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Ulticlean Prophylaxis Sales Folder

Ulticlean Prophylaxis Powder STANDARD (for supragingival use) Base “Bicarbonate”

Ulticlean Prophylaxis Powder PERIO PLUS (for sub- and supragingival use) Base “Tagatose“

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ULTICLEAN PROPHYLAXIS

Supragingival Introduction The modern prophylaxis treatment by means of a powder jet cleaning is now part of every visit to a dentist. Discolouration and biofilm such as plaque can be removed from the tooth and tooth root surfaces in a particularly efficient manner. While continuing to being very popular, sodium hydrogen carbonate powders have been used for supragingival cleaning for more than 20 years. Sodium hydrogen carbonate has a good compatibility for the patients. However, the removal of exposed root or dentin surfaces leads to measurable erosion as well as the taste is often described as “somewhat salty” for most patients.

Subgingival

BA Ulticlean Prophylaxis Powder PERIO PLUS , which has been newly developed is based on the non-cariogenic sugar tagatose. This has been specially developed for the gentle cleaning of the tooth both in the sub-and supragingival areas, as well as implant surfaces. On the one hand BA Ulticlean Prophylaxis Powder shows an excellent and fast cleansing effect. On the other hand, it is uniquely gentle on the tooth and root surface due to its optimised particle size and special particle geometry. It also provides an outstanding polishing performance. Our Ulticlean powder range enables a particularly gentle, extremely effective

and rapid prophylaxis treatment. Due to the special grain geometries of the powder, the tooth surface is already polished during the cleaning. This means that there is an extra final polishing of the tooth surface! These special features lead to a shorter and more pleasant treatment for the patient.

Because of the above features, this makes the BA Ulticlean Prophylaxis Powder PERIO PLUS unique.

G NEW

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ULTICLEAN PROPHYLAXIS

Specific Product Information for all Products in the Series All our developed prophylaxis powders have the following important formulation commonalities: A) Homogeneous and very narrow particle size range for a very uniform beam energy -> perfect and even working possible

B) Optimised coating of powder particles for ideal time-delayed water solubility Powder must not dissolve or clump too quickly in water and at higher humidity; however, it must dissolve completely when disposed of through the treatment units in water to prevent blockage Powder therefore remains very free-flowing even after long storage periods C) Pleasant taste optimisation in our Ulticlean prophylaxis Standard Powder through balanced natural flavour components and non-cariogenic sweeteners D) Significantly reduced dust behaviour by avoiding extremely small powder particles and optimised formulation E) No clogging or blockage and suitable for all air polishing units/devices -> perfected flowability and homogeneous coating F) No separation of the powder components during transport or storage -> Avoidance of segregation effects and inhomogeneities As a result, our powders differ very positively and significantly with many quality points compared to competitors in the market.

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ULTICLEAN PROPHYLAXIS POWDER STANDARD

The Classic Among Prophylaxis Powders Ulticlean Prophylaxis Powder Standard, based on sodium bicarbonate, is the classic among prophylaxis powders. Because the traditional sodium bicarbonate has an unpleasant and salty taste. We have developed a new combination of natural flavours and a non-cariogenic natural sweetener. Not only is this newly developed classic for supragingival tooth cleaning effectively removes biofilm (plaque) and heavy stains (i.e. coffee or wine or cigarette tartar), it also has a pleasant taste. If necessary, the tooth surface can be pretreated optimally with Ulticlean Prophylaxis Powder Standard for further treatments. Grain Size and Particle geometry A medium grain size of approximately 40μm was chosen for our Ulticlean Prophylaxis Powder Standard, as this grain size is ideal for cleaning stubborn discolouration and thorough removal of plaque. As shown in Figure 1, our Ulticlean Prophylaxis Powder Standard has a volume-related average particle size of d (50) = 43μm. The values d (10) = 10 μm, d (90) = 101 μm describe the width of the volume related particle size distribution. For a direct comparison, the commercially available EMS AIR-FLOW Classic Comfort and Ulticlean Prophylaxis Powder Standard were examined with a light microscope (see Figure 2). Here, it was found that the sodium hydrogen carbonate-based

Figure 1: Volume-related particle size distribution (d (50) = 43μm, d (10) = 7.4μm, d (90) = 101μm) of the developed Ulticlean Prophylaxis Powder Standard.

