A new effective preventive service for your adult patients at high risk of caries

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1 A new effective preventive service for your adult patients at high risk of caries ANTIBACTERIAL TOOTH COATING chlorhexidine diacetate Prevora 100 mg / ml Dental Solution

2 What is PREVORA? PREVORA is the only proven and indicated, in-surgery preventive treatment for coronal and root caries in high risk adults. It is a high-strength, sustained-release chlorhexidine tooth coating which is professionally administered quickly and without pain. PREVORA is designed for use in adults; it is not licensed for use in children. How does PREVORA work? PREVORA stays on the tooth surface for several weeks to inhibit the re-emergence of infection in the dental biofilm. It extends the effectiveness of a prophylaxis for those patients who need additional protection from the accumulation of plaque, which can recur a short time after a visit to the dental surgery 1. How effective is PREVORA? PREVORA is the first, professionally-applied preventive treatment for coronal and root caries in high-risk adults. Four randomised controlled clinical studies, involving over 1,500 patients ranging in age from 11 to 80 years, show that PREVORA s rate of related adverse events is <5% and consists of a short bitter taste and occasional stinging of the oral mucosa. PREVORA is clear on the teeth and leaves no lasting effects on the natural bacterial environment of the mouth. In these studies, PREVORA has also been shown to be highly effective in the prevention of caries at the crown and root in high-risk patients. One placebo-controlled study of older, medication induced xerostomic adults found that PREVORA reduced root caries by 41% (p=0.02) over a period of one year 2. Another adult study found PREVORA reduced coronal caries by up to 60% (p=0.006) in high-risk adults after one year. At this level of prevention, PREVORA is shown to be more effective in adults than fluoride is in children. High-risk patients should also be counselled about limiting their intake of sweet foods and sugary drinks, to enhance PREVORA s protection from adult caries. A magnification of the dental biofilm, which re-emerges to original levels within 2 days of a professional prophylaxis.

3 PREVORA S comparative preventive effects PREVORA vs Fluoride for caries prevention: A comparison of PREVORA controlled studies at p less than 0.05 with published fluoride efficacy data. The results shown are not from a direct comparison. PREVORA is not licensed for use in children. PREVORA S prevention of coronal cavities in high risk adults 41% 60% PREVORA S prevention of all caries in high risk adults 52% PREVORA S prevention of all caries in high risk younger adults PREVORA S prevention of root caries for older xerostomic patients Fluoride varnish* - prevention of children s caries 40% 41% 46% Fluoride mouth rinse - prevention of children cavities Fluoride tooth paste - prevention of children s caries Fluoride gel - prevention of children s caries 24% 22% 26% 0% 10% 20% 30% 40% 50% 60% Prevention of caries vs control (placebo in the case of PREVORA) References: CHX Technologies Limited 2010 Module 5 Clinical Study Report. Anusavice KJ Present and future approaches for the control of caries. J Dent Educ., 69(5): * In a 3 year controlled study 3, PREVORA reduced caries in compliant female adolescents by 31% (p less than 0.05) compared to fluoride varnish. There are no published controlled data reporting significant preventive effects of chlorhexidine rinse or gel in high risk adults. How is PREVORA administered? Follow these simple steps. There is no special equipment needed for the application of PREVORA and training is available from on demand webinars at 1. Assess the patient for risk of caries, then recommend more prevention when required. 2. Take one treatment of PREVORA from refrigeration plus 2 micro-brushes, flour of pumice & isolation rolls. 3. Conduct a prophylaxis of all tooth surfaces with flour of pumice and floss interdentally with un-waxed floss. 4. Isolate the first quadrant using cotton rolls. 5. Apply a thin coating of PREVORA stage 1 to all surfaces in the quadrant, dab PREVORA inter-proximally. Air dry. Then immediately apply PREVORA stage 2 to all tooth surfaces. Then air dry again. 6. Continue steps 4 and 5 in remaining quadrants. On completion of treatment advise patient of post-treatment instructions and book next appointment.

