The Izun TM. PeriActive oral rinse: A new solution for the reduction of gingival inflammation. A Breakthrough Treatment for Gingivitis

Transcription

1 The Izun TM PeriActive oral rinse: A new solution for the reduction of gingival inflammation A Breakthrough Treatment for Gingivitis

2 The Izun oral rinse: A new solution for the reduction of gingival inflammation Gingivitis Gingivitis and periodontitis are chronic inflammatory conditions of the oral cavity. Gingivitis is a reversible inflammatory reaction to plaque accumulation on the marginal gingiva, which may develop after several days of inadequate oral hygiene. 1, 2 Periodontitis is a serious condition characterized by bone and periodontal ligament loss which can lead to tooth loss if allowed to go untreated. 1, 2 Gingivitis and chronic periodontitis represent two of the most common periodontal conditions. 2 The Centers for Disease Control and Prevention (CDC) estimate that one in every two American adults has significant periodontal disease. The prevalence increases to over 7% in people aged over 65 years. 3,4 Gingivitis is considered a physiological response to plaque deposition; however, if left untreated, the resulting inflammatory cascade can lead to more serious and destructive periodontal disease such as periodontitis. 1, 2 Periodontal disease is considered to be a chronic inflammatory condition which is associated with the progression of other systemic conditions. Current research suggests that gingival inflammation may be a risk factor for cardiovascular disease and is also associated with adverse pregnancy outcome, respiratory disease, kidney disease and certain cancers. 5,6 There is also a strong association between gingival inflammation and diabetes. A meta-analysis of 18 studies found that people with diabetes have a significantly higher rate of more severe periodontal disease compared with healthy subjects. Despite the increased risk of periodontal disease in people with diabetes, gingival inflammation may also have an effect on the progression of diabetes by aggravating existing cardiovascular risk factors and by influencing glycemic control. A meta-analysis of 1 studies which involved a total of 456 patients reported that periodontal treatment led to a significant reduction of absolute HbA1c in people with type 2 diabetes. 7 Chronic gingival inflammation may have serious implications for systemic health. Therefore it is important to intervene and treat the underlying periodontal disease as early as possible to prevent the progression of inflammation throughout the body (Figure 1). 8 Health Intervention Distant host response: liver (acute-phase response), autoantibody Metastic systemic disease: cardiovascular disease; preterm low birth weight; diabetes; osteoporosis Dental Plaque Gingivitis Local host response: cytokines, antibody Contiguous systemic disease (sinus disease, lung disease) Intervention Periodontitis Figure 1. Hypothesized relationship between gingival inflammation, systemic disease and response to periodontal therapy. 8 Current guidelines for the treatment of gingivitis recommend mechanical removal of plaque (through tooth brushing, flossing, dental scaling and root planing procedures), topical and systemic antimicrobial therapy and chemical removal or inhibition of plaque formation using oral rinses. 5

3 Oral rinses are an integral aspect of periodontal treatment and are particularly useful for patients with severely inflamed gums who are unable to effectively brush due to pain and discomfort. 9 Oral rinses are also particularly effective for people with physical and/or cognitive disabilities, such as the elderly who are at increased risk of periodontal disease. 5 is a unique oral rinse that has been shown to help reduce gingival inflammation, dental plaque formation and gingival bleeding. 5,1,15 This novel, filmforming, alcohol-free oral rinse works together with a combination of three botanical ingredients, Centella asiatica,echinacea purpurea and Sambucus nigra, to provide a significant anti-inflammatory effect, while enhancing natural oral healing. 5,1,11 Reviewing the evidence for A prospective, double-blinded, randomized, placebo-controlled trial investigated the efficacy and safety of oral rinse. During a two-week period, 62 patients were randomized to receive (i) oral rinse, (ii) a cetylpyridinium chloride (CPC) rinse, (iii) an essential oils (EO) rinse or (iv) a water-only preparation taste and color-matched to. Patients were instructed to rinse their mouths with 15mL of the given solution three times a day. Moreover, patients were instructed Change in GI Scores in Experimental Gingivitis GI * Water EO Rinse CPC *p value = Figure 2. Change in GI scores in experimental gingivitis (between baseline and final GI scores). only is the rinse tested that led to a statistically significant reduction in GI after treatment (p=.7). All other tested rinses led to an increase in GI. 5

