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 PADTM (also known as PACT and PDD), please interpret this as Aseptim.

Section 1

Synopsis of the basic principles of the Aseptim technique and supporting literature references

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.

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 86 694-707 2007 provides a general overview of PDT in dentistry and within

this there is a section on the use as an antimicrobial treatment

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 38:468-481 [2006] is the most comprehensive and gives many of the

details which are relevant to the successful application of PAD™

Section 2

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

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.

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++ .

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

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

Section 3

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

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

The second paper by Burns et al show that a range of oral bacteria are susceptible to the

effect of light and a photosensitiser

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

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

Burns et al demonstrate al alternative e laser light source can be as effective provided

that the wavelength matches that of the photosensitiser

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

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

Section 4:

Clinical model investigations based on laboratory evaluations and supporting literature references

Endodontics

In vitro study of PAD™ showing that PAD may be used as an adjunct to conventional

endodontic therapy

Laboratory study showing that PAD™ may be used as an adjunctive therapy to

conventional endodontic therapy

Further study demonstrating that PAD™ is effective against E Faecalis and would be

suitable as adjunctive therapy in conventional endodontics

Laboratory studies showing the PAD™ would be a suitable technique for use in

endodontics having established the operating parameters

A further study to demonstrate the effect of PAD™ on E Faecalis the bacteria normally

associated with failed endodontic therapy

A study confirming that the parameters for use with PAD™ need to be defined to

produce effective killing

Study which defines parameters for effective PAD™ treatment of root canals and

training blocks showing effective bacterial kills

Caries

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

be achieved

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

model

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

in dentine

Periodontology

A laboratory study to demonstrate effective PAD™ in supragingival plaques

Section 5:

Clinical evaluations and applications and supporting literature references

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 2006 200:337-340

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 2006 201:101-105

Independent study of PAD ™ techniques on deciduous dentition in endodontics

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

Other uses of the PAD™ technique