Gentleness
Transcription
Gentleness
The Science Behind Sonicare oothbrush Notes from Dr. Joerg Strate Vice President, Philips Oral Healthcare, Clinical & Scientific Affairs Philips Sonicare has redefined personal oral hygiene once again When we decide to launch a new edition of the clinical proof brochure, the document in your hands, you know we must have a significant reason to do so. Launching two new products and introducing breakthrough technology that’s likely to change our perspective on interdental cleaning are indeed significant accomplishments. The clinical and scientific research por tfolio summarized in this document provides objective and relevant information about our products, and insights into the way we work. Our clinical credibility and commitment to providing patients and dental professionals with the most advanced solutions for home oral healthcare have resulted in global recognition and professional recommendation of Philips Sonicare products. True innovation at Philips Sonicare follows a simple paradigm that integrates the latest scientific knowledge with an in-depth understanding of today’s oral healthcare needs. Adhering to these principles frequently results in solutions and technologies that are ahead of their time, and subsequently lead the industry. The original Sonicare technology was exactly that type of industry-leading innovation — it defined a new standard for power toothbrushes. Recently, Sonicare For Kids established a unique solution for the specific oral healthcare needs of children. Now the new Sonicare DiamondClean takes our ambition to the next level with the best clinical performance of any Sonicare to date, thanks to its unique brush head and ergonomic handle design. The requirements for our latest innovation, the entirely new Philips Sonicare AirFloss, could not be matched by existing concepts — we had to invent them. The result is a unique device that impresses equally with its convenience of use and its clinical efficacy, which could not exist without the unprecedented AirFloss microburst technology invented by Philips engineers. When you read the following pages, I hope you will agree with me that Sonicare DiamondClean and AirFloss represent a significant next step toward even better, more intuitive solutions for daily oral hygiene — exactly what Philips Sonicare is all about. Sonicare DiamondClean Gentleness in vitro study* In vitro assessment of dentin wear resulting from the use of the Philips Sonicare DiamondClean power toothbrush Moore M, Putt M, Jain V, de Jager M. Data on file, 2010 Objective To evaluate dentin wear associated with the use of Philips Sonicare DiamondClean standard and compact brush heads compared to a manual toothbrush using simulated clinical conditions. Methodology Twenty-four human dentin slices with a surface of 3x10 mm were embedded in temporary crown and bridge material and polished to render a smooth surface as starting condition. Samples were brushed either with Sonicare DiamondClean standard and compact brush heads using externally powered Sonicare handles at 100 grams or with an ADA reference manual toothbrush at 250 grams brushing load. These brushing loads represent clinical use conditions. All specimens were brushed using toothpaste slurry for a period representing six months (3,000 strokes) of clinical brushing. Dentin wear was determined before and after brushing using surface profilometry to establish the mean depth of induced surface wear from toothbrushing. Results Both Sonicare DiamondClean standard and compact brush heads resulted in significantly less dentin abrasion than the manual toothbrush (p<0.05). There was no significant difference between Sonicare DiamondClean standard and compact brush heads. Conclusion In this in vitro study, the Sonicare DiamondClean standard and compact brush heads were found to cause about 50% less dentin wear than a manual toothbrush. Dentin Wear 60 55 50 Sonicare DiamondClean Compact 40 Wear (µm) 30 28 Manual Toothbrush 27 20 10 0 Sonicare DiamondClean Standard Sonicare DiamondClean Compact Treatment *Results will var y with actual use 52 Sonicare DiamondClean Standard Manual Toothbrush Sonicare Sensitive Brush Head Gentleness in vitro study* In vitro assessments of dentin wear resulting