4 to abstain from any dental hygiene intervention, including tooth brushing, flossing or use of any other oral rinse or breath mints during the trial period. The study demonstrated that oral rinse is an effective anti-inflammatory oral rinse, which showed a statistically significant reduction in each of gingival index (GI) and plaque index (PI). As illustrated below, patients who received oral rinse had the lowest rates of gingival inflammation (Figure 2), plaque accumulation (Figure 3) and bleeding sites (Figure 4). 5 Change in PI Scores in Experimental Gingivitis PI Water EO Rinse CPC.2.1 * *p value =.4 Figure 3. Change in PI scores in experimental gingivitis (between baseline and final PI scores). only is the rinse tested that led to a statistically significant reduction in PI after treatment (p=.4). 5 Another evaluation of this study, looking at the use of mouth rinse in comparison to placebo in 54 patients, confirmed the reduction in gingival inflammation. The alternate evaluation reaffirmed that is a safe and effective anti-inflammatory rinse, which has been proven to decrease the incidence of gingivitis and dental plaque formation and the number of spontaneous bleeding sites in an experimental gingivitis model. 1 Change in Number of Bleeding Sites % increase in bleeding sites Control Control Figure 4. Change in number of bleeding sites in experimental gingivitis (increase in # of bleeding sites after treatment). prevented the increase in bleeding normally seen in patients with gingivitis. 5

5 Another study by Levine et al published in 213 investigated the use of oral rinse in combination with PerioPatch, a patch infused with a botanical mixture similar to that formulated into the oral rinse 13. The study followed 18 patients with gingival recession. Gingival recession is a common problem in the general population that may result from inflammation due to an accumulation of dental plaque biofilm, mechanical trauma and poor oral hygiene. Following treatment involving scaling, root planing and oral hygiene, patients were instructed to use two courses of PerioPatch treatment (3 days each) and use the oral rinse twice daily. The study demonstrated a decrease in gingival recession and gingival index and an increase in gingival thickness (GT) 16. Patients treated with this combination also showed lower rates of inflammation and improved rates of healing. Another head-to-head study of oral rinse and a.12% chlorhexidine oral rinse in the post-operative setting found both rinses to be clinically equivalent in preventing plaque accumulation (Fig. 6);, however, was shown to be more effective in reducing inflammation (Fig. 5). In contrast to chlorhexidine oral rinse, did not cause any staining of the teeth (Fig. 7). 11 GI at implant site.45 Chlorhexidine.4 GI Value ** 2 weeks 4 weeks Figure 5. Change in GI score after 2 weeks and 4 weeks of treatment. At 2 weeks and at 4 weeks the treated group exhibited less inflammation around the implant. Note that the GI value approached zero at four weeks for the cohort. 11 * p value =.4 **Chlorhexidine p value =.4

6 PI of implant PI Value Chlorhexidine Figure 6. Change in PI score after 2 weeks and 4 weeks of treatment..5 2 weeks 4 weeks had equal effectiveness compared to chlorhexidine in the prevention of plaque. 11 Staining at all sites 1.4 Chlorhexidine 1.2 Staining index Figure 7. Change in staining of the teeth after 2 weeks and 4 weeks of treatment..2 2 weeks 4 weeks Use of resulted in dramatically lower staining levels than did use of chlorhexidine. 11 As demonstrated by the studies discussed above, oral rinse has anti-inflammatory properties, which are effective in reducing gingival inflammation. Recent studies suggest that oral rinse may be as effective as traditional oral rinses containing chlorhexidine for controlling plaque and may indeed be more effective in reducing rates of inflammation in the post-operative setting. 5,1,11,16