––––– Natriumbicarbonat - Average, Mittwoch, 13 September 2017 20:03:38

4 We rate this rather small but recognisable difference in Ulticlean Prophylaxis Powder as very positive. We also observed excellent cleaning in abrasion tests with very low and gentle removal of dental hard tissue. The rounder and more irregular particles are an advantage! www.bainternational.com EMS AIR-FLOW Classic Comfort (see Figure 2, left) has a very similar composition compared to the sodium hydrogen carbonate Ulticlean Prophylaxis Powder Standard (Figure 2, right). However, the EMS AIR-FLOW Classic Comfort powder shows more pointed and more crystalline particles, while Ulticlean Prophylaxis Powder Standard shows a rounder and more irregular particle geometry, which has a positive effect.

Certified to EN ISO 13485:2016 , Quality Management System for Medical Devices

ULTICLEAN PROPHYLAXIS POWDER STANDARD

“ Remove stains but protect hard tooth substance! “

Figure 2: left: EMS Air-Flow Classic Comfort powder with a given mean particle size of 40μm. right: Ulticlean Prophylaxis Powder Standard with a mean particle size of 43μm

EMS

BA Ulticlean Prophylaxis Powder

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ULTICLEAN PROPHYLAXIS POWDER STANDARD

The Patent Pending New Development for Sub- & Supragingival Prophylaxis Results Our aim was to develop a new prophylaxis powder, which can be used in the sub- and supragingival areas. It also needed to provide excellent cleaning performance with minimal time expenditure as well as to be gentle on the patient’s teeth. To have a prophylaxis with these features, several essential factors play a role: the particle’s abrasiveness, optimum particle size distribution, geometry of the particles, cleaning effect, polishing effect, and smooth effect. Characteristics of Monosaccharide Tagatose: The special monosaccharide tagatose is non-cariogenic, very tooth friendly as well as it has a very low glycemic index (GI), making it ideal for diabetics. It shows also a high compatibility and does not act as a laxative when ingested. Tagatose is still not hygroscopic and shows an excellent spraying behaviour, there is no caking of the powder in the blasting unit. Tagatose has a pleasant sweet taste and, unlike glycine, does not have a sensitising effect on some patients. Abrasiveness: The newly developed tagatose-based BA Ulticlean Prophylaxis Powder PERIO PLUS was compared with various known sodium bicarbonate, glycine, erythritol and trehalose powders on the market. Sodium bicarbonate-based powders, having a mean grain size of 40 μm, are the most widely used in tooth enamel cleaning. Sodium hydrogen carbonate powder are not suitable for cleaning sensitive surfaces due to their high abrasiveness. Tooth surfaces, tooth necks or in the subgingival area. The innovative Ulticlean Prophylaxis Powder PERIO PLUS, with a medium grain size of 15 μm, is less abrasive than conventional powders. As shown below, it also has a superb cleaning and polishing effect. The abrasiveness of Ulticlean Prophylaxis Powder PERIO PLUS has been compared with commercially available powders (Air- Flow Classic Comfort, Air-Flow Soft, Air- Flow Plus, Air-Flow Perio from EMS Electro Medical Systems SA, Switzerland; Lunos Gentle Clean, Lunos Perio Combi from Dürr Dental AG / Orochemie GmbH + Co.KG, Germany). The tests were carried out with a commercially available powder jet device. (Airflow handy 2+, EMS Electro Medical Systems SA, Switzerland). Polyetheretherketone PEEK, a high-performance polymer used in dental prosthetics, was used to simulate the tooth surface. The nozzle of the air polishing device was placed at a distance of 2mm above the polymer surface and the powder jet was activated for 30 seconds at a blast pressure of 4.0 bar. The depth of the area of the polymer surface eroded by the powder served as a measure of its abrasiveness. To account for statistical variations, each experiment was repeated five times. The value of 10 corresponds to the abrasiveness of sodium bicarbonate with an average particle size of 40 μm. A lower numerical value corresponds to a lower abrasiveness.

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ULTICLEAN PROPHYLAXIS POWDER PERIO PLUS

As can be seen in Figure 3, the newly developed Ulticlean Prophylaxis Powder PERIO PLUS shows a very low abrasiveness towards the tooth surface. This gentle property makes it particularly attractive for use on tooth surfaces and tooth necks. As Figure 3 shows, there is a correlation between grain size and abrasiveness. The smaller the grain size, the gentler the powder. In addition, the choice of material used plays a role. For example, the glycine-based powder with a mean particle size of 65 μm has a lower abrasiveness than the sodium hydrogen base powder with a mean particle size of 40 μm. Material properties such as hardness as well as the particle geometry play a major role. Sodium hydrogen base is the hardest and most abrasive powder compared to a Mohs hardness of 2.5-3, followed by glycine with a Mohs hardness of 2. The sugars trehalose, tagatose, and alcohol erythritol all have a Mohs hardness of <2.

