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​Studii clinice

Complete Bibliographic Citation Summary of HYBENX® Oral Tissue Decontaminant published literature (21 June 2018).
bibliographyhybenx®productsrev_21june18-1.docx
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Topical Desiccant Agent in Association with Manual Debridement in the Initial Treatment of Peri-implant mucositis: a Clinical Prospective Study. EuroPerio9 (Poster, June 20-23 2018, Amsterdam).G Lombardo, C Signoretto, A Pardo, G Corrocher, J Pighi, A Signoriello, and PF Nocini.
hbx-vs.-chx_lombardo-ep-poster20june18.pdf
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The effects of a desiccant agent in the treatment of chronic periodontitis: a randomized, controlled clinical trial. J Clin Oral Invest. 17 June 2017 (doi:10.1007/s00784-017-2154-7).G Isola, G Matarese, RC Williams, VI Siciliano, A Alibrandi, G Cordasco, and L Ramaglia.
Authors conclude that SRP plus the desiccant (HYBENX® Oral Tissue Decontaminant) resulted in a greater reduction in clinical, microbial and inflammatory mediators compared to SRP alone. HYBENX, when combined with SRP, was demonstrated as a significant approach to control the levels of certain periodontal pathogens and inflammatory mediators in patients with CP for the one-year duration of the study.
isola-et-al-2017.pdf
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Follow up review of the Isola paper in JADA by Romina Brignardello-Petersen, DDS,MSc, PhD:
jada-review-isola.pdf
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The Treatment of Peri-Implant Diseases: A New Approach Using HYBENX® as a Decontaminant for Implant Surface and Oral Tissues. ORAL & Implantology 9(3):106-114. 2016.MA Lopez, M Andreasi Bassi, L Confalone, F Silvestre, and C Arcuri.     
Authors conclude that the use of HYBENX significantly reduced: 1) the need for invasive surgery, 2) bacterial load, 3) patient discomfort, 4) healing time, and, 5) the need for antibiotics, yielding a clear clinical improvement in both mucositis and severe peri-implantitis.
lopez-et-al-no-wm.pdf
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Procedimiento de decontaminación del biofilm para el tratamiento del absceso periodontal agudo y la periimplantitis. [TRANS: The biofilm decontamination approach for treatment of periodontal abscess and peri-implantitis]. Rev Asoc Odontol Argent 104(2): 79-85. 2016.EA Mancini and GP Pini Prato.
Authors conclude that the biofilm desiccation approach seems to be a very promising technique for the treatment of acute periodontal abscess and peri-implantitis without the use of systemic or local antibiotics.
procedimiento-de-decontaminacion-....pdf
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traducción-the-biofilm-decontamination-approachenglish_trans..pdf
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​Nonsurgical Treatment of Peri-implantitis Using the Biofilm Decontamination Approach:  A Case Report Study. Int J Periodontics Restorative Dent. 36(3): 383-391. 2016.GP Pini-Prato, C Magnani, and R Rotundo.
Authors conclude that the biofilm decontamination approach using HYBENX® Oral Tissue Decontaminant is a very promising technique for the treatment of acute periodontal abcesses and avoids the use of systemic or local antibiotics.
ijprd_36_3_11_peri-implantitis.pdf
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Treatment of Acute Periodontal Abscesses Using the Biofilm Decontamination Approach. A Case Report Study. Int J Periodontics Restorative Dent. 36(1): 55-63. 2016.GP Pini-Prato, C Magnani, and R Rotundo.
Authors conclude that the biofilm decontamination approach using HYBENX® Oral Tissue Decontaminant is a very promising technique for the treatment of acute periodontal abscesses and avoids the use of systemic or local antibiotics.
pini-prato-etal_ijprd_36_1_9.pdf
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Actividad Antimicrobiana De Los Compuestos Fenólicos Sulfonados En El Sistema De Conductos Radiculares. Revisión Sistemática. (English Translation: Antimicrobial Activity of Sulfonated Phenolics Components in The Root Canal System. Systematic Review). Rev. Ciencia y Salud Virtual 7(2): 53-60. 2015.K  Abud-Blanco, L Bustos-Blanco, E Covo-Morales, and LC Fang-Mercado.
The authors review the use of sulfonated phenolics in Dentistry and their value in controlling the microorganisms found in root canals in vitro.
abud-blanco-copy.pdf
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A Topical Desiccant Agent in Association with Ultrasonic Debridement in the Initial Treatment of Chronic Periodontitis: a Clinical and Microbiological Study. New Microbiologica 38: 393-407. 2015.G Lombardo, C Signoretto, G Corrocher, A Pardo, J Pighi, A Rovera, F Caccuri, and PF Nocini.
