#. Introducion to develoment of Laser toothbrush
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#. Clinical trial of Laser toothbrush
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Method
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We adopted the following clinical trials in order to prove the effects of Laser toothbrush.
* Title : A Comparative, Multi-Center, Double Blind, Randomized Clinical Trial to Assess the Safety and Efficacy of the “Laser Toothbrush,"
Clinical Trial Results
In the reference, dentin hypersensitivity patients visited a hospital and received low-level laser therapy from a medical specialist.
The best result they found was 3.17. We compared clinical trial data based on this figure.
* Instrument for Clinical Trial : The Laser Toothbrush
* Method: The subjects of the test group shall use Laser Toothbrushes for one month. The subjects of the control group shall use placebo Laser Toothbrushes for one month. We measured and compared scores on the Visual Analog Scale (VAS) one month after start of treatment. The VAS is used to objectively evaluate pain, which is subjective.
* Number of Trial Subjects : 96 subjects were collected; Nine subjects failed to complete the trial.
A total of 87 subjects completed the clinical trial.
It was also proven that Laser Toothbrush does not have any negative effect on the human body.
* Trial Period : February 16, 2009 to April 8, 2009
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* Initiator: Medical & Human Technology Co., Ltd.
Medical & Human technology Co., Ltd. is a company that specializes in developing and researching new medical instruments that improvehealth. During our research, we collected a great deal of clinical trial data regarding the successful use of Low Level Laser Therapy totreat Dentin Hypersensitivity. We discovered a majority of Korean citizens suffer from Dentin Hypersensitivity, but that the only treatmentthey can had for the symptoms is to make an appointment with a dentist, and nothing else. As a result, the senior management andresearch team of Medical & Human Technology Co., Ltd. decided to develop a new way to treat Dentin Hypersensitivity by using anddevloping a Low Level Laser Treatment toothbrush emitted at the bristles.
The "Laser toothbrush" is a cutting edge medical instrument that improves quality of life. Medical & Human Technology Co., Ltd. has puta great deal of effort into developing this product. Medical & Human technology Co., Ltd. has carefully analyzed similar products fromother companies, and designed the Laser toothbrush in a way that assures the stability of the product, protects users, and maximizes thefunctionality of the toothbrush. It aims to improve the dental health of not just Koreans, but people all around the world. The LaserToothbrush has been registered with 3 patents after technical evaluation by the government, and is an applicant for an internationalpatent, PCT. Medical & Human technology Co., Ltd. will continue researching new technology such as this.
* Symptom: Dentin Hypersensitivity
a Low-Level Laser Therapy Toothbrush for the Treatment of Dentin Hypersensitivity
* Facilities and directors of the clinical trial: Kook Yoon-ah, Associate Professor, The Catholic University of Korea, Seoul, St. Mary's Hospital
: Baek Seung-hak, Associate Professor, Seoul National University Dental Hospital
It was evaluated that treatment of Dentin Hypersensitivity using the Laser Toothbrush is effective.
Medical specialist best result［3.17］ : Laser toothbrush trial statistics ［2.44］ = 77%
At the one-month time-point (Visit 3) for the ITT Set, the mean differed with the baseline by -3.31±1.79 for the treatment group, and by-0.88±1.86 for the control group. Also, when normality was tested, it did not sufficiently meet the qualifications for normality, so theWilcoxon’s rank sum test was used to see if any difference existed in the two groups. The results showed that significant differences didexist between the control group and the treatment group (p-value = 0.0001).
Before the study of the low level Laser Toothbrush in comparison to the placebo laser toothbrush, differences in VAS between thetreatment group and the control group did not exist. However, after the study, a significant effect was observed in the treatment group.Although the effective outcome can be attributed somewhat to the placebo laser toothbrush, the treatment group was able to lower thesensation of pain by a remarkable difference: 2.44±1.83 in VAS. Therefore it can be said that the effectiveness of laser toothbrush usecompared with placebo is clear.
For the above reasons, we find that the low-level Laser Toothbrush is considered to be an effective clinical tool for reducing pain thatarises from dentin hypersensitivity.
