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A profilometry-based dentifrice abrasion method for V8 brushing machines part


II: Comparison of RDA-PE and radiotracer RDA measures

Article · January 2015

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A Profilometry-Based Dentifrice Abrasion Method for V8 Brushing Machines
Part II: Comparison of RDA-PE and Radiotracer RDA Measures
Eva Schneiderman, PhD Ellen Colón, BS Donald J. White, PhD
The Procter & Gamble Company
Cincinnati, OH, USA

Samuel St. John, PhD


University of Tennessee
Knoxville, TN, USA

Abstract
• Objective: The purpose of this study was to compare the abrasivity of commercial dentifrices by two techniques: the conventional gold
standard radiotracer-based Radioactive Dentin Abrasivity (RDA) method; and a newly validated technique based on V8 brushing that
included a profilometry-based evaluation of dentin wear. This profilometry-based method is referred to as RDA-Profilometry Equivalent,
or RDA-PE.
• Methods: A total of 36 dentifrices were sourced from four global dentifrice markets (Asia Pacific [including China], Europe, Latin
America, and North America) and tested blindly using both the standard radiotracer (RDA) method and the new profilometry method
(RDA-PE), taking care to follow specific details related to specimen preparation and treatment.
• Results: Commercial dentifrices tested exhibited a wide range of abrasivity, with virtually all falling well under the industry accepted
upper limit of 250; that is, 2.5 times the level of abrasion measured using an ISO 11609 abrasivity reference calcium pyrophosphate as the
reference control. RDA and RDA-PE comparisons were linear across the entire range of abrasivity (r2 = 0.7102) and both measures
exhibited similar reproducibility with replicate assessments. RDA-PE assessments were not just linearly correlated, but were also propor-
tional to conventional RDA measures.
• Conclusion: The linearity and proportionality of the results of the current study support that both methods (RDA or RDA-PE) provide
similar results and justify a rationale for making the upper abrasivity limit of 250 apply to both RDA and RDA-PE.
(J Clin Dent 2015;26:61–65)

Introduction
The testing of dentifrice abrasivity is important for ensur- 250 maximum for radiotracer and 200 for profilometry.9 In a
ing the safety of toothpastes used for maintaining desirable 2013 study, Sabrah and colleagues reported measuring higher
aesthetics of teeth throughout life. The gold standard method RDA values when using a refined version of the ISO profilom-
used to test dentifrice abrasivity is radiotracer RDA.1 The adap- etry method. The authors concluded: “Sp (surface profile
tation of profilometry methods as an alternative means of assess- method) needs further development before being considered
ing dentifrice abrasivity has been codified by the International as an equivalent method to Rt (conventional radiotracer
Organization for Standardization (ISO)2 and the British method).”6
Standards Institute (BSI).3 The ISO method is categorized in Recently, we reported on the successful development of a
the form of an annex to the standard methodologies for assess- highly refined profilometry-based abrasivity method, the RDA-
ments of dentin wear, as described by Addy.4 An important PE (Radioactive Dentin Abrasivity – Profilometry Equivalent),
part of the validation of alternative methodologies for abra- which permits abrasion comparisons following brushing in
sive wear is the correlation of contemporary methods to estab- standard V8 brushing machines without the need for irradiat-
lished radiotracer techniques, as these have been widely accept- ed teeth.10 Contrary to previous profilometry methods, the newly
ed for over three decades. While published studies and general developed method provides a direct linear correlation to the
acceptance of the ISO method support the suitability of pro- radiotracer RDA method across the scale used to measure den-
filometry to abrasivity comparisons, systematic validation for tifrice abrasivity. The success of these new developments has
published techniques has been less than ideal. Previous studies led us to conclude the RDA-PE method can now be consid-
that have attempted to directly compare specific profilometry- ered equivalent to the conventional radiotracer (RDA) method.
based techniques to conventional RDA have produced less While our previous publication demonstrated the validity of
than satisfactory comparisons, particularly across the full range the new method using a series of test products of known abra-
of required abrasivities.5-8 The possibility of non-proportional sivity (low, medium, and high), the current study assessed a
correlation between radiotracer RDA and profilometry meth- wide range of marketed products, using both conventional RDA
ods proposed at the time of ISO adoption resulted in the rec- and the RDA-PE methods to demonstrate the global applica-
ommendation for differing maximum abrasion limits, namely bility of the new profilometry method.

