Actieve zuurstof - Clinical Update 1 Productbeschrijving ‘a donor of oxygen’ Tandpasta of gel met actieve zuurstof draagt bij tot het genezingsproces. De gel en de pasta’s bevatten de gepatenteerde Ardox-X actieve zuurstof formule. De actieve zuurstof gedraagt zich als een zuurstof donor. Eenmaal aangebracht, dringen de zuurstofmoleculen door de huid waarna een geleidelijke zuurstofafgifte plaats vindt. De gels en pasta’s zijn 100% peroxide vrij. De actieve zuurstof technologie is gebaseerd op het hydro-carbon-oxoborate-complex en is geïntroduceerd in 1999 en sindsdien bij vele patiënten toegepast en klinisch onderzocht door Dr. Peter Blijdorp, Kaakchirurg. De gel of pasta gedraagt zich als een actieve donor van zuurstof. Infecties en schimmelvorming krijgen geen kans bij gebruik van actieve zuurstof. Daarnaast is er een specifieke toepassing in de maxifaciale chirurgie en tandheelkunde. Pockets van tanden en implantaten blijven vrij van bacterieen. Pocketvermindering treed direct op. Het doel van de pasta en gel is om tevens alle barrières van wondgenezing op te heffen. De actieve zuurstof wordt toegepast in verschillende vormen, te weten: •
Safe & White, 100 ml, bevat 1 Eq. actieve zuurstof, heeft een naturend blekende werking op de tanden. Verminderd tevens bacterievorming maar in mindere mate dan Implaclean.
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Implaclean, 100 ml, bevat een hoger actieve zuurstof gehalte dan Safe & White, te weten 2 Eq Zuurstof. Omdat Implaclean is ontwikkeld voor patiënten met parodontologische problemen en/of implantaten, bevat deze pasta tevens lactoferrine, een ontstekingsremmend eiwit, Lactoferrine behoort tot het humorale component van het afweermechanisme van het lichaam. Humorale componenten zijn enzymen die zich in het lichaam bevinden die pathogenen remmen, of die andere cellen of enzymen activeren die het pathogeen opruimen. Lactoferrine wordt gewonnen uit koemelk.
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SkinSolv Shampoo, huidcrème, huidbalsem en huidpray, 200 ml, zijn ontwikkeld voor personen met huidproblemen. SkinSolv bevat 1 Eq zuurstof 200 ml en is ontwikkeld voor een schilferige huid en voor psoriasis en eczeem.
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SkinSolv Sport, 200 ml, is ontwikkeld voor sportblessures en bevat 1 Eq actieve zuurstof. De zuurstof dringt door de huid en verlicht de (spier)pijn en stimuleert de helende werking.
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Gel, 2 ml 5 Eq, bevat actieve zuurstof met een hoog beschikbaar gehalte actieve zuurstof (5 Eq) en is ontwikkeld specifiek voor medische indicaties. Toepassing voor wondgenezing of bij implantatie van tandimplantaten en bij brandwonden.
Achtergrond en werking: • Eliminatie van bacterieen en schimmels • Bestrijding van allergien • Promotie van ‘tissue regeneration’ • Voeding van cellen
Indicaties: • Wondgenezing • Chronische infecties • Brandwonden • Eczeem • Psoriasis Werking en Clinical Trials Ardox-X®=HCOB • Chemische formule van het complex van de reactie van een zuurstof donor en diverse dragers
Karakteristieken: • HCOB genereert geen agressieve zuurstof radicalen (O - toxic and damaging DNA) zoas in peroxides, maar is een veilig anionisch actieve zuurstofvorm (O-). • HCOB formule kan, afhankelijk van de toepassing, worden verhoogd in zuurstof concentratie (het laagst is de zuurstof bij Safe & White en Skinsolv en hoogst bij de gel met 5 Eq. • HCOB formules kunnen, afhankelijk van de toepassing, worden aangepast (fast vs slow oxygen release). Wat is Ardox-X® ? • Chemical class:
Hydrocarbon-oxo-borate complex
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Mechanism of action:
Anti-microbial, anti-fungal, increased blood circulation in gum, whitening agent, antiinflammatory, angiogenesis, tissue growth (modulator), anti-histamine
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Pharmacodynamics:
Ardox-X® is embedded in an adjustable slow release matrix which releases its activity at the cellular level
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Route of administration:
Topical, oral
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Formulations:
Cream, gel, foam, rinse, paste, powder, chewing gum (tablets), others under development
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Regulatory:
All ingredients are registered and approved
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Formula based on active oxygen
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The Ardox-X® technology is 100% peroxide-free
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The complex comprises active oxygen, and the Ardox-X® technology makes it possible to stabilize this active oxygen (which is responsible for the whitening effect) within the complex.