M&H
ERIC SONG Global consulting 82-10-6771-2220
#. Registration and certificates of Laser toothbrush
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Korean Food and Drug Association (KFDA): Permission of manufacture of the medical instrument
Korean Food and Drug Association (KFDA): Permission of manufacture of item of the medical instrument
Korean Food and Drug Association (KFDA): Good Manufacturing Practice(GMP) of the medical instrument
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RoHs -- EU
FDA -- U.S.
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#. What is Dentin Hypersensitivity?
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#. Achievements of Laser toothbrush
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The product has been proven to be effective as well as safe. Please use it without reservations.
The Laser Toothbrush developed and manufactured by Medical & Human Technology Co., Ltd. is intended for the treatment and relief ofthe pain of dentin hypersensitivity, and has completed clinical trials adopted by Seoul National University Dental Hospital and The CatholicUniversity of Korea, Seoul, St. Mary's Hospital, and has received permission to be manufactured as a medical instrument by the Korean
This product is world's first device to treat dentin hypersensitivity that can be applied at home without any medical treatment by a
As you get older, your gums shrink, exposing the root of the gum, causing the root to decay. Due to improper brushing of teeth, enameland cementum is abrased, exposing the dentin. When the exposed dentin gets stimulated, it affects the pulp as well, causing pain anddiscomfort issues. Stimulation of the exposed dentin comes from everyday life, such as the cold water you use when brushing your teeth,cold drinks, acid drinks or sweet foods, and cold air inhaled during winter, among other stimulations. When these kinds of stimulationsaccumulate, teeth can feel hypersensitive even when touched with a toothbrush, which can causes a decrease in quality of life. Therefore,dentin hypersensitivity is not just a sensation you feel, but a pain that can be very serious. Dentin hypersensitivity is a short and acutepain that occurs when thermal, evaporating, mechanical, osmotic, or chemical stimulations are applied to exposed dentin rather than due
GOST -- Russia
Patents of the Laser Toothbrush
Three Korean patents registered
We brush our teeth every day. But there is no toothbrush that can treat the pain caused by dentin hypersensitivity.
When the laser toothbrush is used in addition to normal tooth brushing, you can maintain clean teeth and ease the pain of dentinhypersensitivity at the same time.
The existing references show that low-level laser therapy can show better results when used more frequently. That is why we expect thatour product, The Laser Toothbrush, can restore dental health and improve quality of life when used on a regular basis.
The pain of dentin hypersensitivity can be quite confusing for both patients and dentists, because most patients are not sure where thepain comes from, or which tooth is in trouble. It is also very hard for dentists to diagnose which tooth is exposed and causing the pain.However, it is ovbious that the pain is a proof that the dentin is exposed and needs treatment. Not all dentin that are exposed show thiskind of pain. The pulp is very defensive of its own tissues, and when the dentin gets exposed slowly throughout a long period of time, thepulp can create a layer for the dentin to protect it. In this case, even when the root is exposed very noticeably, the tooth does not showany specific pain. On the other hand, a very recent exposure of the dentin which is hardly noticeable can be very painful. If the warningsigns like this are not taken care of, the pulp tissue will be damaged severely and will eventually need complicated treatments for the root
Cited from the website of Seoul National University Dental Hospital
Certificates for Laser Toothbrush
CE［ Laser toothbrush Dr.M ］-- EU
CE［ Laser toothbrush Dr.T ］-- EU
Official permission of Laser toothbrush
Application for Internation Patent, PCT
Human dental matter is the hardest tissue in the body.
The tooth consists of a crown which is the main body of tooth, and the root which is located deep in the jaw bone. The root is made up ofteeth enamel that surrounds the outside of the root, and dentin that is located inside of the root. Inside of the root is pulp that consists ofvarious cells, blood vessels, and nerve fibers. The enamel surrounding the crown, and outside of the root is cementum.
CB -- CB scheme
SASO -- Saudi Arabia
http://www.mnhtw.com
Medical & Human Technology Co., Ltd. will do its best to seek ways to help people improve their dental health all over the world.