Revolutionary Teeth Whitening Solution · effective teeth whitening BrightTonix Medical td....

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1 Revolutionary Teeth Whitening Solution WHITE PAPER Helping dental professionals provide quicker and safer teeth whitening A new Peroxide-free treatment approach: Y10 by BrightTonix Medical

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    Revolutionary Teeth Whitening Solution

    WHITE PAPER

    Helping dental professionals provide quicker and safer teeth whitening

    A new Peroxide-free treatment approach: Y10 by BrightTonix Medical

  • Introduction

    Peroxide-based treatments are time-consuming

    Concerns with peroxide safety and side effects

    2 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    Personal appearance is important in today’s society. Dentists are called upon to respond to requests from patients who wish to enhance their smiles.1 A common approach to achieving this goal is through tooth bleaching. The International Organization for Standardization (ISO) defines tooth bleaching as ‘removal of intrinsic or acquired discolorations of natural teeth through the use of chemicals, sometimes in combination with the application of auxiliary means.2

    Active ingredients currently used in office and home teeth bleaching are almost exclusively hydrogen peroxide and carbamide peroxide.3,4,5 These office treatments are time-consuming – often requiring treatment preparation and can last over one hour. Furthermore, patients are required to do inconvenient follow-up bleaching at home that is expensive and takes time.

    For many years, the safety profile of peroxide-based materials, widely used in industrial bleaches, has caused controversy and concern, especially in the at-home setting.6 The primary source of these tooth bleaching safety concerns have originated from hydrogen peroxide’s capability to produce free radicals, which attack the organic molecules responsible for tooth discolouration. Studies indicate that oxidative reactions of free radicals with proteins, lipids and nucleic acids, could cause potential pathological damage, that may be associated with ageing, stroke and other degenerative diseases.7, 8,9 These oxidative reactions and

    1 Philip, D.S.: Incorporating cosmetic dentistry into a general practice. J Can Dent Assoc 60: pp. 682–686, 1994

    2 International Organization for Standardization. Dentistry‑ Products for External Tooth Bleaching. ISO 28399:2011 Geneva: ISO, 2011.

    3 Li Y. Biological properties of peroxide‑containing tooth whiteners. Food Chem Toxicol 1996; 34: 887–904.

    4 Kihn P W. Vital tooth whitening. Dent Clin N Am 2007; 51: 319–331.

    5 Li Y. Safety controversies in tooth bleaching. Dent Clin N Am 2011; 55: 255–263.

    6 Li Y, Greenwall L. Safety issues of tooth whitening using peroxide‑based materials. British Dental Journal 2013: 215 (1): 29‑34.

    7 Harman D. The aging process. Proc Natl Acad Sci U S A 1981; 78: 7124–7128.

    8 Lutz W K. Endogenous genotoxic agents and processes as a basis of spontaneous carcinogenesis. Mutation Res 1990; 238: 287–295.a

    9 Floyd R A. Role of oxygen free radicals in carcinogenesis and brain ischemia. FASEB J1990; 4: 2587–2597.

  • Introducing Y10: Faster, safer and effective teeth whitening

    3 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    subsequent damage in cells by free radicals that are thought to be the mechanisms of action responsible for its observed side effects.

    Peroxide-based materials, when applied appropriately and with dental supervision, are in-fact mainly associated with mild-to-moderate side effects including tooth sensitivity, gingival irritation and potential adverse effects on enamel and restorative materials.10, 11, 12, 13, 14, 15 It is the long-term, unknown adverse effects on hard and soft tissues that gives concern. Particularly exacerbated by the inappropriate application or potential abuse by patients in the home setting which may lead to irreversible tooth damage and burns.16

    Dental professionals need safer and more reliable treatments both in the office and during home follow-up that enables faster patient throughput at lower cost, whilst satisfying patients teeth whitening needs.

