Purpose. This study aimed to evaluate reports of patents for oral care formulations, based on Camellia sinensis (C. sinensis), deposited and granted in intellectual property banks. Methods. A survey was conducted through collection, treatment, and analysis of extracted information from patent reports selected. The documentary research was conducted in January 2021 on formulations with C. sinensis for dental applications, including since the first patent deposits until the current time. The risk of bias of clinical trials with these formulations was analyzed to verify the scientific evidence. The data extracted represent the distribution of the number of patents by banks, annual evolution of patent deposits, applicant of patents by country, distribution of patents according to International Patent Classification codes, and the types of patented products. Results. Data and information from 20 selected patents were extracted. The United States Patent and Trademark Office (USPTO) and World Intellectual Property Organization (WIPO) were the banks with the largest number of patents for products/formulations with C. sinensis for oral care applications with 7 (35%) and 6 (30%) patent registrations, respectively. Other banks did not provide patents related to the search. Patents of compositions were the largest with 14 filings, and the remainder of formulations are represented specially by mouthwashes and toothpastes. As for clinical application, 18 patents were filed as products with antimicrobial and antibiofilm action, while 2 patents are directed to the treatment of xerostomia. In general, the aspects of the studies of clinical efficacy pointed to a low risk of bias. Conclusion. The study pointed out a small number of products protected by patents for Camellia sinensis for oral care indication, highlighting mainly mouthwash compositions and formulations. In the methodological parameters of clinical trials carried out with the formulations, the majority pointed out a low risk of bias.
The practice of using medicinal plants with pharmacological activities for the treatment of diseases is ancient, including for conditions related to oral health. The use of natural products as medicinal therapy existed long before the pharmaceutical industry and after the emergence of these products has been incorporated into the development of formulations to the present day [1–3].
Herbs and medicinal plants can be used in different ways, including whole herb, leaves, roots, essential oils, and prepared as teas, syrups, creams, ointments, and even capsules or pills that contain a powdered form of the plant . Tea constitutes an infusion prepared from dry leaves and is the second most consumed drink in the world, its consumption being surpassed only by water, in addition to having great cultural and economic relevance in several countries. Among the most varied types of teas, Camellia sinensis (C. sinensis) teas stand out as one of the most popular and used worldwide [5–7].
C. sinensis is a plant rich in polysaccharides, caffeine, polyphenols, amino acids, and antioxidants, in addition to micro and macronutrients beneficial to human health . It has different important pharmacological properties such as antimicrobial, antioxidant, antidiabetic, and anti-inflammatory activities, in addition to its consumption presenting several documented benefits related to oral health, especially regarding caries and periodontal diseases [3, 6].
This plant is a species belonging to the Theaceae family and has small perennial shrubs, widely used to produce teas, especially green and black . These teas have several pharmacological properties, with their production being carried out mainly in regions of tropical and subtropical climate, with abundant and regular rainfall [9, 10]. According to its fermentation and maturation process, C. sinensis tea can be classified as green, white, yellow, red, and black, where important differences can be verified according to its cultivation and leaf processing [6, 11].
Green tea from C. sinensis has a strong antioxidant power through its polyphenolic chemical constituents, beneficial in several clinical conditions such as dental caries, gingivitis, periodontitis, and halitosis, in addition to neuroprotection in the oral cavity . Since it has a high concentration of fluoride in its nutrient composition, the consumption of this tea is extremely beneficial in repairing dental tissue in an acidic environment and improving resistance to demineralization [12, 13]. Furthermore, it has been shown that this tea has other properties, such as antiviral action against influenza viruses, herpes viruses, and antifungal action against Candida albicans, Trichophyton mentagrophytes, and Trichophyton rubrum .
Black tea is a product of C. sinensis treated with an oxidation process that requires longer steps and contains a greater amount of caffeine when compared to other teas from this plant. Its continued use can reduce blood pressure, the risks of type 2 diabetes, and improve the lipid profile. Its polyphenolic constituents promote health benefits, mainly in obesity, diabetes, cancer, atherosclerosis, inflammatory diseases, and osteoporosis [15–18].
In recent years, the search for new substances and formulations with pharmacological potential and biocompatibility has increased, which is revealed by the growing number of studies on the use of natural products. Often these studies seek to generate new technologies for society with a natural raw material traditionally used, giving rise to the development of innovations and patents [19, 20].
The elaboration of an invention patent or utility model is an extremely relevant indicator to mainly evaluate the level of development and technological innovation in industries and research institutions. Therefore, natural products are sources of biomolecules or therapeutic complexes that can be used for technological innovation and maintain competition in the market in several areas, including products for dental applications [21, 22]. Given the economic importance and medicinal products of C. sinensis, as well as its several benefits to systemic and mainly oral health, this study aimed to evaluate reports of patents deposited and granted on dental formulations based on C. sinensis in intellectual property banks.