61
62 The Journal of Clinical Dentistry Vol. XXVI, No. 2

Materials and Methods use, specimens were polished using serial grit aluminum oxide paper
Profilometry experiments followed the protocol as described by to a final surface roughness Ra < 0.1 µm. Surface hardness of dentin
White et al.10 specimens was measured using a Buehler Vickers Hardness Indenter
1600-6305 (Buehler, an ATW Company, Lake Bluff, IL, USA) with
V8 Brushing Machine and Brushes Vickers indentations made on damp specimens at a load of 300
A standard V8 cross-brushing machine was used (Sabri Dental, grams. To be acceptable for the study, specimens were required to
1404 Brook Drive, Downers Grove, IL, USA). The toothbrush used have an initial Vickers hardness of 30–70 (dentin). Prior to brush-
in testing was an American Dental Association (ADA) P40 Soft ing, specimens were masked by polyester tape (PRO067-7, Argon
(Chicago, IL, USA), rectangular head toothbrush with flat-trim Masking Inc., Monrovia, CA, USA) to create a window with at
bristles. Brushes were pre-conditioned for 20,000 strokes on the V8 least 3 x 6 mm2 of surface exposed, yet providing enough coverage
brushing machine in water under standard conditions prior to use. on the edges to ensure a reference surface for profilometric evalua-
tion of abrasive tissue loss was present.
Specimen Preparation
Human teeth were collected as part of a longstanding retrieval Dentifrices and Reference Standard
program coordinated with local dentists in the Cincinnati, OH, Dentifrices to be tested were acquired from supermarkets in four
USA area. Plano-parallel dentin specimens were prepared from different geographical regions (Asia Pacific [including China], Europe,
human root dentin sectioned as 3 x 5 mm slabs and mounted in Latin America, and North America] and are listed in Table I, along
blocks of methyl methacrylate. These specimens were ground, pol- with a listing of the abrasive used in each and the pH of the prod-
ished, and qualified for geometry as described previously. For final uct slurries. Care was taken to include “whitening dentifrices” from
Table I
Dentifrices Compared in RDA and RDA-PE, Including Abrasive Type and Slurry pH
Region Dentifrice Manufacturer Abrasive pH
Greater China/India
Colgate® Cavity Protection Colgate-Palmolive Ca(HCO3)2 6.8
Colgate® Trifecta Colgate-Palmolive CaCO3 9.7
Colgate® 360 Colgate-Palmolive Silica 8.1
Colgate® Anti Cavity Whitening Colgate-Palmolive CaCO3, Silica 9.5
Colgate® Pro-Argin™ Colgate-Palmolive CaCO3, Silica 8.8
Colgate® Strong Teeth (India) Colgate-Palmolive CaCO3 9.3
Darlie Expert White Hawley & Hazel / Silica 7.9
Darlie Green Tea Colgate-Palmolive Silica 6.9
Crest® Salt White™ Procter & Gamble CaCO3, Silica 9.0
Europe
Colgate® Total Colgate-Palmolive Silica 7.1
Elmex - Cavity Protection (kids) GABA Silica 4.8
Meridol GABA Silica 4.7
Elmex Erosion Control GABA Silica, Alumina 4.6
Dentalux Lidl Stiftung & Co. KG Silica 6.9
Latin America
Colgate® Tripla Ação Colgate-Palmolive CaCO3 9.5
Colgate® Maxima Protección Anticaries Colgate-Palmolive dicalcium phosphate 6.9
Colgate® Luminous White Colgate-Palmolive Hydrated silica 8.4
Oral B® Procter & Gamble CaCO3 8.7
Crest® Complete Procter & Gamble Silica 7.3
North America
Arm & Hammer® Advance White Stain Defense Church and Dwight Silica, NaHCO3 9.1
Colgate® Cavity Protection Colgate-Palmolive dicalcium phosphate 6.8
Colgate® Total Colgate-Palmolive Silica 7.1
Colgate® Total Advanced Whitening Colgate-Palmolive Silica 7.1
Ultrabrite® Advanced Whitening Colgate-Palmolive Silica 7.7
Colgate® Optic White Platinum Colgate-Palmolive Silica, Ca pyrophosphate 7.4
Aquafresh® Whitening Action GlaxoSmithKline Silica 6.7
Sensodyne® GlaxoSmithKline Silica 9.2
Crest® Cavity Protection Procter & Gamble Silica 6.9
Crest® Complete Deep Clean Procter & Gamble Silica 6.4
Crest® Pro-Health® Whitening Procter & Gamble Silica 5.3
USP reference standard Procter & Gamble Silica 6.7
Crest® Cavity Protection Procter & Gamble Silica 6.9
Crest® 3D White Luxe Procter & Gamble Silica 7.6
Crest® Complete + Scope Procter & Gamble Silica 7.5
Crest® Pro-Health® Procter & Gamble Silica 5.5
USP reference standard Procter & Gamble Silica 6.9
Vol. XXVI, No. 2 The Journal of Clinical Dentistry 63