7 natural technology Izun scientists have designed a unique polymolecular material based on natural plant extracts that is carefully monitored, using chemical analysis and bioassays, from plant harvest to the finished product. Izun products capture the beneficial activity of each component, capitalizing on synergistic interactions that emerge from the unique combination within. Izun products amplify and enhance the body's own potential to reduce inflammation in tissue, while activating and orchestrating the natural healing process. As demonstrated by the range of studies to date, is the treatment of choice in a number of scenarios, including the reduction of gingivitis and gingival recession, and in the post-operative setting. In comparison to conventional oral rinses, oral rinse is the only rinse which has been shown to prevent dental plaque accumulation and gingival inflammation while enhancing natural healing. 5,1,11,16 References 1. Eberhard J, Grote K, Luchtefeld M, Heuer W, Schuett H, Divchev D, et al. Experimental gingivitis induces systemic inflammatory markers in young healthy individuals: a single-subject interventional study. PLoS One. 213;8(2):e Tatakis DN, Kumar PS. Etiology and pathogenesis of periodontal diseases. Dent Clin North Am. 25;49(3): CDC: Half of American adults have periodontal disease. American Academy of Periodontology [Internet]. 214 [cited 214 September 7]. Available from: 4. Eke PI, Dye BA, Wei L, Thornton-Evans GO, Genco RJ. Prevalence of periodontitis in adults in the United States: 29 and 21. J Dent Res. 212;91(1): Samuels N, Grbic J, Saffer A, Wexler I, Williams R. Effect of an herbal mouth rinse in preventing periodontal inflammation in an experimental gingivitis model: a pilot study. Compendium of Continuing Education in Dentistry, AEGIS Communications. 212;33(3). 6. Williams RC, Barnett AH, Claffey N, Davis M, Gadsby R, Kellett M, et al. The potential impact of periodontal disease on general health: a consensus view. Curr Med Res Opin. 28;24(6): Janket SJ, Wightman A, Baird AE, Van Dyke TE, Jones JA. Does periodontal treatment improve glycemic control in diabetic patients? A meta-analysis of intervention studies. J Dent Res. 25;84(12): Panagakos F, Scannapieco F. Periodontal inflammation: from gingivitis to systemic disease? In: Panagakos F and R. Davies, (Eds.), Gingival Diseases - Their Aetiology, Prevention and Treatment p Moran JM. Home-use oral hygiene products: mouthrinses. Periodontol 2. 28;48: Levine W, Samuels N, Williams R. Effect of a botanical mouth rinse on dental plaque formation: a randomized, double-blinded, placebo-controlled trial Journal of Oral Hygiene and Health. 214;2(4): Rosen P, Levine W. A pilot study comparing an alcohol free botanical rinse to chlorhexidine rinse in managing post-surgical inflammation with dental implants. Submitted Woelkart K, Marth E, Suter A, Schoop R, Raggam RB, Koidl C, et al. Bioavailability and pharmacokinetics of Echinacea purpurea preparations and their interaction with the immune system. Int J Clin Pharmacol Ther. 26;44(9): Punturee K, Wild CP, Kasinrerk W, Vinitketkumnuen U. Immunomodulatory activities of Centella asiatica and Rhinacanthus nasutus extracts. Asian Pac J Cancer Prev. 25;6(3): Sharma SM, Anderson M, Schoop SR, Hudson JB. Bactericidal and anti-inflammatory properties of a standardized Echinacea extract (Echinaforce): dual actions against respiratory bacteria. Phytomedicine. 21;17(8-9): Krawitz C, Mraheil MA, Stein M, Imirzalioglu C, Domann E, Pleschka S, et al. Inhibitory activity of a standardized elderberry liquid extract against clinicallyrelevant human respiratory bacterial pathogens and influenza A and B viruses. BMC Complement Altern Med. 211;11: Levine W, Samuels N, Bar Sheshet M, Grbic J. A novel treatment of gingival recession using a botanical topical gingival patch and mouthrinse. The Journal of Contemporary Dental Practice. 213;14(5):

8 A Breakthrough Treatment for Gingivitis Recommended uses for : 1 2 for all patients who have a tendency to gingivitis and/or periodontitis post surgically after implants or periodontal surgery 3 4 post extractions for reduction of inflammation under dentures or around implants