Method of simplified application of a topical dental antiseptic to improve access to dental care

Abstract

The use of PREVORA brand topical dental solution (100 mg / ml chlorhexidine) sold by CHX Technologies, Inc., Toronto, Canada, to treat and / or prevent the advance of both dental decay (caries) and periodontal disease in a simplified method of application in a non-clinical setting. A rapid and simplified treatment with PREVORA comprising the application of PREVORA with a cotton swab, for example, on the surface of the tooth extending down to the gum line was found to produce dramatic reduction in soft tissue inflammation. No cleaning, scaling, or other procedures were required to obtain this effect. Thus, no special equipment or skill is required to administer a PREVORA treatment. This enables a dental professional, medical assistant, nurse, pharmacist, for example, to treat the elderly or disabled where they live. Moreover, the typical chair time for such treatment is 10-15 minutes, or less, and the procedure is pain-free.

Description

[0001] Method of Simplified Application of a Topical Dental Antiseptic to Improve Access to Dental Care

[0002] Relationship to Other Application

[0003] This application claims the benefit of the filing date of United States Provisional Patent Application Serial Number Serial No. 63 / 645,841 filed May 10, 2024, Conf. No. 9878 (Foreign Filing License Granted) in the names of the same inventors as herein. The disclosure in the identified United States Provisional Patent Application is incorporated herein by reference.

[0004] Background of the Invention

[0005] FIELD OF THE INVENTION

[0006] This invention relates generally to a method for treating and / or preventing the advance of dental disease including both major dental diseases, specifically decay (caries) and periodontal disease, and more particularly, to a simplified method for treating and / or preventing the advance of dental disease in a non-clinical, community setting especially for adults with dental fear and anxiety, with difficult tolerating invasive dental procedures or siting in a dental chair for any length of time, or with difficulty getting to and from the dentist.

[0007] DESCRIPTION OF THE PRIOR ART

[0008] The prior art consists of mechanical cleaning and scaling of tooth surfaces above and below the gum line for deposits of calcified bacteria (calculus) and bacterial films which can be pathogenic to either the teeth and / or gums. These procedures are almost exclusively conducted in a dental practice by a hygienist, and require 45 minutes to an hour to accomplish, and requires extensive and expensive equipment to remove deposits and films and to handle aerosols generated during these procedures.

[0009] This standard of preventive care presents barriers to many adults because it is time consuming and thereby costly, can generate discomfort and pain, and can generate fear and anxiety associated with going to the dentist

[0010] As a result, 1 in 3 adults have limited access to dental care. In particular, those without dental insurance, those with a limited ability to sit in the dental chair for any length of time, and those with mental health issues or cognitive limitations have poor access to dental services because of these standards of care. There is, thus, a large and growing unmet need to improve access to dental services by way of changing the approach to dental cleanings and periodontal scaling.

[0011] Dental professionals face difficulties in delivering care outside of the dental practice because their equipment is bulky to transport, and the conventional invasive procedures generate aerosols and cause bacteremia which are unacceptable in a public or non-clinical setting.

[0012] These two realities suggest that a new model of preventive, non-invasive dental care is needed to deliver oral healthcare to the millions of adults in need of such care in non-clinical settings. This new model must reduce chair time, require minimal if any dental equipment, be non-invasive, and be able to serve many patients in a day. And given the huge scale of the access problem, any new model of dental care needs to be able to be conducted by dental professionals working with other healthcare professionals.

[0013] As a result of this unmet need, particularly among the elderly population, three studies were designed and implemented to develop and test a new, suitable and barrier-free model of community-based preventive dental care for high-risk adults.

[0014] The sponsor of these studies, CHX Technologies (hereinafter "CHX") has developed and gained regulatory approval for a high-strength, sustained-release antiseptic dental solution of chlorhexidine (lOOmg / ml chlorhexidine) for prevention of caries in high-risk adults sold under the trademark PREVORA by CHX Technologies, Inc., Toronto, Canada (hereinafter "PREVORA").

[0015] Since 2007, PREVORA (DIN02046245) has been used by Canadian dental professionals to prevent root caries which is common in older adults and which frequently co-exists with periodontal disease. More recently, dentists and hygienist have used PREVORA off-label for the prevention of periodontal disease.

