StaiNo® INTERDENTAL BRUSHES
CLINICAL EVALUATION - STAIN REMOVAL AND ABRASIVITY
Stains in the embrasures and interproximal spaces between teeth can be difficult to remove using standard toothbrushes and standard interdental brushes. A new interdental brush with a polishing agent incorporated in its nylon bristles, StaiNo®, has recently been introduced. A four-week clinical study was conducted by this author at UMDNJ – New Jersey Dental School to evaluate the efficacy of stain removal using the StaiNo® brushes vs. standard nylon interdental brushes. Fifty subjects participated in this randomized double blind, stratified, two-treatment clinical trial.
PROTOCOL
1. Subjects were chosen who had at least three cleansable anterior interproximal spaces (six proximal tooth surfaces). They were balanced into two groups, having “moderate” or “heavy” stain on their teeth.
2. The brushing regimen was as follows: Subjects were instructed to brush interproximally without a dentifrice twice per day for the duration of the study, after first brushing with their usual toothbrush and toothpaste. Used brushes were discarded and a new brush was used each day. Twenty-five subjects used the StaiNo® brush and twenty-five subjects used the control nylon brush.
3. A modified Lobene Stain Index (Lobene, JADA, 1968,V.77, pp.849-55) was used to determine the area and intensity of interproximal stain after 2 weeks and 4 weeks of use. Digital imaging was used to document the amount of stain present.
RESULTS
1. The StaiNo® brush removed stain significantly better than the control.
2. The StaiNo® brush removed 21% of the stain after 2 weeks and 34% of the stain after 4 weeks.
3. There were no adverse reactions found by direct oral tissue examination for the duration of the study, nor were there any adverse reactions reported by the subjects.
4. The StaiNo® brush removed stain similarly (at the same rate) for both moderate and heavy stains.
CONCLUSION
The results of this study show that the StaiNo® interdental brush is significantly more effective at removing stain from the interproximal areas of anterior teeth than the standard nylon control brush.
SEM Micrograph (500X) Of StaiNo Nylon Brush
Bristle Containing Abrasive
Polishing Particles.
Studies conducted at:
New Jersey Dental School (UMDNJ)
110 Bergen Street
Newark, New Jersey 07103
April 29, 2002
by Marc A. Rosenblum, Ph.D., D.M.D.
Associate Professor of Dentistry
Department of General Dentistry and Biomaterials
StaiNo® INTERDENTAL BRUSHES
LABORATORY EVALUATION - STAIN REMOVAL AND ABRASIVITY
OBJECTIVE
The primary objective of this study was to compare the stain removing ability of nylon interdental brushes containing aluminum oxide (alumina) - StaiNo® brushes - to standard nylon interproximal brushes without alumina.
The secondary objective of this study was to evaluate the effect of the StaiNo® interdental brushes containing alumina on natural tooth enamel: the degree of scratching (if any) as compared to standard nylon interdental brushes.
RESULTS
A. Stain Removal
Visual examination revealed that the StaiNo® brush removes coffee and tea stains at a rate about double that of the control brush. For example, the amount of stain removal achieved by the StaiNo® brush at 100 strokes was about the same as the standard brush at 200 strokes. This result was consistent for all the stained teeth evaluated. Photographs (Figures 2a, 2b and 2c) showing the results of a tea stain are typical of the findings for all the teeth tested.
Baseline Standard StaiNo Standard StaiNo
Figure 2a 100 Brush Strokes 200 Brush Strokes
Figure 2b Figure 2c
B. Scratching of Tooth Surface by the Brushes
There is no evidence of scratching produced by the StaiNo® brush or the standard brush after 200 brush strokes when observed using a stereomicroscope at 10x and 25x magnification.
SEM evaluation at 1000x magnification revealed small scratches on the surface of the natural tooth enamel resulting from the alumina containing brush. These scratches were approximately the same size as those produced using a fine abrasive prophylaxis paste (See Figure 3b).
Neither the StaiNo® brush nor the standard brush produced scratches on tooth enamel that were visible with the unaided eye or at 25x using the stereomicroscope.
