ULTRASONIC TOOTHBRUSH. January 14, 2011 Asahi-irica Co.,Ltd.

Transcription

1 ULTRASONIC TOOTHBRUSH AU 300D January 14, 2011 Asahi-irica Co.,Ltd. 1

2 * * WHAT IS ULTRASONIC TOOTHBRUSH? Ultrasonic Toothbrush emits 1.6 million Herz Ultrasonic sound which is too high frequency for man to hear and to feel its sound and vibration. This Ultrasonic toothbrush performs the works which normal electric toothbrush or sonic toothbrush could not do ; to remove the plaque from teeth and to destroy the insoluble glucan caked with teeth, this is the best characteristic of Ultrasonic Toothbrush. Ultrasonic Toothbrush AU300D has been designed to emit ultrasonic vibration of 1.6 million Herz with addition of sonic sound vibration of 16,000 strokes per minute, which combination makes the best synergy effect. Asahi-Irica C0.,Ltd. 2

3 A message from the inventor. I am Robert Bock, a biomedical engineer, and the inventor of the ultrasonic toothbrush. I have studied the therapeutic effects of ultrasound1, and invented the original Ultrasonic toothbrush in The US FDA approved my Ultrasonic toothbrush, the Ultrasonex, in My invention was sold since 1992 under the UltraSonex and Ultima brand names in the USA, Canada, Europe and in Japan. The latest highly advanced model is produced and marketed in Japan under the Smilex brand name. Numerous clinical and laboratory studies1 of the various models of my ultrasonic toothbrushes in the past proven that they reduce plaque, gingivitis, gum disease, and bacteria in the mouth, greatly improving the dental hygiene of the user. Clinical studies documented the connection between periodontal bacteria in the mouth and various diseases of the body, particularly heart disease. Researchers have found that people with gum disease are almost twice as likely to suffer from coronary artery disease2. I recommend the daily use of the Smilex ultrasonic toothbrush for best dental hygiene. Use it with confidence. It will give you the best dental health, an improved general health and protection against cardiac disease. Sincerely, Robert T. Bock Asahi-Irica C0.,Ltd. 3

4 COMPARISON OF SONIC BRUSH AND ULTRASONIC TOOTHBRUSH Driving System Sonic Brush (USA made) Ultrasonic Toothbrush Vibration Frequ en cy 31,000 /minu te 16,000/min u te Ultrasonic Brushing Method non Touch the brush to the teeth and shifting slowly 1.6 MHz Like a man ual bru sh, brush the teeth with slight moving Easin ess Selection of Tooth Paste Effect Difficu lt to touch the bristle to the back With superfin e bristle and narrow vibration of front teeth and crooked teeth stroke, brushing is soft and comfortable Physical and mechanical removal of plaque1.6 MHz low OUTPUT Ultrasonic No abrasive included, low foaming Any type usable 1) teeth,by and 2)To To becomes destroy loosen which the adherence less plaque cilia adhererable of is of bacteria easy plaque to remove and to the damage to the structure give Asahi-Irica C0.,Ltd. 4

5 EFFECT OF ULTRASONIC TOOTHBRUSH ON PLAQUE, GINGIVITIS AND GUM BREEDING CLINICAL STUDY OF CLEVELAND CLINIC FOUNDATION Decrease Ratio (%) Max Plaque Index Manual Brush Group Ultrasonic Toothbrush Group Plaque Index Gum Breeding Index Gingivitis Inde Fig.1 Effect of Ultrasonic Toothbrush on Plaque, Gingivitis and Gum Breeding Test starting time 30 days later Fig. 2 Decrease of Plaque index after 30 Continuous use of Ultrasonic Toothbrush will repeatedly destroy the chain of insoluble Glucan which will be the cause of plaque. The tooth will become plaque free. Test result after 30 days are shown in Fig. 1 and 2. By controlling the adhesion of plaque, such effect as the decrease of gum breeding and gingivitis is observed. Asahi-Irica C0.,Ltd. 5

6 Effect of Ultrasonic Toothbrush on Bacterial flora under Gum Edge (Inside of periodontal pocket) Average Number of Total Bacterial Flora 5) unpublished data At test starting time 4 Weeks later Fig. 6 The effect of Ultrasonic Toothbrush on the Bacterial flora under Gum Edge Bacterial Flora 11 testees : specific three points are in advance decided in the periodontal area, and during the four test weeks two brushing per day is performed and the plaque taken thenafter, is cultured and the total number of bacterial flora is measured by DNA Probe system. As the result, there is a point where the number of bacterial flora has decreased 10 times, which makes totally the decrease of 21.8%. The total number of bacterial flora per one specimen was 3.9x10 6 CFU but 4 weeks later it has been confirmed that it decreased up to 3.9 x 10 6 CFU. Asahi-Irica C0.,Ltd. 6

