Below is an overview of the research conducted so far to analyse the effectiveness of “manadental” photodynamic cleaning. Research is ongoing, and this page will be updated with future results.
Photodynamic therapy (PDT) has been the subject of thorough scientific research, and it has been successfully used for several decades in various indications. PDT can be described as a process for careful elimination of pathogenic bacteria without the risk of development of resistance. [1]
Planned elimination of bacteria involves bringing the bacteria into contact (“colouring” the bacteria) with a photosensitising substance (photosensitiser) and subsequently illuminating the bacteria with light of a suitable wavelength. This triggers photophysical processes where “reactive oxygen species” which are toxic for bacteria cells are produced. [2],[3]
The photodynamic cleaning system used is a simple device, suitable for domestic use as an oral hygiene product, designed to produce targeted illumination and containing easily tolerable photosensitisers and ingredients. The key elements of the process are the targeted effect of photodynamic treatment, restricted to the “coloured” bacteria, and the fact that the photosensitiser and the light penetrate areas where conventional dental hygiene products do not reach.
The “manadental” product, developed to enable photodynamic cleaning, has been designed as an innovative tool for everyday oral hygiene with the aim of protecting and maintaining all-round oral health.
To analyse the effectiveness of “manadental” photodynamic cleaning, series of tests were conducted in a laboratory (in vitro) and a study was conducted with test subjects (in vivo).
Study conducted by: Diagnostic and Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz
Client: Mana Health Technologies GmbH
1. Aim of the tests
The aim of these tests was to investigate the antibacterial effect of the “manadental” oral photodynamic cleaning system developed by Mana Health Technologies GmbH on the pathogenic oral bacteria Streptococcus mutans. As a comparison, two conventional, commercially available mouthwashes were tested for their antibacterial effectiveness.
The test method was to use the indicator bacteria Streptococcus mutans as an example to investigate in vitro the extent to which the process can reducing the number of colony forming units (CFU/m
2. Materials and methods
Before illumination, the pathogenic oral bacteria Streptococcus mutans was incubated for 48 hours on COL-S agar plates at 37°C with 5% CO2 concentration, then suspended in 0.9% NaCl and set to a defined starting bacteria number (107 - 108) using OD600 measurement. For the test, the bacteria suspension was mixed with the solutions to be tested (riboflavin rinse, conventional mouthwash 1, conventional mouthwash 2).
The LED light source used for the testing has a polychromatic emission spectrum which includes the wavelength at the required energy level necessary for photophysical stimulation of the riboflavin. The illumination was applied in 5-minute (300-second) cycles.
The photodynamic rinse was a water-based solution with a special vitamin B2 (riboflavin) derivative as a photosensitiser. The formula was designed to be a mouthwash and therefore contains flavourings and additional active ingredients, which have a synergistic relationship with the primary photodynamic effect.
After manipulation and incubation with the mouthwashes, the solutions were mixed again with the pipette and diluted and plated in a 1:10 dilution series up to 107. Each test was evaluated twice in the form of a technical replicate. The photodynamic illumination was also designed as a biological replicate.
The following test methods were compared with each other:
3. Results
The results of the test methods can be found in the following table:
The results of the testing prove that neither illumination alone (BK) nor the isolated riboflavin rinse (RK) have demonstrable bactericidal effects compared to the growth control (WK1 and WK2). By contrast, the combination of illumination and riboflavin rinse (BES I, BES II) demonstrates a strong antibacterial effect against Streptococcus mutans (bacteria reduction of ~5.5 log levels) in the test.
The relative difference in effectiveness between the conventional mouthwashes (SP1, SP2) and the photosensitising illuminated riboflavin rinse (BES I, BES II) is ~3.0 log levels in the test. As three logarithmic units (3.0 log levels) mean a percentage reduction of 99.9%, it can be assumed that the manadental photodynamic cleaning system is 99.9% more effective against Streptococcus mutans than the tested conventional mouthwashes.
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4. Interpretation and summary
The results of this testing indicate that the antimicrobial effect of the photodynamic system under test is much greater than the conventional mouthwashes with incubation as specified by the manufacturer
(Fig. 1).