2. Materials and Methods
2.1. Elaboration of the Technological Prospective Study
The survey was conducted through collection and analysis of extracted information from patent reports selected. The documentary research was conducted in January 2021 about formulations with C. sinensis for dental applications, including since the first patent deposit in 2004 until all the year of 2020. The searches were direct with access to reports of patents deposited and granted in the following intellectual property banks of worldwide references:(1)Canadian Intellectual Property Office (CIPO)—Canada(2)China National Intellectual Property Administration (CNIPA)—China(3)Espacenet—European Patent Office (EPO)—Europe(4)German Patent and Trademark Office (DPMA)—Germany(5)Intellectual Property India—India(6)Japanese Patent Office (JPO)—Japan(7)National Institute of Intellectual Property (INPI)—Brazil(8)Swiss Federal Institute of Patent Office (IGE-IPI)—Switzerland(9)United States Patent and Trademark Office (USPTO)—United States(10)World Intellectual Property Organization (WIPO)—Europe
2.2. Search Strategy and Data Extraction
For the preparation of the study, we conducted a mapping of patent applications using the keyword “Camellia sinensis” in the search field. All patent documents that included this term were initially considered in the search with the exploratory reading of titles and summaries, as a criterion for inclusion of the patents found. Then, only the active reports related to dentistry were selected; expired, abandoned, or denied patents were not included. Relevant information that describes the invention in the patent reports was selected and organized in graphics in GraphPad Prism 6 program to analyze descriptive statistics.
The data extracted represent the distribution of the number of patents by banks, annual evolution of patent deposits, applicant of patents by country, distribution of patents according to International Patent Classification (IPC) codes, and the types of patented products.
2.3. Scientific Evidence
According to the patents selected at the end of the search, the described inventions and their purposes with dental applications were evaluated and were searched clinical trials related to each selected patent in PubMed.
2.4. Risk of Bias Assessment
Trials were assessed using Cochrane’s tool for assessing the risk of bias in randomized trials . The tool includes the following domains: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, selective reporting, and other sources of bias. We rated each domain as low risk, unclear risk, or high risk of bias.
We classified the overall risk of bias as low if all domains were at low risk of bias, as high if at least one domain was at high risk of bias, or as unclear if at least one domain was at unclear risk of bias, and no domain was at high risk. This rule is specified by the Cochrane tool for assessing the risk of bias in randomized controlled trials because any source of bias in a trial is problematic, and there is a paucity of empirical research to prioritize one domain over the other.
The initial search resulted in 5126 patents found with the term “Camellia sinensis” in the intellectual property banks selected, followed by the stage title and abstract read targeting dental applications from the first patent deposited until the last one that had a total of 28 patent registrations. Then, the repeated records (8) were deleted. At the end of the search, data and information from 20 selected patents were extracted (Table 1).
Oral care composition containing extract of unoxidized Camellia
Oral compositions containing oxidized Camellia
Oral composition comprising Camellia extract of semioxidized tissue from a member of the genus Camellia and an enhancing agent
Composição de higiene oral, método de tratamento ou prevenção de xerostomia e uso de polifenol de chá verde (gtp) (in Portuguese)
Georgia Health Sciences University Research Institute, Inc.
Composição oral, e, métodos para a promoção da saúde oral de um paciente animal, e para a redução da extensão de descoloração em uma pasta de dentes (in Portuguese)
Formulação tópica de uso bucal e seu uso (in Portuguese)
University of São Paulo
Composições odontológicas contendo inibidores de metaloproteinases e seus usos (in Portuguese)
University of São Paulo
Oral care composition
Nippon Zettoc Co., Ltd.
Oral care compositions for treating xerostomia
University of São Paulo
Compositions for the treatment and prevention of infections of the oral cavity
Indena SpA Company
Noncarious material and anticarious agent containing rare sugar
US 20100166678 A1
Matsutani Chemical Industry Co., Ltd./National University Corporation Kagawa University
Antibacterial oral rinse formulation for preventing coronary artery disease
US 20070154414 A1
Richard Paul Bonfiglio
Epigallocatechin-3-gallate crystal compositions
University of South Florida
Oral care compositions containing combinations of antibacterial and host-response modulating agents
US 20070053849 A1
The Procter & Gamble Company
Use of a phenol-containing extract from Camellia sinensisin oral and dental cleaning agents for improving the visual appearance of the gums
Henkel Ag & Co., KGaA
Oral composition containing saponin extracted from the root of Camellia sinensis for effectively preventing or treating periodontal diseases
Jeong Kee Kim; Su Kyung Kim; Dae Bang Seo; Seok Sik Moon
Composition for enhancing oral hygiene comprising natural extract as active ingredient and use thereof
Dongguk University Gyeongju Campus Industry-Academy Cooperation Foundation
Eric M. Sanders
Health care buccal bag for refreshing mouth smell
Foamable mouthwash solid formulation and preparation method therefor
Eun Sang Lee