[0016] Periodontal disease and caries result primarily from an imbalance of the microbial composition of the biofilm on the teeth, at the gum line or under the gum line, and has been treated by some progressive members of the dental profession with the application of PREVORA to the teeth, up to an including the gum line, but not under the gum line, following standard oral cleaning and debriding of plaque. See, for example, WO 2020 / 049365 published June 25, 2020.

[0017] However, less progressive members still treat dental decay and periodontal disease by more invasive and laborious dental cleanings and mechanical deep scaling and root planing. This is based on conventional thinking that only the mechanical removal or debridement of plaque from the tooth surface and the subgingival periodontal pockets is effective to treat dental disease. As a result, the efficacy of using a topical solution, basically applied at the gum line, to reduce inflammation which is below the gum line, is not obvious to dental professionals who are experienced in managing such inflammation.

[0018] According to the disclosure of WO 2020 / 049365, the preferred treatment plan involves up to 4 applications of PREVORA to the teeth, up to and including the gum line, of a high risk patient, which might be a patient with Type 2 diabetes or frailty, in the first two months, followed by semi-annual single applications thereafter for as long as the patient remains at risk of caries and / or periodontal disease. Annual risk assessment of poor oral health was suggested for continuation of PREVORA treatment beyond year 1. Excellent results were obtained with this protocol, including a significant increase in the number of healthy periodontal probing sites in patients who had been unresponsive to the conventional standard of hygiene care ( / .e., mechanical deep scaling and root planing) while the number of diseased sites decreased. Meanwhile, only one of 70 patients treated in a similar fashion experienced an increase in caries during the course of applying this formulation.

[0019] Heartened by this success, some Canadian dental hygienists, dentists, doctors, and nurses have been innovating with the delivery of PREVORA to treat patients with type 2 diabetes, dementia, special needs, and muscular disorders which limit oral hygiene. For example, just prior to the COVID pandemic, a pilot study was successfully conducted by a dental hygienist in a family medical practice to treat chronic oral inflammation in type 2 diabetics during their quarterly medical consultation by the application of PREVORA to the patient's teeth up to and including the gum line, following standard oral cleaning and debriding of plaque at or below the gum line.

[0020] However, as discussed above, in the context of providing dental care for the elderly and disabled, the poor and the fearful, conventional cleaning and scaling are invasive, painful, time-consuming, and expensive. There is, therefore, a need for a simpler method of treating dental disease that would be quick, that is, would require little chair time, would be pain free, would be inexpensive, and would be able to be conducted in a non-clinical community setting, such as in nursing homes, senior citizens centers, medical offices, pharmacies, and the like, so that the patient does not have to travel to and from a dental practice.

[0021] Summary of the Invention

[0022] The success of these studies led to the development of what is termed herein as a rapid or simplified non-invasive method for treating and / or preventing the advance of dental disease including caries and periodontal disease in a non-clinical, community setting with the direct application of PREVORA to the teeth, without cleaning or scaling, that is quick, painless, does not generate aerosols or bacteremia, and does not require special skills or equipment.

[0023] As used herein, the term "community setting," includes, without limitation, hospitals, community centers, transition housing, housing for the near-homeless adults, long-term care facilities, senior housing, hair salons, pharmacies, and medical practices. Of course, the method can also be conducted in a dental clinic or practice. However, a significant advantage of this simplified method is the ability to treat patients, particularly in this population pool, where they reside, recreate, and otherwise, have business.

[0024] The rapid procedure of the instant invention involves the direct application of PREVORA to the full dentition, that is to the tooth (crown) surfaces up to and including the gum line, which can be accomplished in about 10 minutes, without a dental cleaning or periodontal scaling. The technique is as simple as painting the PREVORA solution(s) on the teeth with a cotton swab or fine paintbrush. What is unique, and contrary to conventional practice, is that PREVORA is applied to the dentition without any preceding cleaning, scaling, planing, or other dental procedures.

[0025] Periodontal scaling, for example, inherently restricts access to dental care because it is laborious, invasive, can be uncomfortable, generates aerosols, can cause bacteremia, requires frequent repetition, is technique-sensitive and is expensive. By contrast, the simple application of PREVORA in accordance with the present invention is a procedure which removes these barriers. It is non-invasive, requires a fraction of the time, generates no aerosols or bacteremia, and is easy to use by healthcare professionals or others with a minor amount of training.