Removal of tooth substance Removal of tooth substance

bad

Figure 3: Comparison of different prophylactic powders: EMS Classic Powder, with a mean particle size of 40μm, was normalised to a numerical value of 10. Both the particle size and material properties of the various powders play a role in their abrasiveness

good

EMS Classic NaHCO3 40µm

EMS Soft Glycin 65µm

EMS Perio Glycin 25µm

Lunos Gentle Clean Trehalose 65µm

Lunos Perio Combi Trehalose 30µm

EMS Plus Erythritol 15 µm

BA Ulticlean Prophy Perio Plus Tagatose 15µm

Grain Size and Particle Geometry: The mean particle size of the prophylaxis powder plays a role in the abrasiveness of the product. Ulticlean Prophylaxis Powder PERIO PLUS was adjusted to a mean particle size of 15μm because of its low abrasiveness towards enamel and sensitive dentine. Ulticlean Prophylaxis Powder PERIO PLUS has a volume average particle size of d (50) = 15 μm. The values d (10) = 8 μm, d (90) = 33 μm describe the very narrow width of the volume-related particle size distribution. One of the powders used for comparison is the sugar alcohol erythritol (EMS Airflow Plus) with a particle size of 15μm. This powder shows a higher abrasiveness than Ulticlean Prophylaxis Powder PERIO PLUS with a grain size of 15μm. In addition, these two powders were also examined with a light microscope (see Figure 3). It was found that the erythritol-based powder EMS Plus (Figure 3, above) shows a more inhomogeneous composition with partially sharp- edged, pointed particles compared to the tagatose-based Ulticlean Prophylaxis Powder PERIO PLUS (Figure 3, right). Furthermore, Ulticlean Prophylaxis Powder PERIO PLUS study shows a more amorphous, rounder particle structure than the erythritol-based EMS Airflow Plus Powder (see Figure 3). This characteristic explains, among other things, the less abrasive behaviour of Ulticlean Prophylaxis Powder PERIO PLUS. This is because the special particle formation breaks up the powder particles on impact and then distributes their kinetic energy directly to the tooth surface. As a result, the excellent cleaning effect can be explained very well despite the low abrasiveness.

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ULTICLEAN PROPHYLAXIS POWDER PERIO PLUS

Figure 4: Volume-related particle size distribution (d (50) = 15 μm, d (10) = 8 μm, d (90) = 33 μm) of the developed Ulticlean Prophylaxis Powder PERIO PLUS.

Cleaning Effect: The cleaning effect of Ulticlean Prophylaxis Powder PERIO PLUS was tested in comparison to commercially available powders. For this purpose, the removal of dental plaque was simulated. The tests were carried out with a commercially available powder jet device. (Airflow handy 2+, EMS Electro Medical Systems SA, Switzerland). Ulticlean Prophylaxis Powder PERIO PLUS and comparison powders were blasted onto a coated PEEK plate. The areas (1 cm x 1 cm) were treated with the respective powders until the coating was completely removed from the surface. The time required for cleaning the area was measured. To account for statistical variations, each experiment was repeated 10 times. The cleaning effect was assigned the value 10 to the sodium hydrogen carbonate powder with a particle diameter of 40 μm, as in the previous experiment. The calculated times were normalised to the value 10. The higher the score, the better the cleaning performance (see Figure 4). With a value of 17, Ulticlean Prophylaxis Powder PERIO PLUS showed the fastest and most effective cleaning performance compared to the tested powder!

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ULTICLEAN PROPHYLAXIS POWDER PERIO PLUS

Figure 5: left: EMS AIR-FLOW Plus based on erythritol with a mean particle size of 15μm. right: the based Ulticlean Prophylaxis Powder PERIO PLUS based on tagatose with a mean particle size of 15μm.