    Designed with and for dental professionals, BrightTonix’s Y10 innovative tooth whitening system delivers on this promise. Teeth whitening is achieved in as little as one 15 minute treatment session with no prior whitening procedure or refrigeration needed, saving valuable clinical time. Most importantly, Y10 eliminates the need for home follow-up treatment, enabling safer and more reliable teeth whitening. Furthermore, as Y10 provides a peroxide-free treatment approach, the associated side effects of teeth sensitivity and gum soreness are prevented. To date, patients have reported no side effects of any kind during trials.17

    BrightTonix aims to set a new standard in teeth whitening by using friendly, non-abrasive and peroxide-free ingredients. Based on recent

    10 Li Y. Toxicological considerations of tooth bleaching using peroxide‑containing agents. J Am Dent Assoc 1997; 128: 31S‑36S.

    11 Li Y. Peroxide‑containing tooth whiteners: an update on safety. Compend Contin Educ Dent 2000; 21(Suppl 28): S4–S9.

    12 Li Y. The safety of peroxide‑containing at‑home tooth whiteners. Compend Contin Educ Dent 2003; 24: 384–389.

    13 Haywood V B, Heymann H O. Nightguard vital bleaching: how safe is it? Quintessence Int 1991; 22: 515–523.

    14 Li Y. Tooth bleaching using peroxide‑containing agents: current status of safety issues. Compend Contin Educ Dent 1998; 19: 783–790.

    15 Leonard R H, Haywood V B, Phillips C. Risk factors for developing tooth sensitivity and gingival irritation in nightguard vital bleaching. Quintessence Int 1997; 28: 527–534.

    16 Heymann, H.O. Tooth whitening: facts and fallacies. Br Dent J 2005; 198:514.

    17 Three teeth whitening trials with 18 patients performed in Dr Zeev Mazor’s Private Dental Clinic, Ranana, Israel and the White Clinic, Lisbon, Portugal, May 2016.

  • research developments18 that are successfully used in many other areas of medicine19, BrightTonix has developed a low power radio-frequency (RF) system and method that can remove stains from teeth enamel resulting in whiter teeth.

    BrightTonix Y10 Tooth Whitening System is composed of a specially formulated safe whitening toothpaste that contains no dangerous toxins or chemicals, an ergonomic silicon mouthpiece, and the control device that emits low power RF current.

    BrightTonix’s specially formulated Y10 Toothpaste is applied to the

    18 Céspedes O et al. Radio frequency magnetic field effects on molecular dynamics and iron uptake in cage proteins. Bioelectromagnetics. 2010 May;31(4):311‑7.

    19 Sung R, Lauer M. Fundamental Approaches to the Management of Cardiac Arrhythmias. Springer Science & Business Media, 6 Dec 2012.

    4 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    A novel low power radio-frequency system

    Y10 Whiteniing Kit

    Y10 Product & Kit

  • 5 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    mouthpiece. The silicon mouthpiece is comfortably inserted by the dental professional within the patient’s mouth. The Y10 BrightTonix device is then turned on. RF current at a frequency of 7MHz flows through the Y10 Toothpaste. This treatment energizes the molecules within BrightTonix’s unique Y10 Toothpaste to approach the discoloured areas on the teeth. Collision and separation occur seven million times every second as a result of the electromagnetic field, causing the Y10 Toothpaste and the discoloration (stain) to interact. This interaction causes the stain to be pulled out from the enamel resulting in whiter teeth.

    Three recent trials performed in leading private dental practices in Israel and Portugal17, confirm Y10 by BrightTonix to be effective without side effects.

    The studies involved 18 volunteers, with no exclusion criteria. Three volunteers had specific tooth shades on the grey scale, that were not suitable for tooth whitening with existing hydrogen peroxide based methods. All volunteers visited a hygienist prior to treatment.

    The treatment protocol involved one 30 minute teeth whitening treatment with Y10 by BrightTonix (the device itself can perform preset treatment sessions of either 15, 20 and 30 minutes). Tooth color was assessed at baseline and after treatment by the clinician using an established and standardized scale of 29 shades, VITA Bleachedguide 3D_MASTER shade guide.