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A better performance, without damaging enamel and gums
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Claims are proven by many research reports
Results clinical trials Study location: • Rijnstate Hospital Arnheim, the Netherlands • Dental clinic Venlo, the Netherlands Products: • Implaclean en Ardox-X® gel concentration 5 eq of oxygen • Ardox-X® rinse concentration 2 eq of oxygen Study Active Gel Dr. P.A. Blijdorp, Rijnstate hospital, Arnhem, the Netherlands: i. Case study: To evaluate the efficacy, pocket status, inflammation status, wound healing
Peri-implantitis • 34 patients • 40 implants • Supervised by jaw surgeon Periodontitis • 33 patients • Supervised by mouth hygienist Results: Peri-implantitus:
After 6 weeks: • 34 patients: reduction of the pockkets • 30 patients: bettter wound healing; tight tiissue • 4 patients 2nd treatment After 12 weeks: 30 implants: free of inflammation 9 implants: not cured yet 1 implant: removed After 6 month: 24 patients: bone ingrowths 2 mm 6 patients: bone ingrowths 2 mm 4 patients: no bone ingrowth
Treatment with Ardox-X® guarantees a faster and better woundhealing of the pocket. • 13 man: reduction 66% • 20 female: reduction 49%
Discussion: Periodontitis • Improvement on Chlorohexidine: 4,2% • Improvement on Ardox-X®: 56% • Treatment with Ardox-X® leads to a significant higher pocket reduction Next step: • Double blind placebo controlled trial; Radboud University Nijmegen Post-clinical follow-up and study Ardox-X adjunctive topical oxygen application: Ardox-X® adjunctive topical active oxygen application in periodontitis and peri-implantitis – a pilot study Berendsen JLM1, el Allati I1 , Sylva LH1, Blijdorp PA 2, Van Damme PhA 3, Meijer GJ 4 1. Mondzorgkunde Hogeschool Utrecht, Oral Hygiene Practice C.M.M. Berendsen-Wolters, Venlo, The Netherlands 2. Department of Oral & Maxillofacial Surgery, Rijnstate Hospital Arnhem, The Netherlands 3. Department of Oral & Maxillofacial Surgery, Maas Hospital Pantein Boxmeer, The Netherlands 4. Department of Periodontology & Biomaterials and Oral & Maxillofacial Surgery, Radboud University Nijmegen Medical Centre P.O. Box 9101, 6500 HB Nijmegen, The Netherlands
Abstract Aims: The aim of the study was to gain insight into the healing effects of Ardox-X® in periodontitis and peri-implantitis. Healing is induced through the release of active oxygen in the peridental and peri-implant area. The results were to be compared with the generally accepted ‘gold standard’ - treatment strategies for these disease entities. As reported in the literature, in addition to mechanical/instrumental treatment, antimicrobials such as chlorhexidine digluconate (CHX) and hydrogen peroxide (H2O2) are often prescribed and used in these situations, as well as in many other different oral and dental disorders. These medications are known to have advantageous effects, but they also have their limitations, disadvantages and adverse effects. This pilot study is meant to suggest that Ardox-X® might be a better alternative.
Materials and methods: A case control study in which 33 patients were included, has been carried out to examine the effect of adjunctive treatment with Ardox-X® in periodontitis situations. Full mouth dental pocket depth recordings have been made before and within 3 months after treatment with Ardox-X®. In the peri-implantitis study 34 patients were included, with a total of 40 dental implants. They were all treated according to a standardized Ardox-X® peri-implantitis protocol and were both clinically and radiographically re-examined after 3, 6 weeks and after 3, 6 months, respectively. Results: In the periodontitis study, after 3 months treatment with Ardox-X®, the average total pocket depth decrease was 56%. Different values were scored for male and female patients, 66 and 49%, respectively. Improvement was perceptible in all age categories. The age category of 40-44 years showed the greatest improvement (71%) and the category of 65-69 years the least (36%). There were no remarkable differences in relation to cigarette smoking habits: the average pocket depth decrease in smokers was 56% in patients who had smoked in the past 55%, and in non-smokers 56%. In the peri-implantitis study, the affected tissue had clinically noticeably recovered after 3 and 6 weeks in all cases. After 3 months, 75% of the peri-implantitis situations had been cured (with radiographically definite re-osseointegration in 15% of the implants), 9 periimplantitis had not been cured yet and 1 implant was lost. After 6 months, radiographical examination showed re-osseointegration of 3 mm in 15% of the cases, 2 mm in 60% and no signs of re-osseointegration in 4 cases. Conclusions: From the case control periodontitis study results could be concluded that adjunctive Ardox-X® yielded better average total pocket depht reduction percentages than generally reported in the literature for other treatment strategies. From the Ardox-X® protocol periimplantitis study results could be concluded that the clinical situation around implants improved markedly within 3 to 6 weeks in all cases. After 3 months, 75 % of cases were clinically cured. Radiographically evidenced re-osseointegration of 2 mm could be noted in 60% and of 3 mm in 15% of cases after 6 months. These figures are indicative for faster and better pocket and peri-implantitis healing than reported in the literature for the generally accepted - ‘gold standard’ adjunctive treatment regimens. A prospective double masked placebo controlled split mouth model adjunctive periodontitis treatment study with Ardox-X® is in its final preparation phase.
