Method of Preventing Both Caries and Periodontal Disease Simultaneously in One Procedure

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, simultaneously and in one procedure, that can easily be accomplished by a dental professional or a medical assistant. Chronic periodontitis and/or caries, the result of an imbalance of the microbial composition of the biofilm on the teeth, at the gum line or under the gum line, can be treated by the application of PREVORA, following standard oral cleaning and debriding of plaque at or below the gum line, to restore the balance of the biofilm to more normal, symbiotic composition. This treatment method is particularly useful in conjunction with the medical management of chronic diseases, such as type 2 diabetes, chronic obstructive pulmonary disease, cardiovascular disease, and the like, which have been associated with periodontopathogens. As an example, the topical dental solution is applied to the teeth of an adult diabetic patient every 3 months for the first year, followed by semi-annual single applications for as long as the patient remains at risk for either periodontal disease or caries.

Claims

1. The use of a topical antiseptic dental solution of chlorhexidine (100 mg/ml chlorhexidine) sold under the trademark PREVORA by CHX Technologies, Inc., Toronto, Canada, applied to the tooth surfaces of patients at high risk of either periodontal disease and/or caries up to and including the gum line to treat and prevent inflammation and bleeding of the periodontal tissues simultaneously with the prevention of caries.

2. A method of treating high risk adult patients for both caries and periodontal disease simultaneously comprising the steps of: a) cleaning the teeth; b) debriding plaque at and below the gum line; and c) applying a topical antiseptic solution of chlorhexidine (100 mg/ml chlorhexidine) sold under the trademark PREVORA by CHX Technologies, Inc., Toronto, Canada, to the tooth surfaces of the patient up to and including the gum line.

3. The use of a topical antiseptic solution according to claim 2 wherein the PREVORA brand topical dental solution is applied to said high risk adult patients in a treatment regimen that involves from 1 to 4 applications of PREVORA brand topical dental solution in the first month or two of instituting treatment followed by a single semi-annual application of PREVORA brand topical dental solution for as long as the patient remains at risk for either periodontal disease or caries.

4. The use of a topical antiseptic solution according to claim 3 comprising the step of assessing the risk for either periodontal disease or caries on an annual basis.

5. The method of claim 3 wherein the high risk adult patient has Type 2 Diabetes and the PREVORA brand topical dental solution is applied every 3 months for the first year in conjunction with medical appointments for the management of diabetes, followed by a single semi-annual single application for as long as the patient remains at risk for either periodontal disease or caries.

6. The use of a topical antiseptic solution applied to the tooth surfaces up to and including the gum line to treat and prevent inflammation and bleeding of the periodontal tissues simultaneously with the prevention of caries in the management of chronic disease that are associated with cariogenic and/or periodontopathic microorganisms.

7. The use of a topical antiseptic solution in accordance with claim 6 wherein the chronic disease is selected from the group consisting of Type 2 diabetes, Chronic Obstructive Pulmonary Disease, Cardiovascular Disease, Cerebrovascular Disease (atherosclerosis), Xerostomia (dry mouth); and conditions that cause physical limitations on maintaining good oral hygiene such as cerebrovascular disease (stroke) or Parkinson's Disease.

8. The use of a topical antiseptic solution according to claim 6 wherein the antiseptic solution is PREVORA brand topical dental solution (100 mg/ml chlorhexidine) sold by CHX Technologies, Inc., Toronto, Canada.

9. The use of a topical antiseptic solution according to claim 7 wherein the antiseptic solution is PREVORA brand topical dental solution (100 mg/ml chlorhexidine) sold by CHX Technologies, Inc., Toronto, Canada.

Description

BRIEF DESCRIPTION OF THE DRAWING

[0043] Comprehension of the invention is facilitated by reading the following detailed description, in conjunction with the annexed drawing, in which:

[0044] FIG. 1 is a chart showing the change in probing depth measured over the course of one year for periodontal patients who were unresponsive to root planing and were treated with PREVORA brand topical dental solution (100 mg/ml chlorhexidine) in accordance with the method of the present invention.

DETAILED DESCRIPTION

[0045] PREVORA was approved the regulatory authorities in Canada (DIN02046245), the United Kingdom (PL30669) and Ireland (PA1205), as well as by the European Medicines Agency (EMA/HJA-29/1258) as a professional product for the prevention of caries in high risk adults. These approvals are based on two controlled studies in high risk adults which showed that PREVORA significantly reduced caries over one year compared to placebo. These studies were not designed to elucidate the effect of PREVORA on periodontal disease and, in fact, none of the investigators observed or reported any effects on the periodontal tissues to the study sponsor, CHX Technologies, Inc., during or after completion of these controlled studies. See, Banting, et al, , “The Effectiveness of 10% Chlorhexidine Varnish Treatment on Dental Caries Incidence in Adults with Dry Mouth,” Gerodontology, Vol. 17, No. 2, pages 67-76 (December 2000); and Symington, et al., “Efficacy of a 10% Chlorhexidine Coating to Prevent Caries in At-risk Community-dwelling Adults,” Acta Odontol. Stand., Vol. 72, No. 7, pages 497-501 (October 2014). Therefore, the efficacy of PREVORA in the present invention was unanticipated.

[0046] From 2007 to 2018, PREVORA was only marketed in Canada, and within its approved indication which is for the prevention of root caries, an aggressive and age-associated form of caries whereby the enamel and/or cementum approximate to the cemento-enamel junction and/or the gum line are eroded via dysbiosis to expose the tooth root.

