Scientific evidence regarding ASEPTIM

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1 Scientific evidence regarding ASEPTIM This document provides: Section 1: Synopsis of the basic principles of the Aseptim technique and supporting literature references Section 2: Details of the component parts of system and their application and safety together with supporting literature references Section 3: Laboratory Studies on the technique on various bacterial species and supporting literature references Section 4: Clinical model investigations based on laboratory evaluations with supporting literature references Section 5: Clinical evaluations and applications with supporting literature references Each section has a brief resume of each article and includes a copy of the article abstract. The full article will be available on disc. Please note that Aseptim is the brand name used by SciCan to market the PAD technology. In all cases, where an article refers to PAD TM (also known as PACT and PDD), please interpret this as Aseptim.

2 Section 1 Synopsis of the basic principles of the Aseptim technique and supporting literature references

3 This section provides a number of articles which describe the use of Aseptim (also known as PAD, PACT and PDD) as a means of killing bacteria. The papers describe the principle behind the process and also the extent to which this type of technology has been developed. The following papers give indications for the use of Aseptim. An editorial from Journal of Photobiology and Photochemistry highlights the factors which influence the outcome and which are important for satisfactory performance.

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6 Wainwright s article in Antimicrobial Chemotherapy 42:13-18 [1998]highlights the potential for PAD [PACT] The article by Konopka and Gosliski entitled Photodynamic Therapy in Dentistry J Dent Res provides a general overview of PDT in dentistry and within this there is a section on the use as an antimicrobial treatment

7 The final article in this section by Jori et al Photodynamic therapy in the treatment of microbial infection :Basic principles and perspective applications Lasers in Surgery and Medicine 38: [2006] is the most comprehensive and gives many of the details which are relevant to the successful application of PAD

8 Section 2 Details of component parts of system and their application and safety Together with supporting literature references

9 The first paper demonstrates the variety of light which have been used to produce the excitation of the photosensitiser. It illustrates the use of not only lights produced by a laser source but alternatives such as Xenon lights. This demonstrates than there is only a need for sufficient delivered energy to produce the excitation The next paper written in 2003 demonstrates that both wavelength and energy density are important factors in producing the PAD effect. AT that point they considered that the most effective way of delivering the light was by the use of a low power laser of optimal wavelength.

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11 A number of extraneous factors can influence the performance of the photosensitiser and the following paper demonstrates that the two common photosensitisers used in dental applications are affected slightly differently by the presences of calcium ions. The action of methylene blue is reduced more in the presence of Ca ++.

12 The paper by Usacheva shows the potential mode of action of the photosensitisers with a range of bacteria and indicates the activity of the photosensitiser with the cell wall

13 Komerick examined the effect of PAD on the oral mucosa of the rat and showed that at Toluidine Blue O mediated PAD had no effect on the normal tissue

14 Section 3 Laboratory studies on the technique on various bacterial species and supporting literature references

15 Zanin [2005] demonstrates that the both LED and HeNe laser light were effective at activating the Toluidine Blue photosensitiser to effectively kill S mutans in biofilms

16 The second paper by Burns et al show that a range of oral bacteria are susceptible to the effect of light and a photosensitiser

17 William s paper shows that the effect of the energy density used has an effect on the reduction in bacterial load increasing with increased energy

18 Bevilacqua s paper demonstrates the effect of LED light and Toluidine Blue O on S mutans viability and shows substantial log reduction in bacterial load

19 Burns et al demonstrate al alternative e laser light source can be as effective provided that the wavelength matches that of the photosensitiser

20 Giroldo s paper demonstrates that the PAD process is effective against C albicans

21 Zanin s 2006 paper shows that bacterial load reduction in biofilms grown on enamel could be achieved with LED light sources and Toluidine Blue O

22 Section 4: Clinical model investigations based on laboratory evaluations and supporting literature references

23 Endodontics

24 In vitro study of PAD showing that PAD may be used as an adjunct to conventional endodontic therapy

25 Laboratory study showing that PAD may be used as an adjunctive therapy to conventional endodontic therapy

26 Further study demonstrating that PAD is effective against E Faecalis and would be suitable as adjunctive therapy in conventional endodontics

27 Laboratory studies showing the PAD would be a suitable technique for use in endodontics having established the operating parameters

28 A further study to demonstrate the effect of PAD on E Faecalis the bacteria normally associated with failed endodontic therapy

29 A study confirming that the parameters for use with PAD need to be defined to produce effective killing

30 Study which defines parameters for effective PAD treatment of root canals and training blocks showing effective bacterial kills

31 Caries

32 Study of a collagen model to demonstrate that lethal photosensitisation of S mutans can be achieved

33 A detailed study to determine the effective parameters for PAD treatment in a caries model

34 A study using LED light source and photosensitiser showing effective killing of bacteria in dentine

35 Periodontology

36 A laboratory study to demonstrate effective PAD in supragingival plaques

37

38 Section 5: Clinical evaluations and applications and supporting literature references

39 In vivo study demonstrating efficacy of PAD technique in endodontics as an adjunct to conventional treatment Bonsor S Nichol R Reid T and Pearson GJ British Dental Journal :

40 An alternative technique for endodontics using PAD technique without other methods of disinfection Bonsor S Nichol R Reid T and Pearson GJ British Dental Journal :

41 Independent study of PAD techniques on deciduous dentition in endodontics

42 Study of the effects of PAD technique in treatment of periodontal lesions

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44 Other uses of the PAD technique

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