EMS

BA Ulticlean Prophylaxis Powder

Cleaning Speed

fast

10 12 14 16 18

0 2 4 6 8

slow

BA Ulticlean Prophy Perio EMS Plus Erythritol 15 µm Plus Tagatose 15µm

Lunos Perio Combi Trehalose 30µm

EMS Classic NaHCO3 40µm

EMS Soft Glycin 65µm

EMS Perio Glycin 25µm

Lunos Gentle Clean Trehalose 65µm

Figure 6: Comparison of the cleaning effect of different powders. Ulticlean Prophylaxis Powder PERIO PLUS shows the fastest and most effective cleaning performance.

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ULTICLEAN PROPHYLAXIS POWDER PERIO PLUS

Polishing Effect: To assess the polishing effect, the optics and haptics of the surface after the radiation of the coated area were also evaluated (see cleaning effect). Again, the value 10 was assigned to the sodium bicarbonate powder having a particle diameter of 40 μm for better comparability. The smaller the point value, the smoother and more cleaning of the surface. (see Figure 5). Ulticlean Prophylaxis Powder PERIO PLUS shows outstanding cleaning and polishing performance with very low abrasiveness. The glycine powder EMS Perio with a particle diameter of 25 μm and the erythritol powder EMS Plus with a particle diameter of 15 μm showed a similar behaviour in the polishing of the surface. However, these cut in the evaluation of cleaning time and abrasiveness compared to the BA Ulticlean Prophylaxis Powder PERIO PLUS. This polishing effect makes a final polish of the tooth after the irradiation superfluous. This also represents a considerable time savings for the dentist.

Polish Effect

bad

0 2 4 6 8 10

good

EMS Plus Erythritol 15 µm Plus Tagatose 15µm BA Ulticlean Prophy Perio

EMS Classic NaHCO3 40µm

EMS Soft Glycin 65µm

EMS Perio Glycin 25µm

Lunos Gentle Clean Trehalose 65µm

Lunos Perio Combi Trehalose 30µm

Figure 6: Comparison of the polishing effect of different powders. The smaller the value, the smoother the surface or the better the polishing effect.

Smooth Effect: In order to demonstrate the unique cleaning and polishing performance of the Ulticlean Prophylaxis Powder PERIO PLUS, our team developed the “smooth effect” especially for this purpose: This establishes a ratio between the fast and gentle cleaning and polishing performance of the Ulticlean Prophylaxis Powder PERIO PLUS sof the tested powders. For this purpose, the reciprocal value of the ratio of the polishing effect to the cleaning effect was determined. The higher the value, the greater the smooth effect, which indicates the combination of the cleaning and polishing effect of the respective powders tested. Again, Ulticlean Prophylaxis Powder PERIO PLUS with the highest value of 8.50 outperforms the other powders tested (see Figure 6).

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ULTICLEAN PROPHYLAXIS POWDER PERIO PLUS

Polish Effect

good

0,00 1,00 2,00 3,00 4,00 5,00 6,00 7,00 8,00 9,00

8,50

7,50

4,67

2,60

1,56

1,63

1,00

bad

BA Ulticlean Prophy Perio Plus Tagatose 15µm

EMS Classic NaHCO3 40µm

EMS Soft Glycin 65µm

EMS Perio Glycin 25µm

Lunos Gentle Clean Trehalose 65µm

Lunos Perio Combi Trehalose 30µm

EMS Plus Erythritol 15 µm

Figure 7: Comparison of the smooth effect of different powders. Prophylaxis Powder PERIO PLUS performs best with a value of 8.50 compared to the other powders tested.

Tabular Comparison of Ulticlean Prophylaxis Powders PERIO PLUS and EMS PLUS: Ulticlean Prophylaxis Powder PERIO PLUS shows lower abrasiveness, better cleaning performance and cleaning speed, as well as an excellent smooth effect compared to the competitor product EMS PLUS.

heavy deposit s

light deposit s

application on denti n

application on implants

Powder type abrasiveness

Perio PLUS (Tagatose)

+ + +

– – –

+ + +

EMS Plu s (Erythrit)

+ +

– – –

+ +

+ + +

powde r

supragingival

subgingival

cl eaning speed polish smooth eect

Perio PLUS (Tagatose)

+ + +

EMS Plu s (Erythrit)

+ + +

+ +

+ + +

Summary We have succeeded in developing an innovative prophylaxis powder, which is ideally suited for the sub- and supragingival areas. It also has a very low abrasiveness as well as excellent cleaning and polishing performance. This innovative development was therefore patented.

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