Efficacy of a Mouthwash Containing 0.8% Arginine, PVM/MA Copolymer

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Efﬁcacy of a mouthwash containing 0.8% arginine, PVM/MA

copolymer, pyrophosphates, and 0.05% sodium ﬂuoride

compared to a negative control mouthwash on dentin

hypersensitivity reduction. A randomized clinical trial

a, b b b b

Deyu Hu *, Bernal Stewart , Sarita Mello , Lia Arvanitidou , Foti Panagakos ,

b b c a

William De Vizio , Yun Po Zhang , Luis R. Mateo , Wei Yin

Department of Preventive Dentistry, College of Stomatology, West China University of Medial Sciences, Chengdu, China

Colgate-Palmolive Technology Center, Piscataway, NJ, USA

LRM Statistical Consulting LLC, USA

a r t i c l e i n f o a b s t r a c t

Article history: Objective: The objective of this eight week, single-center, two-cell, double-blind, and ran-

Received 19 June 2012 domized clinical study was to evaluate the dentin hypersensitivity reduction efﬁcacy of a

Received in revised form mouthwash using Pro-Argin Mouthwash Technology containing 0.8% arginine, PVM/MA

24 August 2012 copolymer, pyrophosphates, and 0.05% sodium ﬂuoride in an alcohol-free base (‘‘Arginine

Accepted 1 October 2012 Mouthwash’’) compared to an ordinary mouthwash without any active ingredients (‘‘Nega-

tive Control’’).

Methods: Qualifying subjects who presented two hypersensitive teeth with a tactile hyper-

Keywords: sensitivity score between 10 and 50 g of force, and an air blast hypersensitivity score of 2 or 3

Efﬁcacy participated in this study and were randomized into one of two treatment groups. Subjects

Dentinal brushed with the toothbrush and ﬂuoride toothpaste provided and then rinsed with 20 mL of

Hypersensitivity their assigned mouthwash for 30 s twice daily. Subjects refrained from eating or drinking for

Mouthwash 30 min after rinsing. Dentin hypersensitivity assessments, as well as examinations of oral

Tactile hard and soft tissues, were conducted at the baseline visit and again after two weeks, four

weeks and eight weeks of product use.

Air Blast

Results: Ninety (90) subjects entered and completed the eight week study. After two weeks,

four weeks and eight weeks of product use, subjects in the Arginine Mouthwash group

exhibited statistically signiﬁcant ( p < 0.05) improvements in mean tactile and air blast

hypersensitivity scores as compared to the Negative Control Mouthwash.

Conclusion: The results of this study support the conclusion that the Arginine Mouthwash

provides a signiﬁcant reduction in dentin hypersensitivity after eight weeks of product use

as compared to a Negative Control mouthwash.

# 2012 Elsevier Ltd. Open access under CC BY-NC-ND license.

articles have ranged from discussions of its causes and

1. Introduction

management to current and new agents that have

been incorporated into oral health product formulations

Dentin hypersensitivity has been the subject of many which have been clinically proven to treat dentin hyper-

1–8

scientiﬁc publications over the past several years. The sensitivity.

* Corresponding author. Tel.: +86 285582167.

E-mail address: [email protected] (D. Hu).

0300-5712 # 2012 Elsevier Ltd. Open access under CC BY-NC-ND license. http://dx.doi.org/10.1016/j.jdent.2012.10.001

j o u r n a l o f d e n t i s t r y 4 1 s ( 2 0 1 3 ) s 2 6 – s 3 3 S27

40–42

The term dentin hypersensitivity is almost always de- containing potassium ion. This technology has also been

scribed as a short episode of sharp pain that arises from shown to provide instant relief after a single direct topical

43–45

exposed dentin, typically in response to chemical, thermal, application of the dentifrice.

tactile and osmotic stimulation. Up to 57% of patients have There are a variety of dental products known to success-

10–13

been reported to be affected by this condition. Most fully address dentine hypersensitivity. A new mouthwash

hypersensitive teeth are accompanied by gingival recession, using the Pro-Argin Mouthwash Technology was designed

the result of periodontal disease, periodontal therapy or to effectively reduce dentin hypersensitivity. The mouthwash

14,15 46,47

improper brushing. In a healthy tooth, the dental pulp is efﬁcacy is based on occlusion of the dentin tubules,

covered by dentin which is protected by enamel above the provided by a proprietary formulation of arginine, PVM/MA

gingiva and cementum and the gingiva themselves below the copolymer and pyrophosphates.

gingiva. Just as the enamel covers and protects the Therefore, the aim of this eight week, single-center, two-cell,

underlying dentin from external stimuli, the gingiva protects double-blind, and randomized clinical study conducted in the

the underlying cementum and root dentin. When the gingiva Chengdu, China area, was to evaluate the dentin hypersensi-

recedes, the protective cementum can be easily removed so tivity reduction efﬁcacy of two mouthwashes, one containing

that the dentin tubules are exposed and open, thereby 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05%

transmitting the pain producing stimuli. sodium ﬂuoride (‘‘Arginine Mouthwash’’) and the other con-

The hydrodynamic theory of dentin hypersensitivity taining 0.05% sodium ﬂuoride (‘‘Negative Control’’).

proposed by Brannstrom in 1963 remains the widely accepted

17,18

theory of how dentin hypersensitivity occurs. It attributes

2. Materials and methods

ﬂuid movement within exposed dentin tubules to the

transmission of painful sensation. Speciﬁcally, non-noxious

stimuli at the tooth surface can trigger ﬂuid movement within This clinical study employed a randomized assignment,

the dentin tubules affecting the pulpal mechanoreceptors and double-blind, two-treatment, parallel-group design. Adult

resulting in the sensation of pain. Under a microscope, a subjects from the Chengdu, China area were enrolled in the

sensitive tooth shows widened dentin tubules, as much as two study.