the marketplace, as well as standard paste controls. Dentifrices were


prepared for profilometry testing by diluting 25 grams of paste and
40 grams of water with vigorous homogenization/mixing. An abra-
sivity standard slurry was prepared by adding 10 grams of standard
ADA calcium pyrophosphate reference abrasive (ISO 11609, Odontex,
Inc., Lawrence, KS, USA) to 50 grams of 0.5% carboxymethylcellu-
lose (CMC, 7MF Blanose Na-CMC Ashland Specialty Chemicals,
Covington, KY, USA). The 0.5% CMC solution was prepared by
mixing 100 grams of CMC into 200 grams of glycerin and 1790.5
grams of hot (70˚C) deionized water. The solution was mixed on a
stir plate using a magnetic bar for at least 30 minutes. This CMC
solution was left undisturbed for 24 hours before use.

Brushing Method Figure 1. Comparison of conventional RDA values vs. RDA-PE method for marketed
Specimens were fixed in the V8 brushing machine standard mounts, dentifrices from four geographical regions.
taking care to ensure that the methacrylate was flush to the mount Virtually all commercial dentifrices exhibited abrasivity values well
base. The load of the brush on specimens was set to the RDA indus- within standard limits that have been historically established. RDA-
try standard of 150 grams and was verified at each V8 station using PE produced comparable results to RDA when measured against
a spring gauge each time a specimen was mounted. Brush oscilla- formulations sold globally. The linear correlation of the techniques
tions per minute (BOPM) of the V8 machine was set at 170. Brushing was excellent throughout the RDA range, with a slope of 0.965
strokes were tuned to have the brush head stroke across specimens and r2 = 0.71.
for the entire brush head with the brush, losing contact and re-estab- There was similarly low variance in RDA-PE and RDA assess-
lishing contact with each stroke reversal. Specimens were brushed ments; between 11–27% for RDA and 7–21% for RDA-PE. Results
for 4,000 strokes with either the test dentifrices or the ADA abrasive are captured in Figure 2 and in Table II.
standard. An internal RDA-PE 250 upper limit was achieved by brush-
ing with the abrasive standard for 10,000 strokes (2.5x the number
of strokes [4,000] used). All specimens were rotated through each of
the eight brushing stations (500 strokes on each brushing station) on
the V8 machine, and specimens were turned by 180˚ with each rota-
tion of 500 strokes. Dentifrice slurries were remixed at each rotation
to guard against abrasive settling.

Profilometry Assessments
Profilometric assessments of dentin wear were made with a Bruker
GT-K1 optical profilometer system (Bruker Corp, Billerica, MA,
USA). Mean depth of abrasion was measured as abraded depth
vs. control (masked area on the specimen surface).9

Correlation Studies: RDA Colgate Cavity Protection Crest Cavity Protection Crest Pro-Health Whitening
Standard radiotracer RDA values of test dentifrices were obtained
Figure 2. Variation in RDA-PE and RDA assessments of three different dentifrices –
through contract evaluations at the Therametrics laboratories (Dental individual measurements.
Product Testing Therametric Technologies, Inc., Noblesville, IN,
USA). Blinded dentifrices were shipped to the laboratory for stan- Table II
dard evaluations in radiotracer RDA assessments. RDA and RDA-PE Evaluations for
Control Dentifrices Tested Repeatedly
Variability in RDA and RDA-PE Assessments of Abrasivity Treatment* Replicates RDA # Study RDA-PE
Three dentifrices (Crest® Cavity Protection [Procter & Gamble (± SD) Replicates (± SD)
Company, Cincinnati, OH, USA], Colgate® Cavity Protection Crest Cavity Protection 26 100 (11) 8 118 (21)
[Colgate-Palmolive Company, New York, NY, USA] and Crest® Crest Pro-Health Whitening 14 197 (27) 11 188 (16)
Pro-Health® Whitening [Procter & Gamble]), representing three Colgate Cavity Protection 7 82 (12) 11 64 (7)
different ranges of dentifrice abrasivity, were evaluated in replicate *Dentifrices included in assessment were all sourced from North American markets.
tests for both RDA and RDA-PE to establish comparative vari-
ability in repeat measures with the techniques. Discussion
We have previously described the development of a method for
Results abrasivity based on specimens being treated using a V8 brushing
Figure 1 presents a graphical comparison of abrasion determined machine and assessed with profilometry.10 An important consider-
by RDA and RDA-PE, respectively, for the commercial pastes. ation in validating variations in methods for abrasivity is establish-
64 The Journal of Clinical Dentistry Vol. XXVI, No. 2