Study conducted by: Dr Andreas Inthal, Velden am Wörthersee, for Mana Health Technologies GmbH
Client: Mana Health Technologies GmbH
1. Aim of the study
The aim of the study was to measure and evaluate the effectiveness of oral photodynamic cleaning using a new system. The “manadental” product system to be tested was designed, developed and introduced to the market by Mana Health Technologies GmbH. 28 test subjects took part. The study was conducted under the leadership of principal investigator Dr Andreas Inthal on behalf of Mana Health Technologies GmbH. Dr Inthal is the principal investigator at Mana Health Technologies GmbH, is involved as an investor, and played a significant role in developing the “manadental” photo dynamic cleaning product.
The “manadental” product to be tested is not subject to the Austrian Medicinal Products Act (Arzneimittelgesetz) or the Austrian Medical Devices Act (Medizinproduktegesetz). The electronic device (measuring glass, charging point, emitter) is a consumer product for the purposes of the Product Safety Act (Produktsicherheitsgesetz). The photodynamic liquid is classified as a cosmetic product. In accordance with EC Regulation No 1223/2009 and EU Regulation No 655/2013, the principal investigator took the necessary ethical and safety considerations into account before the study began, and the study was conducted in accordance with good scientific practice.
A group of test subjects was studied using objective clinical parameters for effectiveness on gums and a colour comparison, and the subjective opinions of the test subjects were also obtained.
2. Test subjects, materials and methods
28 test subjects took part in the study, which was conducted at the medical practice of principal investigator Dr Andreas Inthal. The devices and the photodynamic liquid were supplied by Mana Health Technologies GmbH. Participation for each test subject was limited to 3 weeks.
The test subject group was composed of healthy individuals in good general condition between the ages of 20 and 75. Participation in the study was voluntary, and the test subjects could withdraw at any time without providing reasons.
The “manadental” product was given to the test subjects with all its packaging, which included detailed instructions. The test subjects were also given detailed training in how to use the product at the medical practice. During the 3-week observation period, the test subjects used the product every other evening before brushing their teeth.
2.1 Endpoints
The primary endpoint of the study was to test the effectiveness of the product on gum health using bleeding on probing (BoP). The secondary endpoints were to test the impact of the product on tooth colour and to analyse the perception of the product using an anonymous questionnaire.
2.2 Bleeding on probing
To evaluate the condition of the gums, bleeding on probing (BoP) in accordance with Ainamo & Bay 1975 was used. A blunt probe is pressed against defined measuring points on the gingival margin, with a dichotomous yes/no answer to whether pressing the probe produces bleeding. There are six measuring points distributed across the sulcular circumference of the tooth (in fully mature teeth, this results in 32 x 6 = 192 measuring points) where a yes/no answer is recorded. If BoP follows the exact Ainamo & Bay 1975 method, the total number of bleeding measuring points is expressed as a percentage of the total number of all measuring points. [4],[5]
In the present study, a common modification of the Ainamo & Bay BoP method was used. The result given using this modification expresses the total number of bleeding teeth in relation to the total number of probed teeth. This is in contrast to the conventional calculation, where the number of bleeding measuring points is expressed in relation to the total number of all measuring points. Using this modification, a tooth where bleeding caused by probing has been reduced from 5 points to 1 point (for example) is still recorded as “bleeding”. This makes the parameter even more robust. To further reduce the risk of bias on the part of the principal investigator, and in accordance with good scientific practice, a periodontal probe (WHO probe) pressure-calibrated to 0.2N was used.
2.3 Tooth colour card comparison
To record the tooth colour, the “Classical” colour scale from VITA® was used. The shades cover the A1-D4® shade range. The three-dimensional replica teeth in the corresponding A1-D4 shades are held up next to each tooth and compared. [6]
2.4 Questionnaire
A questionnaire including open questions, multiple choice questions, scale questions and polarity scales was used to evaluate subjective opinions. Quantifiable question models with percentage and/or absolute numbers in pie charts or bar charts were used to evaluate the results.