4 Will my older patients pay for more prevention? Case studies of family practices using PREVORA and ongoing patient surveys show that older patients are more receptive to preventive care than any other service you offer 4. The majority of high-risk adults will either pay for PREVORA upon your recommendation or wish to consider this new service at the next appointment 5. Older patients are now more informed about their treatment options than ever before. Half of them know that caries is linked to overall health and that caries is a bacterial infection. Many will ask you about PREVORA when they learn more about this new preventive service from local advertising and articles. Will PREVORA build my practice? Yes, in several ways. This new service meets the needs and preferences of your growing numbers of older, high-risk patients for more preventive care. PREVORA is a new programme of ongoing maintenance care to encourage more regular attendance by your older patients. Your practice will attract new patients when it becomes known as a Partner in Prevention, a network of family dental practices which provides PREVORA to its high-risk adult patients. PREVORA provides your hygiene team with a new service. What is Partners in Prevention? It is a new network of family dental practices, which offer more preventive care to adults in their community. The Partners encourage more risk assessment of adult caries and, in turn more effective preventive care with PREVORA. Until 2012, the Partners in Prevention are practices offering Denplan dental services. Root caries is a more important risk factor for coronary heart disease than cholesterol, a fact which many of your older patients have become aware and are concerned about. ANTIBACTERIAL TOOTH COATING chlorhexidine diacetate Prevora 100 mg / ml Dental Solution

5 1 in 3 older patients have root caries, another is at risk. All 3 prefer more prevention of this chronic disease.

6 Prescribing information Prevora 100 mg / ml Dental Solution Contains chlorhexidine diacetate 100mg Indication Topical treatment for the prevention of coronal and root caries in adult patients at high-risk of dental caries (e.g. xerostomia sufferers or those with 3 or more caries at the start of the treatment plan). Patients should be advised on the importance of oral hygiene and sugar intake. Dosage and Administration Two-stage dental solution and sealant coating applied to the surfaces of the teeth using a brush or cotton pellet. For application only in dental surgeries by dental professionals. Patients receive five treatments in the first twelve months, with treatments 1 to 4 administered weekly over the first month and treatment 5 given at six months. Each treatment is applied to the entire dentition. Individual doses are between 300 µl to 600µl. Additional treatments may be applied as necessary to prevent further dental caries. Contraindications Hypersensitivity to chlorhexidine, Sumatra benzoin or ethanol. Special Warnings & For external (oral) topical use only. Avoid application to the soft tissues. Precautions for Use Use with caution in patients with asthma and eczema. Pregnancy Not recommended during pregnancy or lactation. Undesirable Effects Irritation of the oral mucosa and bitter taste are side effects seen uncommonly ( 1/1,000 to <1/100). Immediate hypersensitivity reactions, transient tooth sensitivity, loss of taste and discoloration of the teeth and silicate or composite reactions are side effects for which the frequency cannot be estimated. Cost 20 per single treatment (6 treatments per box). Marketing Authorisation Holder CHX Technologies Europe Limited Guinness Enterprise Centre Taylor s Lane Dublin 8, Ireland Marketing Authorisation Number PL 30669/0001 Legal Category P Date of Preparation Unique ID number DL 11/101 References 1. Wilson M Microbial inhabitants of humans: their ecology and role in health and disease. Cambridge University Press, Chapter Banting D et al The effectiveness of 10% chlorhexidine varnish treatment on dental caries incidence in adults with dry mouth. Gerodontology, 17: CHX Clinical Study report # Data on file. 4. Tenenbaum HC et al What your older patients want from their dental services. Oral Health Journal, October available at 5. Vernazza C et al How do private patients value prevention in dental primary care. Data on file available upon request from CHX Technologies Europe Ltd. For more information contact or visit T E ukinfo@chxtechnologies.com CHX Technologies Europe Limited Suite 133, 3000 Cathedral Hill, Guildford GU2 7YB

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