The authors concluded from this 3-month, split-mouth, single-blind, prospective study that greater reductions in  inflammatory parameters and anaerobic bacterial load may be provided when a topical desiccant liquid (HYBENX® Oral Tissue Decontaminant) is used as an adjunct to ultrasonic debridement compared to ultrasonic debridement alone.
giorgio_epub_new_microbiologica2.pdf
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The Efficacy of HYBENX® Oral Tissue Decontaminant for Periodontal Disease Treatment: A Case Series Study. International Journal Of Advances In Case Reports, 2(7):405-408. 2015.D Lauritano, A Girardi and F Carinci.
Authors conclude that HYBENX® Oral Tissue Decontaminant is an efficacious medical device for use in the management of moderate to severe chronic periodontitis.
view-article2.pdf
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​Decontamination Using a Desiccant with Air Powder Abrasion Followed by Biphasic Calcium Sulfate Grafting: A New Treatment for Peri-Implantitis. Case Reports in Dentistry, Volume 2015, Article ID 474839.G Lombardo, G Corrocher, A Rovera, J Pighi, M Marincola, J Lehrberg, and PF Nocini.
Authors conclude that the use of HYBENX® Oral Tissue Decontaminant and air powder abrasives, followed by bone defect grafting, represents a viable option in the treatment of peri-implantitis.
view-article5.pdf
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​Antimicrobial Effects of a Root Canal Cleanser in Treating Contaminated Implants. Ex Vivo Study. IADR Poster Session. Boston. 2015.Z Rifkin, E Lavere, L Mikulski, and S Andreana
The authors conclude that the use of the root canal cleanser (HYBENX® Oral Tissue Decontaminant) was significantly effective at suppressing the growth of S. sanguinis when samples were compared to the control group. Further, this technique can serve as a beneficial form of treatment against peri-implantitis and subsequent infected implant defects not only due to its efficacy in halting bacterial growth, but as well as its non-invasive capabilities during application.
view-article1.ppt
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​Single Application of a Desiccating Agent in the Treatment of Recurrent Aphthous Stomatitis.  Journal of Biological Regulators and Homeostatic Agents 29, no. 3(S1), 59-66. 2015.D Lauritano, M Petruzzi, GM Nardi, F Carinci, G Minervini, D Di Stasio, and A Lucchese.
The authors conclude that a single application of HYBENX® Solution could be a valid support in the management of recurrent aphthous stomatitis.
single-application-of-a-dessicating-agent-in-the-treatment-of.pdf
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​An Alternative Approach for the Treatment of Major Aphthosis: Case Report. J Interdisciplinary Medicine and Dental Science, 2(5): 3pp. 2014.GM Nardi, FR Grassi, D Lauritano, and M Petruzzi.
Authors conclude that the topical application of Oralmedic® Barrier Solution (HYBENX® Oral Tissue Decontaminant) results in an improvement in pain, discomfort, and healing of the aphthous ulcer.
view-article4.pdf
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​A better way to remove the disease-causing Periodontal and Peri-implant Oral Biofilm. Dental Tribune 3(9): 10-13 (in Spanish). 2014.C Argüello
Author summarizes the history, etiology, and health ramifications of oral biofilm. She explains the HYBENX® Oral Tissue Decontaminant technology and recommends that the product be used adjunctively by the dental clinician to improve therapy for periodontal disease and peri-implantitis.
view-article6.pdf
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​Management of biofilm control in an elderly patient suffering from rheumatoid arthritis: a case report. International Journal of Immunopathology and Pharmacology 26(4): 973-6. 2013.GM Nardi, S Sabatini, D Lauritano, C Denisi, and FR Grassi. 
Authors conclude that the use of HYBENX® Oral Tissue Decontaminant, as an adjunct during remediation of periodontal disease, greatly facilitated ease of cleaning and patient comfort.
view-pending-publication-proof.pdf
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Effectiveness of a chemical decontaminant (HYBENX® Oral Tissue Decontaminant) in the reduction of bleeding at hypersensitivity and in improving patient comfort. Poster Presentation at the National Congress of the Faculty of Dentistry, University of Rome, April 18-20. (Translated from the original Italian text). 2013.GM Nardi, S Sabatini, and FR Grassi. 