[0026] The oral cavity of a human patient includes, inter alia, the upper and lower gums and, of course, the teeth which have a crown portion that extends through the gums, or gingiva, thereby creating a gum line. The gum line simply distinguishes the crown (commonly known as the tooth) from the root of the tooth which lies below the gum. There is a space below the gum line which is between the root of a tooth and the surrounding gum tissue, known as the gingival crevice, where periodontal pathogens are known to flourish. However, as will be proven in the three studies presented hereinbelow, it is not necessary to scale or plane below the gum line, or to apply PREVORA under the gum line into the gingival crevice in order to achieve a dramatic reduction in soft tissue inflammation. Chlorhexidine (C22H30CI2N10) is an antiseptic and disinfectant that has bactericidal and bacteriostatic action against a wide range of gram-positive and gram-negative bacteria. We have discovered that PREVORA has the all of the unique features required for the practice and implementation of this invention.

[0027] PREVORA is a solution of 10% (w / v) chlorhexidine, 20% (w / v) compendial-grade Sumatra benzoin, and 70% (w / v) ethanol. When applied as directed by CHX, between about 400 and 600 ml are typically applied to the teeth, thereby depositing about 40 to 60 mg of chlorhexidine in the oral cavity. Advantageously, the PREVORA formulation has a viscosity of about 7 to 17 cP so that, in combination with the high concentration of chlorhexidine in the product, PREVORA is retained on the tooth surfaces for a time sufficient for the chlorhexidine to disrupt the biofilm and delay the re-emergence of dysbiosis thereby effectively treating and preventing the advance of chronic inflammation and bleeding of the periodontal tissues.

[0028] PREVORA comprises two inter-related and sequentially applied coatings sold together as a kit: the first being an antiseptic formulation called Prevora Stage 1 and the second being an inert polymer coating, specifically polymethylmethacrylate, called Prevora Stage 2. Prevora Stage 1 serves to reduce and then inhibit the bacteria causing dysbiosis. Prevora Stage 2 serves to enhance the bonding of Prevora Stage 1 to the tooth surface and to minimize side effects such as a bitter taste or stinging of the oral mucosa associated with the application of a high strength antiseptic called Prevora Stage 1 to the gum line where keystone pathogens for both caries and periodontal disease reside. In vitro and in vivo studies show that the combination of the two coatings, deliver a bactericidal concentration to the biofilm for up to 3 days and an inhibitory concentration for several weeks.

[0029] As used herein, application of PREVORA means the sequential application of both Prevora Stage 1 and Prevora Stage 2 as instructed by the manufacturer. In accordance with the simplified method of the instant invention, this can be accomplished in 10 to 15 minutes, or less.

[0030] In a treatment regimen in accordance with the present invention, the patient is evaluated using standard diagnostic measures, such as bleeding on probing, probing pocket depth, and emergence of cavitated lesions to establish a baseline. Then there are two applications of PREVORA to the teeth, preferably a week apart or within two weeks from the first application, followed by single treatments at month 3 and month 4 from baseline. The patient should then be examined at month 6 for inflammation and dental caries and treated with PREVORA, if warranted, based on standard diagnostic measures. Commonly, no further treatment with PREVORA is required until month 12. Of course, annual check-ups are strongly recommended thereafter.

[0031] Applicant's simplified method of treating teeth in the oral cavity of patients, is particularly useful for patients at risk for either periodontal disease and / or caries, which certainly includes a patient population comprising elderly, physically and / or mentally challenged. However, the method of the invention would have applicability to anyone who has teeth. The ability to provide the service rapidly in a community setting without the need to provide expensive professional dental services, such as mechanical scaling and root planing, makes it particularly beneficial for the economically disadvantaged who lack the resources to obtain professional dental care.

[0032] As used herein, the term "elderly" is defined as older adults, or seniors who are 65 years and older.

[0033] As used herein, the term "at risk" means anyone who has a recent history of caries, specifically existing, ongoing, and / or recurrent, caries, and / or has twenty or more sites of bleeding on probing.

[0034] Detailed Description

[0035] To test the efficacy of this simplified new procedure, three unpublished studies were conducted in the year specified and the results are as summarized in Table 1.

[0036] TABLE 1 All studies showed a dramatic reduction in periodontal disease and professional time for treatment thereof. Moreover, all study participants expressed significant acceptability to the procedure by way of post-treatment questionnaires and by way of continuing on the treatment plan.

