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A Comparative, Multi-Center, Double Blind, Randomized Clinical Trial to Assess the Safety and Efficacy of the "Laser Toothbrush," a Low-Level Laser Therapy Toothbrush for the Treatment of Dentin Hypersensitivity
- Trial Period
February 16, 2009 to April 8, 2009
- 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
- Instrument for Clinical Trial
The Laser Toothbrush
Medical & Human Technology Co., Ltd.
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.
- 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.
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 the Wilcoxon’s rank sum test was used to see if any difference existed in the two groups. The results showed that significant differences did exist 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 the treatment 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 the sensation of pain by a remarkable difference: 2.44±1.83 in VAS. Therefore it can be said that the effectiveness of laser toothbrush use compared 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 that arises from dentin hypersensitivity. It was also proven that Laser Toothbrush does not have any negative effect on the human body.