3. Results of bleeding on probing
Bleeding on probing was tested on an average of 26.6 teeth (median 28, minimum 21, maximum 30) per test subject. Before the intervention, bleeding on probing was found in an average of 18.4 (20; 2-28) teeth; after the intervention, it was only found on 11.5 (10.5; 0-22) teeth. This decrease was highly significant (Wilcoxon test for paired samples: z = 4.627, p < 0.0001; Fig. 1; Fig. 2).
The number of bleeding teeth decreased by an average of 43.1%. In all test subjects, the tendency to bleed was reduced during the observation period.
4. Results of the tooth colour comparison
As determined by the defined tooth colour cards, the tooth colour comparison showed no change in colour for 23 test subjects (82.1%) and a brightening in 5 test subjects (17.9%). Darker colours were not observed in any of the test subjects after the intervention (Fig. 3).
5. Analysing the questionnaire
The following section explains several aspects of the questionnaire analysis. The test subjects filled out the anonymous questionnaire after using the product for 3 weeks and before the subsequent examination, to avoid influencing their subjective opinions.
5.1 Mouthfeel: “Please evaluate your mouthfeel immediately after using the product”
This question served to evaluate “subjective mouthfeel” in the test subjects after using the product for 3 weeks. They could choose from the following potential answers: My mouth feels less clean. My mouth feels as clean as before. My mouth feels cleaner. (Fig. 4)
5.2. Ergonomics: “Please evaluate the illumination in your mouth from unpleasant (1) to pleasant (5):”
This question allowed the test subjects to give their subjective opinion of the ergonomics of the “manadental” product after using it for 3 weeks. The answers were evaluated using a polarity scale ranging from unpleasant (1) to pleasant (5). On average, the product was rated 4.36 out of 5 in terms of ergonomics, which demonstrates that the “manadental” product is pleasant to use. (Fig. 5)
5.3 Effectiveness: Your subjective opinion of the effectiveness of “manadental” after 3 weeks
This question allowed the test subjects to give their subjective opinion of the effectiveness of the “manadental” product after using it for 3 weeks. They could choose from the following potential answers: My oral health has got worse. My oral health has remained the same. My oral health has improved. (Fig. 6)
5.4. Benefit: Would you be happy to continue using this product in your everyday life?
This question allowed the test subjects to give their subjective opinion of the possibility of continuing to use the “manadental” product after using it for 3 weeks. They could choose from the following potential answers: Yes. No. Unsure. (Fig. 7)
6. Interpretation and summary
Previous in vitro studies have demonstrated that the photodynamic cleaning system has an impressive effect on the pathogenic oral bacteria Streptococcus mutans. This method reduces bacteria by approx. 5.5 log levels and is approx. 3 log levels (99.9%) superior to conventional mouthwashes.
The results of the in vivo effectiveness of the “manadental” photodynamic cleaning system, measured using the BoP parameter, show a highly significant improvement in the condition of the gums. (Wilcoxon test for paired samples: z = 4.627, p < 0.0001; Fig. 1; Fig. 2).
The average improvement in the BoP parameter during the observation period was 43.1%. Overall, an improvement in this parameter was identified in all test subjects, and there was no case of stagnation or of deterioration in the condition of their gums.
In consideration of the robust BoP parameter, it is noteworthy that these results are extremely clear. Based on their clinical experience, the principal investigators and the specialists conducting the study consider the objective improvement during the observation period to be a success.
The results of the tooth colour card comparison suggest that using the photodynamic cleaning system does not lead to discolouration of teeth. In addition to the tooth colour card comparison, the principal investigators did not identify any partial discolouration of the enamel or the gums in the second examination. The principal investigators and the specialists conducting the study consider the slight brightening in tooth colour identified in 5 test subjects during the observation period to be insignificant. The steps in the scale were small (0.5-1 VITA® scale units) and were overwhelmingly identified with a brighter basic tooth shade (AX), which experience has shown can more easily be influenced by variable light in the room and test subject bias.
In this study, no side-effects were observed from use of the photodynamic cleaning system on the basis of the measured parameters, general observation of oral health and in the follow-up consultation in the final examination.
This study shows a highly significant improvement in gum condition in the test subjects after using the “manadental” photodynamic cleaning system for 3 weeks. No immediate side-effects of the photodynamic cleaning system were observed.
Literature
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