7 Removal Effect of Streptococcus oralis with Ultrasonic Toothbrush Nippon University, Dental Department Dental Department, Preservation Study Periodontal Course Hiroyasu Iwasaki, Kyouko Mori, Kouichi Tsuruta, Kouichi Itoh Before irradiation of Ultrasonic After irradiation of Ultrasonic When the Ultrasonic is radiated to the insoluble glucan which is in chain of pieces and the origin of plaque, the chain is cut. Therefore, the ultrasonic toothbrush can be used as the oral cleaning tool. The experiment has been made on the removal effect of Streptococcus oralis which exists in chain as an origin of Plaque. It has been confirmed that bacterial chain becomes shorter, which evidence the control of formation ofplaque far better than the use of normal toothbrushes. Asahi-Irica C0.,Ltd. 7

8 Case Study of the effect of Ultrasonic Toothbrush - Actual use by subject people of the test #1 Subject Base Line One week later #7 Subject Base Line One week later For both subject people, adhesion of plaque was seen in the volume level f mid to high at the Base Line time (red part on the surface of tooth) but with use of Ultrasonic Toothbrush for one week the number of bacteria has been measured fairly reduced. Removal of plaque is obvious around the crooked teeth area (arrow mark). Asahi-Irica C0.,Ltd. 8

9 1. Observation of Ultrasonic functioning of Ultrasonic Toothbrush with Thermograph for verification 2. Time : From August 18 to 19, Place: Saitama Industrial Technology Center 4. Measurement Equipment: Thermography Produced by NEC Sanei Co. TH7102MX 5. Measurement Method; illustrated below Asahi-Irica C0.,Ltd. 9

10 Measurement of Blood Flow Testee Gums(Supersonic ) Value Average of blood flow volume Gums(sound sound) Lip(Supersonic ) Before After Difference Before After Difference Before After Difference Average Testing body ;SOUKEN Lab.. (http( ://www souken-lab lab.co co.jp jp/) 2.Examination day ;November 8, Number of testees ;3 4.Test methodology Laser Doppler PeriScan PIM Ⅱ;It measures it by using made by NEC Co., Ltd.. 1The laser Doppler measures the blood flow of the side of the jaw in the under gums. 2The massage head is lightly applied to gums of the jaw below for three minutes. 3The laser Doppler measures its gums that applied the massage head. 5.Test outcome /The mean value of three people is shown. /An increase in the blood stream is the large result in the case of the supersonic wave. /For your information, the massage head was applied to the lip and it measured it. 6.Examination scenery Gum Disease Links to Heart Disease and Stroke The American Academy of Periodontology (AAP) Researchers have found that people with gum disease are almost twice as likely to suffer from coronary artery disease. Asahi-Irica C0.,Ltd. 10

11 Low-Intensity Ultrasound in Medicine and Dentistry Scientific experimenting with ultrasound in medicine and biology started in 1927 with the observation of intracellular stirring, heating, and cell lysis.[1] The actual medical application of ultrasound dates back to the 1950s. Ultrasound has been used as a therapeutic agent, mainly as a means of stimulating the repair of soft tissue injuries, damage to ligaments, inflammation of tendon sheaths, and soreness. Therapeutic ultrasound equipment typically operate at 1-3 MHz, and at an intensity of 100mW/cm2 to 3 W/cm2. The next major advancement came in the 1960s with the development of sophisticated diagnostic instruments. This advancement was driven by the ability to visualize soft tissues without ionizing x-ray radiation. The ultrasonic imaging technology utilizes higher frequency (.75 MHz - 6 MHz) but relatively low intensity ultrasound (1-50 mw/cm2), chosen specifically to avoid tissue heating, to safely image body tissues, including fetal examinations. As the safety of this technology became well established [17] the use of ultrasound imaging machines propagated throughout the world. Electronics miniaturization and advancement of microprocessor technology during the 1980s opened the door for widespread experimentation with high-frequency and low-intensity ultrasound in the medical field, particularly in the bone and tissue healing fields. Asahi-Irica C0.,Ltd. 11