from the use of the Sonicare sensitive brush head Hix J, de Jager M, Contracted Dental Research Laboratory. Data on file, 2011 Objective To evaluate dentin wear associated with the use of Sonicare sensitive and ProResults brush heads compared to a manual toothbrush using simulated clinical conditions. Methodology Twenty-four human dentin slices with a surface of 3x10 mm were embedded in temporary crown and bridge material and polished to render a smooth surface as starting condition. Samples were brushed with a sensitive or a ProResults brush head using externally powered Sonicare handles at 100 grams or brushed with an ADA reference manual toothbrush at 250 grams brushing load. (These brushing loads represent clinical use conditions.) All specimens were brushed using toothpaste slurry for a period representing six months (3,000 strokes) of clinical brushing. Dentin wear was determined before and after brushing using surface profilometry to establish the mean depth of induced surface wear from toothbrushing. Results The sensitive brush head resulted in significantly less dentin abrasion than the manual toothbrush (p<0.05). Conclusion In this in vitro study, the sensitive brush head was found to cause about 56% less dentin abrasion than a manual toothbrush. Dentin Wear 50 44 40 Wear (µm) 30 ProResults Standard Sensitive Standard 27 Manual Toothbrush 25 20 10 0 Sensitive Standard ProResults Standard Manual Toothbrush Treatment *Results will var y with actual use 53 Sonicare FlexCare / FlexCare+ Gentleness in vitro study* In vitro effect of power toothbrushes on or thodontic bracket bond strength de Jager M, Nelson R, Schmitt P, Moore M, Putt M, Kunzelmann KH, Nyama I, Garcia-Godoy F, Garcia-Godoy C. In vitro assessment of toothbrushing wear on natural and restorative materials. Compend Contin Educ Dent. 2007; 28 (suppl 1):42-50) Objective To evaluate the effect of two new power toothbrushes and a manual toothbrush on the bond strength of orthodontic brackets bonded to human enamel using simulated clinical conditions. Methodology Orthodontic brackets were bonded to 36 extracted teeth and exposed to Sonicare FlexCare power toothbrush or Oral-B P-35 Soft® manual toothbrush for the equivalent of a two-year exposure to brushing in the presence of a toothpaste slurry. After brushing, the force needed to debond the orthodontic brackets from the teeth was measured. Results There were no statistically significant differences in bracket debonding strength between any of the treatments (p>0.05). Conclusion This study demonstrated that the Sonicare FlexCare is safe to use for patients with orthodontic brackets compared to a manual toothbrush. Bracket Debonding Force 98 100 78 Manual Toothbrush 75 Force (N) 50 25 0 (p>0.05) Treatment *Results will var y with actual use 54 Sonicare FlexCare Sonicare FlexCare / FlexCare+ Gentleness in vitro study* In vitro assessment of dentin wear resulting from the use of oral hygiene devices de Jager M, Nelson R, Schmitt P, Moore M, Putt M, Kunzelmann KH, Nyama I, Garcia-Godoy F, Garcia-Godoy C. In vitro assessment of toothbrushing wear on natural and restorative materials. Compend Contin Educ Dent. 2007; 28 (suppl 1):42-50) Objective To evaluate dentin wear associated with the use of the Sonicare FlexCare power toothbrush compared to Oral-B Triumph® and a manual toothbrush using simulated clinical conditions. Methodology Forty human dentin slices with a surface of 3x10 mm were embedded in temporary crown and bridge material and polished to render a smooth surface as starting condition. Samples were either brushed with Sonicare FlexCare at 90 grams, Oral-B Triumph at 150 grams or Oral-B P-35 Soft® manual toothbrush at 250 grams. These brushing loads are representing clinical use conditions. All specimens were brushed using a toothpaste slurry based on Crest Cool Mint Gel for a period representing two years of clinical brushing. Dentin wear was determined before and after brushing using 3D laser triangulation measurements to establish induced wear from toothbrushing. Results Sonicare FlexCare resulted in significantly less dentin wear than both the manual toothbrush (p<0.05) and the Oral-B Triumph (p<0.05). There was no significant difference between the manual and Oral-B Triumph