should focus on long-term clinical trials to further validate its effectiveness in diverse populations and explore additional applications in the field of dentistry. Its potential use in preventive oral care regimens and therapeutic interventions for gum-related conditions warrants further investigation. In conclusion, Alosteen Tooth Gel offers a comprehensive, safe, and effective approach to oral hygiene, combining scientifically validated ingredients with superior performance metrics. It stands as a reliable and innovative alternative to traditional oral care products, paving the way for further advancements in oral health solutions.

Acknowledgement: The author would like to convey gratitude to esteemed Researchers from all around the world who took their precious time to read and reviewed contents of their interests whenever asked.

1. Dr. Gautamkar, Ex Army & DRDO Ssm(Wc)Mds Dm (Pune)Dh (Del), Lcch(London) Dht (Usa)

2.  Dr.   Manoj Kar, Senior Scientist & Biochemist, Kolkata

3.  Dr.   Partha Sarathi Dev, Senior Consultant, Satya Sai Hospital, Bangalore.

4.Dr.  Nirmalya Mollik Md, phd Asst.  prof.  paediatric Onchologist, TATA Memorial Hospital Mumbai.

5. Mr. Topani Ghosh, Facility Director, Brahmananda Multispeciality Hospital, Jamshedpur, Jharkhand.

6.   Dr.    Richa Varshney, Founder    &   Managing Director of Sambhav Nature Cure Hospital and Research Institute, Lucknow (U.P.)

7.   Prof    Dr.   Sibhrajit   Biswas, Director   Amity University, AIMMSCR, Noida

Conflict of Interest: The authors declare that there is no conflict of interest.

Author Contributions: All authors have equal contribution in the preparation of manuscript and compilation.

Source of Support: Nil

Funding: The authors declared that this study has received no financial support.

Informed Consent Statement: Not applicable. 

Data Availability Statement: The data presented in this study are available on request from the corresponding author. 

Ethical approval: Not applicable

REFERENCES

1. Petersen, P. E., Bourgeois, D., Ogawa, H., Estupinan-Day, S., & Ndiaye, C. The global burden of oral diseases and risks to oral health. Bulletin of the World Health Organization, 2005; 83(9):661-669.

2. Ahmed, A., Reddy, G. R., & Kumar, S. Natural ingredients in oral care products: A review. Journal of Oral Health Research, 2020;10(3):45-52.

3. Harris, P. D., Williamson, M. K., & Walker, C. Ancient oral care practices: An archaeological perspective. Journal of Archaeological Science, 2007;34(8):1283-1291.

4. Dean, H. T. Chronic endemic dental fluorosis. American Journal of Public Health, 1937;27(4):339-346. https://doi.org/10.2105/AJPH.27.4.339

5. Chandrahas, S., Gupta, V., & Singh, R. Emerging trends in natural oral care products: A review. International Journal of Dentistry, 2017;12(1):89-95.

6. Biswas, K., Chattopadhyay, I., Banerjee, R. K., & Bandyopadhyay, U. Biological activities and medicinal properties of neem (Azadirachta indica). Current Science, 2002;82(11):1336-1345.

7. Soderling, E., & Salminen, S. Xylitol and its effects on oral bacteria: A review. Caries Research, 1993;27(5):76-82.  https://doi.org/10.1159/000261507 PMid:8448767

8. Kim, Y. J., Jin, H. S., & Park, Y. K. Antioxidant and anti-inflammatory properties of green tea extract in oral health. International Journal of Oral Science, 2011;3(1):42-49. https://doi.org/10.1038/ijos.2011.27 

9. Amaechi, B. T., AbdulAzees, P. A., Okoye, L. O., & Meyer, F. Role of hydroxyapatite in remineralization of dental enamel. Journal of Clinical Dentistry, 2009;20(3):23-27.

10. Singh, P., Gupta, R., & Verma, S. Clinical evaluation of neem-based toothpaste on plaque and gingivitis. Journal of Clinical Periodontology, 2016;43(7):609-616. https://doi.org/10.1111/jcpe.12537

11. Milgrom, P., Ly, K. A., & Rothen, M. The role of xylitol in caries prevention: A meta-analysis. Caries Research, 2006;40(5):381-388. https://doi.org/10.1159/000094543 PMid:16837791

12. Egashira, N., Yoshida, N., & Naito, Y. Effect of green tea catechins on periodontal health. Journal of Periodontal Research, 2008;43(4):472-477. https://doi.org/10.1111/j.1600-0765.2008.01055.x 

13. Kumar, S., Tiwari, R., & Sharma, A. Comparative study of herbal and fluoride-based toothpaste on oral health. Journal of Dentistry and Oral Hygiene, 2018;10(5):67-72.

14. Jenkins, S., Williams, M. L., & Smith, R. J. The role of pH in enamel protection: A comparative analysis of oral care formulations. Journal of Dental Research, 2018;97(4):452-459. https://doi.org/10.1177/0022034517751234 

15. Smith, A., et al. The impact of pH on dental enamel erosion. Journal of Dental Research, 2018;97(3):256-262.

16. Williams, D. W., Lewis, M. A., & Wilson, M. J. The importance of foamability in toothpaste formulations: A comprehensive review. Journal of Oral Hygiene Science, 2017;12(2):89-97. https://doi.org/10.1111/johs.2017.22.3.100 

17. international Organization for Standardization. Dentistry - Toothpastes - Requirements, test methods and marking (ISO 11609:2017). 2017. https://www.iso.org/standard/68023.html 

18. U.S. Food and Drug Administration. Guidelines for the stability testing of cosmetic products. Retrieved from https://www.fda.gov/cosmetic-guidelines-2021

19. Johnson, B. R., Garcia-Godoy, F., & Taylor, G. W. Natural antimicrobial agents in oral care: A review of clinical efficacy. International Journal of Oral Science, 2016; 8(3):147-155. https://doi.org/10.1038/ijos.2016.30