12 Bone Healing. L. R. Duarte, one of the early experimenters, was at the University of Sao Paulo, in Brazil. Duarte found in 1983 that the daily application of 1.6 MHz ultrasound significantly accelerated the healing of bone fractures, particularly in the first days of treatment, even at very low intensities[2]. Various animal studies confirmed Duarte's findings. Animal study [3] shown that ultrasound increased the rate of return of mechanical strength. The ultrasonically treated osteotomy achieved intact strength approximately 1.7 times as fast as its non-treated contra-lateral control. Shyu-Jye Wang also confirmed that 1.5 MHz ultrasound accelerates fracture repairs in 21 days [4]. A. A. Pilla at the Mount Sinai School of Medicine, New York, investigated the dose response of lowintensity ultrasound at 1.5 MHz and its effect on the healing of rabbit osteotomy. Pilla found statistically significant beneficial effects of ultrasound between 7.5 mw/cm2 and 45 mw/cm2 in his studies [5]. It is important to note that Pilla also observed healing at an intensity as low as 1.5 mw/cm2,albeit not statistically significant in a short 17 days period. A large scale multicenter clinical study at The University of Texas Health Science Center at San Antonio, Texas documented the effectiveness of ultrasound treatment of bone fractures in humans. The study concludes that a twenty-minutes per day application of ultrasound accelerated the average healing of fractures by 24.6% [6]. The US FDA approved the first device to speed healing of fractures in October Subsequently Exogen, Inc. started marketing the SHAFS device in the USA [7]. Asahi-Irica C0.,Ltd. 12

13 Tissue Repair and Angiogenesis. Researchers S. R. Young and M. Dyson are the leaders in the wound healing field. Young and Dyson have focused their research on MHz low intensity (100 mw/cm2) ultrasound. Young and Dyson demonstrated that ultrasound can accelerate the early phase of wound healing [8]. Dyson concludes that there is some evidence that ultrasound can effect wound contraction, all or part of a skin defect by the centripetal movement of the surrounding skin. Angiogenesis, the development of new blood vessels or repairing them, is a vital part of wound healing, re-establishing circulation at the injury site. Young and Dyson also studied the effect of low intensity ultrasound on angiogenesis [9]. They have concluded that "the results from this work suggest that ultrasound can affect the early phase of the repair process, i.e., the inflammatory phase". Asahi-Irica C0.,Ltd. 13

14 Dental Health. The major challenge in dentistry is the prevention of gingivitis, the inflammation of the gums. Prevention is often not possible for various reasons, and large percentage of the population world-wide suffers from this. When gingivitis detected in an early stage, it is treated by antibiotics. If it is not detected early enough, gingivitis will cause damage (wound) to the gums, attack the capillary blood vessels of the gums, and begin a process of pocket formation between the gums and the root of the teeth. These pockets collect harmful bacteria, which further increases the level of inflammation. At this stage gingivitis advances into periodontitis, requiring oral surgery to reduce the size of the pockets. If periodontitis is not treated early it can lead to bone loss, both on the roots of teeth and the jawbone. Review of the clinical research in the field of tissue repair and bone healing suggested that low intensity ltrasound could be useful to reverse gingivitis (inflammation of gums) and the associated gum bleeding. It was postulated that perhaps ultrasound could help pocket contraction as in [8], help capillary blood vessels as in [9], and even help bone healing as in [2-6]. Because high-frequency ultrasound at an intensity below 100 mw/cm2 was proven safe [17], the sought occurred that the ideal device to treat gingivitis could be the incorporation of such an ultrasound modality into a toothbrush. Utilizing the toothbrush as an ultrasound delivery vehicle, daily application of ultrasound to the oral tissues would not be an extra laborious task for the user. The additional advantage of such a toothbrush could be the prevention of the occurrence of gingivitis. Sonex International Corporation was formed in 1991 for the purpose to research the use of ultrasound in dentistry. The first experimental model of the Ultrasonic Toothbrush confirmed that the application of 1.6 MHz low intensity ultrasound, suggested by the prior published scientific literature, indeed has a beneficial effect to reduce the inflammation of gums. A significant improvement of plaque removal was also evident versus the nonultrasonic control. Sonex International Corporation received US FDA clearance to market the first Ultrasonic Toothbrush in December Asahi-Irica C0.,Ltd. 14