[0037] The DiNardo Study

[0038] The original study (Table 1, Study 1) was conducted by the inventor of this patent in her hygiene practice in the belief that a high-strength antiseptic could penetrate the dental biofilm and thus impart some treatment effect. The inventor had episodic experience with this treatment effect of PREVORA using the rapid, non-invasive method in patients with dementia who could not sit in the dental chair for more than a few minutes and thus had to forego cleaning and scaling before the application of PREVORA. These very distracted patients experienced significant benefits in terms of much reduced chronic oral inflammation.

[0039] This study recruited senior citizens who had not visited the dentist on a regular basis because of fear and anxiety and because of cost. The participants had as mean age of 71 and all had extensive periodontal disease at all stages. The hygienist did not clean or scale the teeth but rather simply conducted an oral exam and then applied PREVORA directly to the teeth and gumline. Participants were then invited to return in a week for another exam, and a second application of PREVORA after which they were invited to return in another week for a third and final oral exam. On the third visit, the participants were asked if they would continue with the PREVORA treatment plan. Seven of 10 did continue and 3 submitted written positive testimonials.

[0040] The study results are illustrated in Table 2. The extent of efficacy in this original study surprised the investigator who has more than 35 years of dental hygiene experience and over 10 years' experience with PREVORA. Like her dental colleagues, this inventor was accustomed to conducting a periodontal scaling and / or a dental cleaning for high-risk patients before application of PREVORA. With these results from this first study, supported by the following two studies, the inventor has shortened the time in the dental chair from 45 to 60 minutes, to 15 minutes. TABLE 2

[0041] The Bruvere Healthcare Study

[0042] The Bruyere Healthcare Study (see Table 1, Study 2) was conducted entirely in community settings and institutional settings outside of the dental practice and used both a hygienist and a nurse to conduct the non-invasive direct application of PREVORA to the study participants. This treatment was conducted over 10 weeks and involved 4 applications of PREVORA. A nurse was recruited to apply PREVORA because of a shortage of hygienists in the study area (Ottawa, Ontario).

[0043] This second study recruited seniors with a mean age of 78 years. One in three participants reported regular exhaustion, a reliable sign of frailty, and 14 participants were institutionalized in long-term care and assisted living facilities. About 1 in 5 participants had fewer than 20 natural teeth, the limit for functional dentition and the ability to chew nutritious food. Most participants said they brushed their teeth regularly each day, visited the dentist at least once a year, and had good dental literacy as evaluated by questionnaire at the start of the study. All had moderate to severe stages of periodontal disease.

[0044] This second study was a pilot randomized controlled design using purified water as placebo and used an experienced hygienist to examine participants on a blinded basis at the start and end of study. The hygienist and nurse who applied the study medications without any scaling or cleaning, did so without knowing whether the active or placebo medications were applied.

[0045] The mean tine for treatment in this second study was 10 to 15 minutes, and the medication was applied in a hair salon of a seniors' community center, in a hospital room, and at bedside in institutional settings. No equipment was used other than a mini brush to apply the medication. There were no aerosols or bacteremia, no related safety events, and no drop outs related to the procedure. In a questionnaire, study participants rated this non-invasive rapid dental procedure as being "very important", "very acceptable" and "very worthwhile continuing".

[0046] This second study was terminated before full enrollment to provide data to the Government of Canada on its development of a national dental plan. As a result, the study was under-powered. However, this non-invasive treatment reached clinical and statistical significance in the treated group pre- and post-treatment and had marginal significance (48% reduction of bleeding sites active versus placebo at p=0.056) between active and placebo. There were no differences in clinical treatment results achieved by the hygienist versus the nurse.

[0047] The Toronto Public Health Study

[0048] The Toronto Public Health Study (Table 1, Study 3) continued the evaluation of the direct application method of PREVORA in a high-risk population of low-income seniors receiving public dental care. These seniors have a mean age of 71 years, 60% had extensive dental plaque (which was not removed in this study), half had hypertension and diabetes, and most visited the public dental clinic once a year. Most reported they brushed their teeth at least once a day. The mean number of bleeding sites at the gum line, a gold standard for measuring periodontal disease, was 55 at the start of the study.

[0049] The hygienist applied PREVORA in the same manner as the previous two studies - without any cleaning or scaling, and in a matter of 10 to 15 minutes. Participants received 4 applications over 10 to 12 weeks.