CONCLUSIONS
There is an observable difference between a the new StaiNo® interdental brush and a standard control nylon interdental brush in the ability for stain removal from extracted natural teeth. The rate of stain removal of the StaiNo® brush is approximately twice that of the standard nylon brush.
The new StaiNo® brush produced small scratches on the surface of the natural tooth enamel. These scratches were approximately the same size as those produced using a fine abrasive prophylaxis paste. Neither the StaiNo® brush nor the standard brush produced scratches on tooth enamel that were visible with the unaided eye or at 25x using the stereomicroscope.
StaiNo® DENTAL FLOSS
LABORATORY EVALUATION - STAIN REMOVAL AND ABRASIVITY
OBJECTIVE
The primary objective of this study was to determine the stain removing ability of StaiNo® dental floss.
The secondary objective was to evaluate the effect of the StaiNo® dental floss on natural tooth enamel (safety evaluation).
RESULTS
Stain Removal
The Minolta Colorometer measurements show a significant decrease in the amount of stain on the test bovine tooth enamel surfaces when brushed for 10,000 reciprocal strokes. The amount of stain removal was dependent on the level of initial stain: lighter stains were removed more significantly and sooner than heavier stains.
Safety
Examination of human enamel under the SEM (Scanning Electron Microscope) at 1000X magnification shows no adverse changes in surface condition (i.e., no scratches) after 10,000 brush strokes. The brushes do not abrade human tooth enamel to any measurable extent.
1. Microscopy of the Floss
SEM Photomicrographs of the floss are shown in SEM 1 and SEM 2. The abrasive particles can be clearly seen at high magnification.
SEM 1
StaiNo Dental Floss 25x
SEM 2
StaiNo Dental Floss 1000x
2. Stain Removal
The data of the Minolta Colorometer for the average of all samples tested are shown in the table below. There was a significant progressive lightening of the tooth as compared to the baseline (unflossed) state as shown by the increase in the E values.
# of Reciprocal
Flossing Strokes |
Δ E |
| 20 |
10.34 |
| 50 |
17.17 |
| 100 |
23.76 |
| 200 |
30.76 |
The digital images of the sequence of flossing stain removal for a representative sample are shown in SEM 3 and SEM 4.
3. Safety
No adverse effect of the floss on natural tooth enamel was determined using the SEM at 25 and 100x. No scratches were seen on the enamel surfaces after 200 reciprocal strokes. The results of a representative sample are shown in Colorometer 1 and Colorometer 2.
StaiNo® TOOTHBRUSHES
LABORATORY EVALUATION
OBJECTIVE
The primary objective of this study was to determine the stain removing ability of StaiNo® toothbrushes.
The secondary objective was to evaluate the effect of the brush bristles on natural tooth enamel (safety evaluation).
MATERIALS AND METHODS
This was a standard laboratory evaluation performed on extracted stain bovine teeth and on extracted human teeth.
Twelve StaiNo® toothbrushes were supplied. All brushes had the same bristle configuration, shape, size and length. Eight (8) brushes were used for the stain removal evaluation and four (4) brushes were used for the safety evaluation.
Eight (8) flat bovine enamel samples, which were stained according to the method described by Schemehorn, “In Vitro Removal of Stain with Dentifrices”, JDR (1982), were used for the stain removing evaluation of the study. Four (4) extracted human central incisors with broad, flat unrestored facial surfaces were used for the safety evaluation of the study.
The toothbrushing machine is modeled after an ADA standard design. The weight on each toothbrush head is 256 grams, and a speed of 180 reciprocal stroke cycles per minute was used. Water was used in all testing as a medium; no dentifrice was used in this evaluation.
All samples were evaluated at specific intervals: after 500, 1000, 2000, 5000 and 10000 brushing cycles. At each interval, the samples were visually evaluated for scratches and stain removal, and were also evaluated at 10X and 20X under a stereomicroscope. A Mitutoyo Surftest 401 Profilometer was utilized to determine surface roughness of the bovine and human enamel samples at each test interval. Digital images were taken using a Nikon Coolpix 800 digital camera to record any visual changes. A Minolta Chromometer CR-221 with a 1 mm diameter limited area attachment was used to quantify color changes during the progressive removal of the stain from each sample.