15 History and Research Studies of the UltraSonex Ultrasonic Toothbrush. The original Sonex and UltraSonex toothbrush models were essentially manual toothbrushes with the addition of a 1.6 MHz ultrasound generator in the handle and a piezo-electric crystal in the brush head. Patients used this toothbrush just like using a manual toothbrush. Numerous clinical and laboratory studies confirmed the safety and effectiveness of this Ultrasonic Toothbrush. The studies documented:. 97% Plaque Reduction, 60% Bleeding Reduction, 28% Gingivitis Reduction in 30 Days, Published Clinical Study [10].. 74% Overnight Plaque Formation Reduction, 65% Gingivitis Reduction in Six Months, Published Clinical Study [11].. 46% Reduction of Oral canker sore (Recurrent Aphthous Stomatitis) in six months, Published Clinical Study [12]. Rupturing chain formation of S. mutans, damaging bacteria cells. Inhibiting the adherence of S. mutans on enamel surfaces. Published Laboratory Study [13].. 83% Bleeding Reduction, 47% Gingivitis Reduction in twelve weeks, Double Blinded Clinical Study, Unpublished data [14].. 67% Reduction of Subgingival Bacterial Flora, Unpublished Clinical Study [15].. 46% Reduction of periodontal pockets deeper than 5 mm, Unpublished Clinical Study [16] Asahi-Irica C0.,Ltd. 15

16 New toothbrush models were later developed. In addition to the ultrasound, these newer models are now incorporating an electric motor and motion transducers to provide "motorized" bristle vibrations to the system. These newer systems retain all of the advantages of Ultrasound, with the additional advantage of a sonic frequency bristle vibration. The new models extended the appeal of these Dual Frequency toothbrushes to the elderly, and to handicapped persons. The Ultrasonic Toothbrush technology is being further advanced today. The new models provide higher ultrasound energy output to further improve the effectiveness of the Ultrasonic Toothbrush. Robert T. Bock Robert T. Bock Consultancy LLC January, 2010 Asahi-Irica C0.,Ltd. 16

17 References: 1. Wood, R.W., and Loomis, A. L.: The physical and biological effects of high frequency sound waves of great intensity. Phil. Mag. 4: , Duarte, L. R.: The Stimulation of Bone Growth by Ultrasound, Arch Orthop Trauma Surg (1983) 101: Pilla, A. A. et. al.: Non-Invasive Low-Intensity Pulsed Ultrasound Accelerates Bone Healing in the Rabbit, Journal of Orthopaedic Trauma, Vol. 4, No. 3. pp , Wang, Shyu-Jye, et.al. : Low Intensity Ultrasound Treatment Increases Strength in a Rat Femoral Fracture Model, Journal of Orthopaedic Research 12:40-47 The Journal of Bone and Joint Surgery, Inc Pilla, A. A. et. al.: Acceleration of Bone Repair by Pulsed Sine Wave Ultrasound, Animal, Clinical, and Mechanistic Studies, Electromagnetics in Biology and Medicine, Heckman, J. D. M. D., et. al.: Acceleration of Tibial Fracture-Healing by Non-Invasive, Low-Intensity Pulsed Ultrasound, The Journal of Bone and Joint Surgery, Vol. 76-A, No. 1 pp , January, Exogen, Inc.: SAFHS The exciting new non-invasive technology, brochure and specifications. 8. Young, S. R. and Dyson, M.; Effect of therapeutic ultrasound on the healing of full-thickness excised skin lesions, Ultrasonics, 1990 vol. 28 May, pp Young, S. R. and Dyson, M.; Effect of therapeutic ultrasound on Angiogenesis, Ultrasound in Med. & Biol. Vol. 16, No. 3, pp , Terezhalmy, Geza T., et.al., : Clinical Evaluation of the Efficacy and Safety of the UltraSonex Ultrasonic Toothbrush: A 30 Days Study, Compend Contin Educ Dent, Vol. XV, No. 7, , Terezhalmy DDS, Geza T., et.al., : Clinical evaluation of the effect of an ultrasonic toothbrush on plaque, gingivitis, and gingival bleeding: A six-month study, The Journal of Prosthetic Dentistry, pp , January, Bryce MD, Sylvia L.,: Clinical evaluation of the use of low-intensity ultrasound in the treatment of recurrent aphthous stomatitis, Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997; 83: Shinada, Kayoko, et.al., : Effects of Ultrasonic Toothbrush on Streptococcus mutans, The Japanese Journal of Conservative Dentistry, Vol. 42, No. 2 (1999). 14. Case Western Reserve University, School of Dentistry, Master's Thesis, Unpublished Data, G. H. Besselaar Associates Clinical Research Unit, Efficacy of the Ultrasonic Toothbrush in Reduction of Subgingival Microbial Flora, Unpublished data, August, Spino, F. J., D.D.S., F.A.G.D., :Clinical Evaluation of the Effectiveness of the Sonex Ultrasonic Toothbrush in the Reduction of Periodontal Pockets, Unpublished Data, Circa American Institute of Ultrasound in Medicine: Bioeffects and Safety of iagnostic Ultrasound, Asahi-Irica C0.,Ltd. 17