Authors conclude that bleeding on probing and dentinal hypersensitivity were improved in the treated cohort. Periodontal probing depth and plaque indices were also improved but did not reach statistical significance under the conditions evaluated. Patients preferred the treatment protocol versus the control (no decontamination treatment)
​Full-mouth ultrasonic debridement in combination with HYBENX® Oral Tissue Decontaminant as an initial approach to the treatment of chronic periodontitis. (Translation from the original Italian Manuscript). Quintessence International 28(3): 5-14. 2012.G Lombardo, A Pardo, A Fiorino, G Corrocher, and G Urbani.
The authors conclude that the product can be considered as a valuable aid in the initial treatment of chronic periodontitis.
view-translated-abstract.pdf
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​A clinical practice observation of the effects of HYBENX® Oral Tissue Decontaminant plus instrumentation on non-responding periodontal sites by dental hygienists in the European Union. Hygiene and Prevention: Profile in Oral Health, October: 122. Dentaltown.com. 2011.TE. O’Hehir. 
Pilot clinical trial evaluation of patients in England, Scotland, and Italy using HYBENX® Oral Tissue Decontaminant as an adjuvant in scaling and root planning. Author concluded that HYBENX® Solution treatment reduced pocket depth in 10 of 13 patients with non-responding pockets greater than 5mm at the six week follow-up analysis.
view-article9.pdf
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Randomized controlled trial of the efficacy of HYBENX in the symptomatic treatment of recurrent aphthous stomatitis. J. Oral Diseases 15, 155–161. 2009.SR Porter, K Al-Johani, S Fedele, and DR Moles
Prospective randomized controlled trial evaluated HYBENX® Oral Tissue Decontaminant vs. an occlusive covering device in the treatment of recurrent aphthous stomatitis (RAS). The authors conclude that HYBENX treatment safely and conveniently reduces the pain of RAS.
view-article8.pdf
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Selected Basic Research and Technical Papers   Assessing the Dynamic Biofilm Removal of Sulfonated Phenolics using CP-OCT. Lasers in Dentistry XXIII, P Rechmann and D Fried, Eds. Proc SPIE. 10044: 1004409-7. 2017. K England, J Nikrad, and R Jones.
The authors capture the disruption of multi-species oral biofilms adhering to tooth-like surfaces by HYBENX® Oral Tissue Decontaminant solution using dynamic imaging via a novel CP-OCT near-infrared flow cell assay.
r-jones-2017.pdf
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A Histological Assessment of a HYBENX® Oral Tissue Decontaminant in Vital Pulp Therapy in Dogs. J. Biological Regulators and Homeostatic Agents. Vol. 30, No. 2 (S1), 189-197. 2016.MD Rohrer, HS Prasad, and EG Savord.
The authors demonstrate that the use of HYBENX® Oral Tissue Decontaminant (“HOTD”) compared favorably to the conventional standard of care {Ca(OH)2} in restoring dentin and tooth vitality after vital pulp exposures with significant early stage advantages.
rohrer-et-al-dog-histo-study-color-edit.pdf
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​Exploring Mechanisms of Biofilm Removal. Dentistry 6(4): 371. 2016.
K Sahni, F Khashai, A Forghany, T. Krasieva, and P Wilder-Smith
This study, on the biofilm of extracted teeth, demonstrated that HYBENX disrupts dental biofilm when followed by rinsing.
petra_exploring-mechanisms-of-biofilm-removal.pdf
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Pilot Evaluation of a Simple Adjunctive Method for Improved Removal of Oral Biofilm During Conventional Scaling and Root Planing Therapy. J. Biological Regulators and Homeostatic Agents. Vol.29, no. 3(S1), 6-9. 2015.
J Bracke, M Basara, E Savord, A Dunaway, and M Watkins.
The authors document an unprecedented level of complete molecular debridement of periodontal lesions with the adjunctive use of HYBENX® Oral Tissue Decontaminant during conventional scaling and root planing using DNA pyrosequencing and immunoassay of four inflammatory mediator markers.

pilot-evaluation-of-a-simple-adjunctive-method-for-improved.pdf
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​Safety Data Sheet for HYBENX® Oral Tissue Decontaminant Products
fm-133-e-sds-hybenx-otd.pdf
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Copyright © 2019 EPIEN Medical, Inc
EPIEN Medical, Inc. (Headquarters)
4225 White Bear Parkway
Suite 600
Saint Paul, MN 55110-3389 USA
Telephone: +1.651.653.3380
Contact US Headquarters
LocaGold s.r.l.
via Copernico ,27, 1 - 37135 Verona
Tel. +045/8250391
Contact European Headquarters
HYBENX® Oral Tissue Decontaminant is approved as a Class 1 medical device in the European Union and Canada. HYBENX® Oral Tissue Decontaminant is available to dental professionals as an adjunctive focal irrigant intended for the removal of dental plaque biofilm.
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