    1. The device generates radio frequency RF current

    2. Y10 toothpaste molecules are energized to approach discoloured areas on the teeth

    4. Y10 Toothpaste and the (stain) interact

    5. This stain is pulled out from the tooth enamel resulting in whiter teeth

    3. Collision and separation occur as a result of the RF current (7 million times/sec)

    How it works

    Study population and treatment protocol

    Clinical support

  • 6 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    Y10 effectively whitened teeth in all patients and for all shade groups, with an average tooth shade reduction of 3.6 (36 teeth). Improvements were seen in both the very dark (20-29), see Figure 2 and 3, and light (2-8) shade groups, see Figure 4 and 5, known to be difficult to treat with peroxide-based products.

    No side effects or complaints were reported by patients during and subsequently after treatment. Results were maintained one week later and after two months of treatment.

    Patients were extremely satisfied with their treatments.

    Results

    BEFORE /SHADE 25

    AFTER /SHADE 17

    Figure 1: Volunteer with tooth shade 25 before treatment vs. shade 17 after treatment (difference of 8 shades)

  • 7 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    BEFORE /SHADE 25

    AFTER /SHADE 19

    Figure 2: Volunteer with tooth shade 25 before treatment vs. shade 19 after treatment (difference of 6 shades).

    BEFORE /SHADE 13

    AFTER /SHADE 10

    Figure 3: Volunteer with tooth shade 13 before treatment vs. shade 10 after treatment (difference of 3 shades).

  • 8 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    BEFORE /SHADE 7

    AFTER /SHADE 5

    Figure 4: Volunteer with tooth shade 7 before treatment vs. shade 5 after treatment (difference of 2 shades).

    Figure 5: Volunteer with tooth shade 15 before treatment vs. shade 7 after treatment (difference of 8 shades).

    BEFORE /SHADE 15

    AFTER /SHADE 7

  • 9 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    ●Faster throughput: A complete treatment can be performed in as little as 15 minutes compared to a standard in-office peroxide treatment on average lasting over one hour.

    ●Safe & reliable: Y10 eliminates the need for home follow-up treatments, reducing the risk of inappropriate application or abuse by patients that can cause serious side effects.

    ●Cost-effective: Y10 requires less material as only one application is needed per treatment session compared with three applications for peroxide based treatments.

    ●Convenient: Y10 is a simple and straightforward procedure requiring no refrigeration and preparation.

    ●Multiple treatments: Y10 can be used as often as you would like it, providing a long-term frequent treatment solution for more demanding patients.

    ●Non-abrasive: Y10 whitening toothpaste contains no dangerous toxins or chemicals making it friendly to the enamel and lining compared with existing treatments.

    Y10’s in-office treatment advantages

  • 10 Revolutionary Teeth Whitening SolutionBrightTonix Medical Ltd.

    Summary and discussion

    For many years, the safety profile of peroxide-based products has caused controversy and concern. Mainly due to its unknown long-term safety profile, and high risk of inappropriate application in the home setting. Moreover, professional in-office treatments are time-consuming and expensive, and patients still need to perform home follow-up whitening sessions with further inconvenience and cost.

    BrightTonix’s Y10 Whitening System provides a new safe and effective treatment approach for dental practitioners. Initial studies show excellent results demonstrating its effectiveness to whiten teeth in all patients and for all shade groups. The whitening system also showed effect on the very dark and light shade groups, known to be difficult to treat with peroxide-based products. Whitening results were maintained in the long-term, with no complaints or side effects reported by patients. Patients were also extremely satisfied with their treatments.

    While peroxide based treatments whiten teeth via oxidative reactions of free radicals that interact with pigment molecules to produce the whitening effect. The Y10 system uses a unique patent pending technology based on RF waves to “pull-out” the stain from the enamel resulting in whiter teeth without the peroxide risks. This new technology, based on latest medical developments, enables shorter, more cost-effective in-office treatment sessions that can be repeated as often as desired by the patient. Furthermore, the Y10 system eliminates the need for inconvenient and costly home follow-up whitening sessions that without experienced dental supervision may be less safe for patients.

  • BrightTonix Medical Ltd is a medical device company located in Israel. The company’s breakthrough, Y10 whitening system aims to help dental practitioners and beauticians more efficiently, safely and effectively whiten teeth. The company is led by industry veterans from the aesthetic devices field, experienced engineers, and supported by leading dental professionals.

    For further information, please contact:Genady Nashon, [email protected]

    www.brighttonix.com

    About BrightTonix