brush. Conclusion In this in vitro study, Sonicare FlexCare was found to cause 50% less dentin wear than a manual toothbrush and a rotating-oscillating power toothbrush. Dentin Wear 100 81 80 Wear (µm) Sonicare FlexCare 77 Manual Toothbrush 60 40 Oral-B Triumph® 38 20 0 Sonicare FlexCare 90g Oral-B Triumph 150g Manual 250g Treatment (brush and brushing load) *Results will var y with actual use 55 Sonicare FlexCare / FlexCare+ Gentleness in vitro study* In vitro assessment of the effect of a manual and Sonicare FlexCare toothbrush on gloss and roughness of dental materials de Jager M, Nelson R, Schmitt P, Moore M, Putt M, Kunzelmann KH, Nyama I, Garcia-Godoy F, Garcia-Godoy C. In vitro assessment of toothbrushing wear on natural and restorative materials. Compend Contin Educ Dent. 2007; 28 (suppl 1):42-50) Objective To evaluate the effect on wear of dental materials of the Sonicare FlexCare power toothbrush and a manual toothbrush using simulated clinical conditions. Methodology Four different materials were investigated: the restorative composite materials Solidex and EsthetX, the implant material Titanium, and natural bovine enamel. For each material, 32 samples were embedded in acrylic mounts and polished to render a smooth surface as starting condition. Samples were either brushed with Sonicare FlexCare at 100 and 150 grams, or Oral-B P-35 Soft® manual toothbrush at 150 grams and 250 grams brushing load. All specimens were assessed after 3,000 and 12,000 brushing strokes, representing six months and two years of brushing, respectively, while using a toothpaste slurry based on Crest® Cool Mint Gel. Surface wear was determined before and after brushing using gloss meter and profilometry. Results In general, when differences were noted, they favored the Sonicare FlexCare over the manual toothbrush at clinically observed brushing forces (100 and 250 grams, respectively). For abrasion of Solidex, Sonicare FlexCare at 100 and 150 grams, and the manual brush at 150 grams all showed significantly less abrasion than the manual brush at 250 grams. For gloss of Solidex, Sonicare FlexCare at 100 grams, and the manual brush at 150 grams both retained significantly more gloss than the manual brush at 250 grams. For EsthetX and Titanium, no significant differences were observed. For gloss of bovine enamel, FlexCare at 100 grams retained significantly more gloss than the manual brush at 250g. Conclusion This study demonstrated that the Sonicare FlexCare is gentle for use on dental materials compared to a manual toothbrush for up to two years of simulated brushing with toothpaste. *Results will var y with actual use 56 Sonicare FlexCare / FlexCare+ Solidex EsthetX Enamel Titanium 0.7 Ra (mm) Sonicare FlexCare – 100 g 0.6 0.5 Manual Toothbrush – 250 g 0.4 0.3 0.2 3000 12000 Baseline 3000 12000 Baseline 3000 12000 Baseline 3000 12000 Baseline 0.1 0 Material and number of strokes Solidex EsthetX Enamel 120 Sonicare FlexCare – 100 g 100 Manual Toothbrush – 250 g 80 60 40 20 12000 3000 Baseline 12000 3000 Baseline 12000 3000 0 Baseline Gloss (GU) Material and number of strokes 57 Sonicare FlexCare+ Gentleness in vivo study Comparison of Sonicare FlexCare power toothbrush and a manual toothbrush on dentin hypersensitivity Frederick C, DeLaurenti M, Olson M, Jinling W, Jenkins J, Strate J. Data on file, 2009 58 Objective To investigate the effects of the Sonicare FlexCare power toothbrush and Oral-B P-40® manual toothbrush on dentin sensitivity. Methodology Forty-five healthy subjects, aged 24-63 years were enrolled in an IRB-approved randomized, parallel-design study to assess dentin sensitivity after four and eight weeks of use with Sonicare FlexCare or Oral-B P-40 manual toothbrush. In order to qualify for enrollment, subjects were required to have dentin sensitivity on the facial surface of at least one tooth and up to two teeth in different quadrants at screening and baseline on the same teeth. Sensitivity was assessed using evaporative and tactile stimulation and defined as experiencing discomfort using a Visual Analogue Scale (VAS) of 0–100 mm. Subjects returned to the research center at four and eight weeks for repeat assessments on sensitive teeth. At two and six weeks, subjects were contacted by phone for compliance checks