ing adequate correlations to gold standard radiotracer assessments. tems. Synchronizing safety limits between the two methods to 250,
As already described, this has proven difficult for previous pro- consistent with historically and accepted RDA values, results in
filometry-based methodologies across the complete range of desired resolution of the standard dilemma. Figure 3 shows how the reci-
sensitivity.5-8 We believe the strict protocol for brush pre-condition- procity of RDA and RDA-PE permits adoption of a common max-
ing, sample treatment, and post-treatment analysis in RDA-PE imum standard, at least for these specific techniques. The new method,
yields a satisfactory correlation to the gold standard RDA.10 The with a limit of 250, would find the “vast majority” of products test-
detail with which we have described this method makes it widely ed to be acceptable. Lower variance for RDA-PE at higher abra-
accessible to other professionals investigating this process. sion ranges and experimental determination of 250 in RDA-PE
Results of the current study showed a linear and proportional render the new method slightly more discriminating, since it includes
correlation between RDA assessed by radiotracer and RDA-PE. a firm point for the upper limit versus an extrapolated data point
The methods appear to be interchangeable in their capability to in RDA. Based on the outcomes of this study and our previous
assess dentifrice abrasivity. Overall, the range of abrasivities for study,10 there is no justification to maintain different maximum val-
commercial dentifrices observed in this study is consistent with ues when assessing the abrasivity of dentifrices, so long as the meth-
recent screenings of commercial dentifrices.11-13 It was noteworthy ods used are consistent with those reported herein.
to see in these studies that virtually all commercial dentifrices exhib- It should be noted that the topic of abrasive standards has become
ited abrasivity values well within standard limits that have been a subject of considerable academic, and some regulatory discus-
historically established. In addition, RDA-PE produced compara- sion in recent years, based on contemporary concerns over poten-
ble results to RDA when compared across formulations sold glob- tial changes since the establishment of methods and standards.14-16
ally, regardless of the abrasive used in each formulation. Some researchers have suggested that changes in dietary-induced
In developing this comparison, it was recognized that there is dental erosion, power tooth brushing, length of tooth retention,
technique variation for both methodologies in repeated assessments. etc., may warrant reconsideration of abrasion guidelines. While an
To assess this, three dentifrices were evaluated in replicate tests for interesting proposal, it can be argued that revisions in standards
both RDA and RDA-PE to establish reproducibility. Products includ- should be minimally based on support of at least comparable qual-
ed in this assessment were representative of the range of abrasivity ity to that which established current codified standards. In service
levels commonly sold in global dentifrice markets. Results are cap- to this discussion, a separate publication provides a historical review
tured in Figure 2 and in Table II, where RDA and RDA-PE were of the basis behind today’s established abrasivity standards for con-
found to have comparable reproducibility in replicate assessments. sideration by contemporary manufacturers, researchers, and regu-
The direct correlation of radiotracer RDA with RDA-PE strong- lators in future dialogues.17
ly suggests, for the first time, that maximum standards for both
techniques should be reciprocal. This avoids situations where spec- Conclusion
imens would exhibit acceptable abrasivity as assessed by RDA The linearity and proportionality of the results of the current
(< 250), and yet be above the maximum established within ISO guide- study support the position that either method (RDA or RDA-PE)
lines (> 200) if measured using previous profilometry methods. If provides suitable interchangeable measures of dentifrice abrasivity.
following the ISO guidelines, at least seven dentifrices from the group As an extension of this, RDA-PE can be applied in dentifrice abra-
tested would be excluded from the market based on RDA-PE assess- sivity testing with a safety limit comparable to RDA; namely 250.
ment without a justifiable reason (Figure 3). These seven denti-
frices are not unique in their compositions and come from differ- Acknowledgment: This study was supported by the Procter & Gamble Company.
ent manufacturers, are within the normal pH ranges, and have either Conflict of Interest Disclosure: Dr. Schneiderman, Ms. Colón, and Dr. White are
and/or both silica and/or calcium carbonate as their abrasive sys- employees of The Procter & Gamble Company. Dr. St. John was an employee of
the Procter & Gamble Company when he contributed to the research described
herein.

For correspondence with the authors of this paper, contact Dr. Donald
J. White – white.dj.1@pg.com.

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