[0047] In 2007, the Province of Ontario, Canada, enabled registered dental hygienists to practice independently of the dentist. In 2013, the College of Dental Hygienists of Ontario further enabled these independent hygiene practitioners to prescribe prescription drugs if such drugs were used by the hygienist during the visit of a patient. These new laws and regulations in Ontario have restructured the conventional organization of the dental practice which was described above. The separation of professional focus on caries versus periodontal disease has become blurred in the practice of the independent hygienist. In this circumstance, the dental professional became responsible for both caries and periodontal prevention—in other words, for the whole mouth of the patient.

[0048] In 2013, one independent hygienist in Hamilton, Ontario, began to use PREVORA on patients at high risk of root caries, with the intent of using the product to prevent root caries only, as per the therapeutic indication of this drug.

[0049] This hygienist subsequently and unexpectedly observed that PREVORA markedly improved the health of inflamed and bleeding gums, an indicator of periodontal disease, when applied up to and including the gum line, as per the directions of use for caries prevention. Commonly, these patients showed marked rapid periodontal improvement within 4 weeks of the first application of PREVORA to the tooth surfaces despite the fact that PREVORA was not directly applied to periodontal tissue.

[0050] Subsequently, up to mid-2018, this same hygienist applied PREVORA to as many as 70 other adult patients with similar and consistent effect on the periodontal tissues. Most particularly, this hygienist observed a statistically significant treatment effect over one year, on the periodontal health of 8 patients who were unresponsive to the standard of hygiene care for periodontal disease—mechanical deep scaling, also referred to as scaling and root planning (“SRP”),

[0051] Refer to FIG. 1. Over 12 months and 5 applications administered once a week for 4 weeks, or once every 2 weeks for 8 weeks in the case of the initial four applications, followed by one single application at month 6 from the start of the treatment plan of PREVORA, the number of healthy periodontal probing sites in these unresponsive patients increased from 829 to 963 while the number of diseased sites decreased from 77 to 12.

[0052] Importantly for this discovery, only one of the 70 other patients treated in a similar fashion experienced an increase in caries during the course of applying this formulation confirming further the anticariogenic effects of PREVORA as compared to the adults experiencing both periodontal disease and root caries as reported by Ravald, et al., supra, and Reiker, et al., supra.

[0053] In view of the foregoing, it is clear that both major oral diseases have been prevented with one treatment procedure and treatment plan. As used herein, the term “simultaneously” refers to treating dysbiosis, both above, below, and at the gum line, in a manner that is capable of impacting impacts oral health, that is both periodontal disease and/or caries (particularly root caries), with one procedure that is administered to the tooth surface up to and including the gum line.

[0054] The preferred treatment plan for the simultaneous treatment and prevention of caries and periodontal disease in high risk adult patients involves up to 4 applications of PREVORA to the teeth of the patient up to and including the gum line, in the first month or two months, followed by semi-annual single applications thereafter for as long as the patient remains at risk of either disease. For adults with Type 2 diabetes who visit the physician every 3 months or so, the PREVORA treatment plan may be dovetailed with these quarterly visits in the first year. Continuation of PREVORA treatment beyond, year 1 should be accompanied by an annual risk assessment of poor oral health (defined herein as the occurrence of either caries or periodontal disease or both) involving the patient.

[0055] Since 2017, this same treatment effect on periodontal tissues has been independently and consistently observed and reported by the dental department of Mount Sinai Hospital of Toronto, Ontario with regard to adult patients with Special Needs and Complex Needs as defined as those with developmental disabilities or adults with multiple chronic diseases necessitating oral health services be conducted in a hospital setting.

[0056] The proof of caries prevention is evident from two randomized controlled clinical trials which are accepted by the following regulatory authorities in issuing drug approval of the use of PREVORA for treating dental caries: Heath Canada, the UK Medical and Healthcare Products Regulatory Agency, the Irish Health Products Regulatory Agency and the European Medicines Agency. The chart on FIG. 1 shows proof of the treatment and prevention of periodontal disease by the application of PREVORA up to and including the gum line.

[0057] No other dental product has shown the ability to manage both caries and periodontal disease simultaneously. The application of an antiseptic to the gum line so as to reduce inflammation which is below the gum line is not obvious to dental professionals who are experienced in managing such inflammation.

[0058] The use of PREVORA according to the method of this invention is advantageous to both the dental professional and the patient. Adult patients benefit from prevention of both major diseases simultaneously from the same procedure This improves the cost-effectiveness and convenience of dental services for the patient. Hygienists benefit from an expanded ability to manage both major diseases simultaneously, and are thereby able to improve their productivity and serve more patients per unit of time. This is particularly relevant to independent hygienists and dental therapists who are increasingly enabled by legislators to practice independently in Canada, the United Kingdom and the United States. Additionally, the invention minimizes the product inventory requirements and associated equipment for performing the management of caries and periodontal disease, for the dental professional. No longer is an array of products needed for the prevention of caries and, separately, for the prevention of periodontal disease.

[0059] Advantageously, the application of Prevora Stage 1 and Stage 2 requires only a small compressor and connected hand syringe to clear the teeth and gingival crevice, and to dry the teeth prior to the application of PREVORA. PREVORA is applied with a mini-brush common to dental hygiene practices, with separate brushes being used for the application of Prevora Stage 1 and Prevora Stage 2. This equipment set up is suitable for venues such as the medical examination room, the wellness center in retirement residences and the consultation rooms in pharmacies

[0060] 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. 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.