[0050] The study reported the following: a 65% reduction in bleeding sites (p<0.001), a 15% reduction in moderate pocket depth (p<0.001), a very significant treatment effect as measured by Cohen's d of 1.4, and full retention of all study participants. In a questionnaire at the end of the study, participants overwhelmingly rated this rapid, non-invasive procedure as very important, very acceptable, very worthwhile, and very beneficial to general health.

[0051] The method of the present invention, which involves only the direct application of a high-strength antiseptic solution to the teeth and gum line of a high-risk patient using a mini brush or similar applicator, without dental cleaning or periodontal scaling, can be accomplished in a matter of minutes in dental and non-dental settings by a dental or medical professional, or another with a minimal amount of training.

[0052] The method of the present invention offers significant advantages in utility over the existing standard of care with regard to treating periodontal disease and dental caries. Table 3 shows a comparison of the method of the present invention with current standard practice in the dental profession and the advantages of the inventive method.

[0053] TABLE 3

[0054] Although the invention has been described in terms of specific embodiments and applications, persons skilled in the art may, in light of this teaching, generate additional embodiments without exceeding the scope or departing from the spirit of the invention described and claimed herein. While the invention has been described as particularly advantageous for the elderly and disabled, it is to understood that it has applicability to anyone who has teeth. Accordingly, it is to be understood that the drawing and description in this disclosure are proffered to facilitate comprehension of the invention, and should not be construed to limit the scope thereof.

Claims

What is claimed is:

1. A method of treating teeth in the oral cavity of patients at risk for either periodontal disease and / or caries, the oral cavity having gingiva, or gums, and teeth extending through the gums thereby creating a gum line between a crown portion of a tooth and its root under the gums, comprising the step of: applying a topical antiseptic dental solution of chlorhexidine (100 mg / ml chlorhexidine) sold under the trademark PREVORA by CHX Technologies, Inc., Toronto, Canada, to the surface of the teeth of said patients up to and including the gum line in an amount effective to treat and prevent the advance of chronic inflammation and bleeding of the periodontal tissues without any preceding cleaning, scaling, planing, or other dental procedures.

2. The method according to claim 1 wherein the step of applying comprises applying the topical antiseptic dental solution of chlorhexidine (100 mg / ml chlorhexidine) sold under the trademark PREVORA by CHX Technologies, Inc., Toronto, Canada, to the tooth surfaces of said patients with a cotton swab.

3. The method of treating according to claim 1 wherein the amount effective to treat and prevent the advance of chronic inflammation and bleeding of the periodontal tissues is between 40 to 60 mg of chlorhexidine per application.

4. The method according to claim 1 wherein the topical antiseptic dental solution of chlorhexidine has a viscosity of about 7 to 17 cP so that it is retained on the tooth surfaces for a time sufficient to treat and prevent the advance of chronic inflammation and bleeding of the periodontal tissues.

5. The method according to claim 2 wherein the step of applying the topical antiseptic dental solution of chlorhexidine (100 mg / ml chlorhexidine) sold under the trademark PREVORA by CHX Technologies, Inc., Toronto, Canada, comprises sequentially applying an antiseptic formulation called Prevora Stage 1 and then applying an inert polymer coating called Prevora Stage 2.

6. The method according to claim 1 wherein the patients at risk for either periodontal disease and / or caries are a patient population comprising elderly, physically and / or mentally challenged, those with dental fears and anxieties, and economically disadvantaged.

7. The method according to claim 1 wherein the step of applying is conducted in a non-clinical community setting.

8. The method according to claim 1 wherein the step of applying the topical antiseptic dental solution of chlorhexidine (lOOmg / ml chlorhexidine) sold under the trademark PREVORA by CHX Technologies, Inc., Toronto, Canada, to the tooth surfaces of said patients comprises the following treatment regimen: applying a first application of the topical antiseptic dental solution of chlorhexidine; applying a second application of the topical antiseptic dental solution of chlorhexidine within two weeks from the first application; applying a third and fourth application of the topical antiseptic solution of chlorhexidine within three and four months of baseline; and applying subsequent applications of the topical antiseptic solution of chlorhexidine according to clinical need as evaluated using standard diagnostic measures, such as bleeding on probing, probing pocket depth, and emergence of cavitated lesions.

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