For the safety evaluation, one-half of each extracted natural tooth was protected with adhesive tape during the brushing in order to compare brushed vs. non-brushed areas for each tooth. The teeth were observed under a Hitachi Scanning Electron Microscope (SEM) for evidence of scratches produced by the brushes.
CONCLUSIONS
Stain Removal
The Minolta Colorimeter measurements show a significant decrease in the amount of stain on the test bovine tooth enamel surfaces when brushed for 10,000 reciprocal strokes. The amount of stain removal was dependent on the level of initial stain: lighter stains were removed more significantly and sooner than heavier stains.
Safety
Examination of human enamel under the SEM (Scanning Electron Microscope) at 1000X magnification shows no adverse changes in surface condition (i.e., no scratches) after 10,000 brush strokes. The brushes do not abrade human tooth enamel to any measurable extent.
Studies conducted at:
New Jersey Dental School (UMDNJ)
110 Bergen Street
Newark, New Jersey 07103
July 31, 2003
by Marc A. Rosenblum, Ph.D., D.M.D.
Associate Professor of Dentistry
Department of General Dentistry and Biomaterials
StaiNo® TOOTH STAIN ERASER
LABORATORY EVALUATION - STAIN REMOVAL AND ABRASIVITY
OBJECTIVE
The primary objective of this laboratory study was to evaluate the potential of using the StaiNo® Tooth Stain Eraser product to effectively remove stain from natural tooth enamel.
The secondary objective of this study was to evaluate the abrasivity of the product relating to scratching or other deleterious effects on tooth enamel.
RESULTS
Stain Removal
On light coffee, tea, or tobacco stain.
Visual examination and Colorimetric determinations showed that regardless of the type of stain, removal of the stain from the extracted teeth was generally accomplished after 30 hand strokes with the 400 grit StaiNo® Tooth Stain Remover product.
On heavy tobacco stain with calculus
In general, for total stain removal using the 400 grit StaiNo® Tooth Stain Remover 200 strokes were required. It should be noted that very heavy stains were generally associated with calculus build-up on the teeth. The degree of difficulty of removal of the stain was compounded by the removal of the underlying calculus.
Photographs of the stain removal of some heavily stained lower incisors are shown in figures 1-4.
Figure 1 Figure 2
Initial heavy tobacco stain Removed stain with StaiNo instrument
Figure 3 Figure 4
Sample #2 - Initial stain Sample #2, Stain removed with StaiNo instrument
Scratching of Tooth Surface by the StaiNo® Tooth Stain Eraser
Using the stereomicroscope, it was observed that the enamel surface rubbed with the 400 grit Tooth Stain Eraser had no visible scratches, and remained shiny in appearance.
Using the scanning electron microscope at 400 to 1000X, it was determined that the 400 grit StaiNo® instrument created scratches which were generally less than 5 microns in with. See Figure 5.
Figure 5 - 
Scratches produced
by 400
grit StaiNo®
Tooth Stain
Eraser SEM
magnification
500X
CONCLUSIONS
1. The 400 grit StaiNo® Tooth Stain Eraser is capable of removing light and heavy stains of coffee, tea, and tobacco.
2. The 400 grit StaiNo® Tooth Stain Eraser creates no visible differences in the enamel surface after rubbing, and the surface remains shiny. Microscopically, it appears that this instrument creates scratches in the enamel surface which are less than 5 microns in width. In the investigator’s opinion these small scratches created may be remineralized by natural salivary constituents and by using remineralizing over-thecounter toothpaste formulation.
Studies conducted at:
New Jersey Dental School (UMDNJ)
110 Bergen Street
Newark, New Jersey 07103
April 29, 2002
by Marc A. Rosenblum, Ph.D., D.M.D.
Associate Professor of Dentistry
Department of General Dentistry and Biomaterials
