ORALIA® BLUE PHOTOSENSITIZER

PHOTODYNAMIC THERAPy

Introduction

The antimicrobial Photodynamic Therapy (aPDT) is a non-invasive[1] gentle treatment, where germs are being destroyed with a photosensitizer (dye) - without harming healthy tissue and without systemic side effects.
Indications: periodontal, periimplantitis-caused, endodontic or other superficial inflammations.

Mechanisms of action

Due to its hydrophilia and protonated charge the photosensitizer anneals to the negative carriers of lipopolysaccharides in membranes of gram-negative germs, as well as to the peptidoglycane in membranes of gram-positive germs. When irradiated with an 810nm laser, the dye is being excited to produce reactive oyxgen (singlet / triplet oxygen), which cause harm to the unsaturated fatty acids in the membranes of the germs and their organelles and leads to thier death. Furthermore, the 810nm irradiation, which is not being absorbed in the dye and hits the surrounding tissue, leads to a better wound healing - due to the photobiological effects of LLLT.[1],[2],[11]

For many years already, aPDT has been used in dental medicine.
Especially two photosensitizers, toluidine blue and methylene blue are said to be successfully introduced.[1],[5]

Toluidine blue

Toluidine blue O (TBO) or tolonium chloride, (7-amino-8-methyl- phenothiazin-3-ylidene)- dimethyl-ammonium is a blue cationic (basic) dye used in histology, sometimes clinically. As well as methylene blue, toluidine blue has a slight antiseptic effect. This quite low toxicity means an unproblematic usability for medical applications, especially when used superficially. The LD50 (rat - intraperitoneal injection) is 215 mg·kg-1. After swallowing a fair quantity of toluidine blue, the urine will colour green.[1]

Laser irradiation of toluidine blue

With an absorption maximum of λmax = 635nm toluidine blue is ideally suited for an irradiation with red lasers. When using near infrared irradiation (outside the absorption maxiumum), the absorption is lower, so a part of the irradiation will not be available for excitation. For irradiation with a wavelength of 810 nm it has been shown the needed excitation of the dye takes place when using more laser power, in a way, that the needed energy densitiy and dosis is achieved. Laser irradiation not being absorped in the dye, hits the surrounding tissue and generates additional LLLT effects, especially a better wound healing.[2],[11]

ORALIA® blue Photosensitizer

ORALIA® blue Photosensitizer is a dye on basis of toluidine blue for antimicrobial Photodynamic Therapy for periodontal, periimplantitis-caused, endodontic or other superficial inflammations. Its activation is performed with an 810nm laser device (ora-laser d-lux or its predecessor ora-laser jet).

The dye is being produced in a certain medium-viscosity [not too thin, not too thick], so it provides an optimized flow behaviour (for example in periodontal pockets) on the one hand and and optimized adhesion (superficial disinfections) on the other hand.

Product characteristics and features

  • efficient: selective colouration and destruction of germs
  • well-tolerated: no systemic side effects
  • easy: apply, allow to react, rinse, irradiate [delegable]
  • versatile: to use for periodontics/periimplantitis/endodontics/soft tissue surfaces
  • safe: irradiation through gingiva → no fiber in the pocket, no provocation of bleedings
  • optimized: improved adherence to bone, soft tissue, tooth and root surfaces by a new medium-viscosity

Current data / evidence

Since the early 1990s intensive fundamental research has been performed in the field of bactericidal effekts of aPDT to periodontal pathogens. It is evident, toluidine blue is an effective photosensitizer for destroying both Gram-positive and Gram-negative parodontal pathogens.[8],[9],[10]

Overall, even today, the current data is often described as "expandable", sometimes as "insufficient", but one cannot help but admit, the procedure deserves some attention. The main benefits are: there are no known side effects and only low risks involved and it avoids the problems with buildung up resistance of antibiotics, furthermore it is well controllable and suitable for hard-to-access areas.[1],[5]

In the Conformity Assessment Procedures of ORALIA® blue Photosensitizer is not only been shown, that the minimum stardards are being met (non-toxicity and clinical efficacy) - it has also been shown in a study in 2015 with help of a 3D cell migration test, there are also LLLT- (soft laser)- effects when performing aPDT in combination with ora-laser d-lux. In this study fibroblasts have been placed in a collagen matrix and "treated", whereby the influence of the treatment has been observed (810nm-irradiation, 810nm-irradiation+aPDT and a control group for each) and evaluated. The Study Group found: "We conclude that LLLT as photodynamic therapy (PDT) using ora-laser d-lux 810nm promotes proliferation and maturation of human fibroblasts in vitro.", see study [7].