and to answer study-related questions. The primary endpoint was the reduction in dentin sensitivity following eight weeks of product use. Results Forty-three subjects completed the study. The table provides a summary of the Global, Evaporative and Tactile VAS sensitivity mean scores measured at each of the three study examination visits. There was a statistically significant difference in the longitudinal VAS assessments of sensitivity for FlexCare post four and eight weeks of product use. Similar differences were observed for the manual toothbrush users except the evaporative stimulus scores, which were not significantly different post four weeks. Although no statistically significant difference was observed between groups when sensitivity was assessed after tactile stimulation at either time point, there was a statistically significant difference between FlexCare and a manual toothbrush following four weeks (p=0.0578) and eight weeks (p=0.0379) of product use after evaporative stimulation. Conclusion Philips Sonicare FlexCare showed significant reduction in pain associated with dentin hypersensitivity compared to a manual toothbrush following eight weeks of product use. Sonicare FlexCare+ VAS Scores (Mean) Examinations Treatments Global Evaporative Tactile FlexCare 56.9 60.86 NA Manual 56.41 57.82 NA FlexCare NA 60.24 53.57 Manual NA 58.91 54.98 FlexCare 45.33 48.1 41.67 Manual 50.09 57.36 36.57 FlexCare 38.1 40.98 33.52 Manual 45.64 51.27 34.57 Screening Baseline 4 Week 8 Week Evaporative Stimulus 80 70 60 60.24 58.91 VAS Score 57.36 48.1 50 51.27 40.98 40 Sonicare FlexCare 30 Manual Toothbrush 20 10 0 Baseline Post 4 Weeks (p=0.0578) Post 8 Weeks (p=0.0379) Global Assessment of Sensitivity 80 70 60 56.9 56.41 50 VAS Score 45.33 50.09 45.64 38.1 40 30 Sonicare FlexCare Manual Toothbrush 20 10 0 Baseline Post 4 Weeks (p=0.0578) Post 8 Weeks (p=0.0379) 59 Sonicare Elite Gentleness in vivo study Changes in localized gingival recession with manual and power toothbrushes McCracken GI, Heasman L, Stacey F, Swan M, Steen N, de Jager M, Heasman PA. The impact of powered and manual toothbrushing on incipient gingival recession. J Clin Periodontol 2009; 36: 950–957. doi: 10.1111/j.1600-051X.2009.01472.x 60 Objective To compare long-term clinical effects of using manual and power toothbrushes upon sites of localized gingival recession. Methodology A longitudinal, single-blind, randomized, parallel group clinical trial was conducted over 12 months to compare the effects of one manual toothbrush (Oral-B P-35®) and one power toothbrush (Sonicare Elite) upon the progression of pre-existing lesions of localized gingival recession. Full-mouth plaque index (PI), probing depths, bleeding on probing were recorded at baseline and 12 months. Maximum height of recession (h_max), width of keratinized gingivae, clinical attachment level, probing depth, bleeding on probing and Turesky’s Quigley-Hein Plaque Index were recorded for target sites of localized gingival recession at baseline, three, six, nine and twelve months. Results Sixty patients were recruited and randomized to two groups with fifty-two (26 per group) attending the final visit at month 12. No differences at target sites were detected for maximum height of recession, width of keratinized gingivae, clinical attachment level, pocket depth, bleeding on probing or Turesky’s Quigley-Hein Plaque Index. No differences were detected between groups for full-mouth plaque index, pocket depth or bleeding on probing at baseline and month 12. Conclusion This study demonstrated that there was no deterioration or progression of localized gingival recession in subjects using the Sonicare Elite power toothbrush compared to a manual toothbrush over 12 months. Sonicare Elite 2.5 Sonicare Elite Manual Toothbrush 2 Error bars show 95.0% CI of mean h_max 1.5 1 0.5 0 1 2 3 4 5 6 Visit Mean Visit 1 2 3 4 5 6 Period Screening Baseline Month 3 Month 6 Month 9 Month 12 Elite 1.91 1.89 1.75 1.7 1.76 1.73 Manual Toothbrush 1.83 1.85 1.83 1.89 1.79 1.82 Visit 1 2 3 4 5 6 Period Screening Baseline Month 3 Month 6 Month 9 Month 12 Elite 0.88 0.894 0.836 0.749 0.881 0.89 Manual Toothbrush 0.802 0.784 0.813 0.705 0.78 0.741 Standard Deviation 61
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