In a press release from Aug, 17th 2014 we have already reported "biostimulation with low-level laser therapy with a wavelenght of 810nm has been confirmed as a regenerative therapy". Arany et al. have proven in a standardized animal experiment, LLLT activates transforming growth factor-ß [TGF-ß] leading to generation of reactive oxygen and differentiation of autochthonous dental stem cells. [11]

Therefore, they conclude, antimicrobial photodynamic therapy with 810nm laser devices has both an antibacterial and a regenerative effect, which works by the now known pathway of stimulation of transforming growth factor-ß (TGF-ß) directly influencing periodontal stem cells.

Application of the dye + irradiation

A patient information video, explaining the procedure, is available in the database of German "TV-Wartezimmer" [tv-wartezimmer.de].

ORALIA_blue_Photosensitizer_Anwendung.png
Illustrations 1-4: After insertion of dye, irradiate transgingival with 8mm applicator [ill. 1] or internal with fiber-tip [ill. 2-4].

Delegation

One of the applications is the advanced prophylaxis for preservation of the healthy but reduced or beyond-treatment periodontium after periodontitis - here, aPDT can make a major contribution [6]. If needed, the prophylaxis assistant will conduct patient information and application after the doctor's therapy decision. So, the treatment gets more efficient.


Order ORALIA® blue Photosensitizer

Users of ORALIA laser devices

As user of an ora-laser d-lux or ora-laser jet, please request our order form via phone, e-mail or contact form.

Users of other laser devices

If you plan to use ORALIA® blue Photosensitizer with other manufacturers' laser devices, you will first need to check the suitability of this device concerning power, power densitiy, numerical aperture,... - then you will have to show conformity for the application. ORALIA is testing other manufacturers' devices for conformity in an ongoing process. Please get in contact to ask, if your device type has been checked yet.


ORALIA® blue - Supplementary products

The dye is filled in a 10ml primary container/syringe. Herefrom, the needed amount of dye (for example, 0.4 ml for a full-mouth disinfection) is being taken into a smaller secondary container, for example a sterile 2ml single-use syringe. Then, attach a sterile standard single-use blunt cannula and apply to patient.

Sterile single-use syringe (secondary container)

We recommend: B.Braun Injekt® Luer lock, 2ml, single packed, sterile, Luer-Lock, Art.No: 4606701V
You may order these syringes (100 pcs) at ORALIA, see order form.

Pictures: B. Braun Melsungen AG, Melsungen

 

Sterile single-use blunt cannula

We recommend: Transcodent rinsing cannula endo 25G 0,5x42mm, single packed, sterile, Luer lock, Art.No: 6517
You may order these cannulae (100 pcs) at ORALIA, see order form.

Pictures: Transcodent GmbH & Co. KG, Kiel

 


List of references

[1] Hopp/Biffar: "Photodynamische Therapien – Blau versus Grün", erschienen auf zwp-online.info am 05.02.2013

[2] "Wirkung von Softlaser-Strahlung (LLLT) auf Zellen", erschienen auf oralia.com

[3] Liebold/Raff/Wissing: "Kompendium Berechnung von Laserleistungen in der Zahnheilkunde", 2. Auflage, Asgard Verlag, 2015, ISBN: 978-3-537-65501-1, Hier erhältlich: bema-goz.de

[4] Urteil VG Stuttgart [valid for Germany only]

[5] Dr. Steffen Rieger: "Die antimikrobielle photodynamische Therapie in der Parodontologie – aktueller Wissensstand", erschienen auf zmk-aktuell.de am 07.09.2012

[6] Hopp: "Möglichkeiten der Parodontalbehandlung: Teil 5: Nachsorge und Erhaltungsbehandlungen", Dent Implantol 15 (8), 494–505 (2011)

[7] Grimm: "Low-Level Laser Therapy (LLLT) as Photo Dynamic Treatment (PDT) using ora-laser d-lux 810nm Promotes Proliferation and Differentiation of Human Oral Fibroblasts evaluated in vitro"

[8] Chan Y, Lai CH. Bactericidal effects of different laser wavelengths on periodontopathic germs in photodynamic therapy. Lasers in Medical Science 2003;18:51–55.

[9] Sarkar S, Wilson M. Lethal photosensitization of bacteria in subgingival plaque from patients with chronic periodontitis. Journal of Periodontal Research 1993;28:204–210.

[10] Wilson M, Dobson J, Sarkar S. Sensitization of periodontopathogenic bacteria to killing by light from a low-power laser. Oral Microbiology & Immunology 1993;8:182–187.

[11] Arany et al. (2014): "Photoactivation of Endogenous Latent Transforming Growth Factor-ß1 Directs Dental Stem Cell Differentiation for Regeneration", veröffentlicht in der „peer review“ Zeitschrift Sci Transl Med 6, 238ra69

Contact

ORALIA medical GmbH
Schneckenburgstr. 11
78467 Constance
Germany

Tel: +49 7531 284030
Email: info@oralia.com