times larger than tubules of normal dentin, and in greater

number per area compared to a tooth without dentin 2.1. Sample size determination

hypersensitivity. Treatment and prevention of dentin

hypersensitivity focuses on eliminating the ability of external The sample size of 90 (45 per group) was determined based on

stimuli to trigger pain. Currently one of two approaches is a standard deviation (SD), for the response measure tactile

typically used. The ﬁrst is to block the triggers of nerve activity sensitivity (or air blast) of 3.34 (or 0.31), a signiﬁcance level of

by treating the tooth with a physical or chemical agent that a = 0.05, a 10% attrition rate and an 80% level of power. The

forms a layer which mechanically occludes the dentin tubules study was powered to detect a minimal statistically signiﬁcant

and prevents pulpal ﬂuid ﬂow. The second is by interrupting difference between the study means of 20%. The sample size

the neural response to pain stimuli by delivering potassium calculation utilized a historical data from previous studies.

salts to the tubule area where they have a depolarizing effect

on electrical nerve conduction, causing nerve ﬁbers to be less

2.2. Inclusion criteria

excitable to the stimuli, thereby reducing a patient’s sensation

of pain. The occluding agent or potassium salt is generally

delivered by incorporating it into an oral health product so that (i) had to be between the ages of 18 and 70 (inclusive) and in

patients can treat the condition at home during normal oral general good health,

20–23

hygiene procedures. (ii) required to possess a minimum of two hypersensitive

The most common products used by patients seeking pain teeth which were anterior to the molars and demonstrat-

relief from dentin hypersensitivity are desensitizing denti- ed cervical erosion/abrasion or gingival recession; and for

frices. In the past, these dentifrices usually contained which a tactile sensitivity stimuli score of 10–50 g of force

potassium salts – potassium nitrate, potassium citrate, (Yeaple Probe) and an air blast stimuli score of 2 or 3 (Schiff

potassium chloride – which are believed to have a depolarizing Cold Air Sensitivity Scale) were presented at the baseline

effect on electrical nerve conduction, causing nerve ﬁbers to examination,

24–39

be less excitable to the stimuli. Recently, a new dentifrice (iii) required to be available for the eight week duration of the

product was introduced which has been clinically proven to study and to sign an informed consent form.

provide superior dentin hypersensitivity relief. The dentifrice

contains 8% arginine, calcium carbonate and 1450 ppm Subjects were excluded from the study if they:

ﬂuoride as sodium monoﬂuorophosphate. Arginine, an amino

acid, historically has been studied for its potential oral health (i) had gross oral pathology, chronic disease, advanced

beneﬁts. It was shown that a combination of arginine and periodontal disease, had undergone treatment for peri-

calcium carbonate when deposited on exposed dentin odontal disease (within the last 12 months), or if they had

surfaces is able to physically block and seal open dentin hypersensitive teeth with a mobility greater than one,

tubules. The novel dentifrice has been reported in numerous (ii) had teeth with extensive/defective restorations (including

clinical studies to provide superior relief of dentin hypersen- prosthetic crowns), suspected pulpitis, caries, cracked

sitivity when compared to a leading sensitivity dentifrice enamel or that were used as abutments for removable

S28 j o u r n a l o f d e n t i s t r y 4 1 s ( 2 0 1 3 ) s 2 6 – s 3 3

partial dentures. Began taking anticonvulsants, antihis- baseline-designated study teeth, were conducted after

tamines, antidepressants, sedatives, tranquilizers, anti- two, four and eight weeks of product use. Subjects were

inﬂammatory drugs or daily analgesics within one month requested to return to the clinical facility having refrained

prior to the start of the study or if they started taking them from all oral hygiene procedures and from chewing gum for

during the course of the study, 8 h, and from eating and drinking for 4 h prior to their

(iii) were pregnant or lactating women, individuals who were scheduled visit. All examinations were performed by the

participating in any other clinical study or who had same dental examiner, using the same procedures as

participated in a desensitizing dentifrice study or who employed at baseline. Subjects were also interviewed with

used a desensitizing dentifrice within the last three respect to the presence of adverse events and the use of

months, concomitant medications.

(iv) had a history of allergy to the test products, or allergies to

oral care/personal care consumer products or their

ingredients, or had existing medical conditions, which 3. Clinical scoring procedures

precluded them from eating and drinking for periods up

to 4 h. 3.1. Tactile dentin hypersensitivity assessment

Prospective study subjects reported to the clinical facility Tactile dentin hypersensitivity was assessed by use of the

having refrained from all oral hygiene procedures, from Model 200A Electronic Force Sensing Probe developed by

chewing gum for 8 h, and from eating and drinking for 4 h Yeaple Research of Pittsford, NY. The application of this probe

prior to their examination. All prospective subjects who met for dental hypersensitivity testing utilizing a #19 explorer tip at

the inclusion/exclusion criteria and signed an informed a pre-set force measured in grams was employed.

48,49

consent form received a baseline tactile hypersensitivity Teeth were evaluated for tactile hypersensitivity in the

and an air blast hypersensitivity evaluation, along with an following manner:

oral soft and hard tissue assessment. Qualifying subjects were

sequentially randomized using a list of random numbers (1) The subject was instructed to respond at the point where

provided by study sponsors. he/she ﬁrst experienced discomfort.

For each subject who qualiﬁed for participation in the (2) The explorer tip of the probe was applied to the buccal

study, two hypersensitive teeth that satisﬁed the tactile and surface of each hypersensitive tooth at the CEJ.

air blast hypersensitivity enrollment criteria were identiﬁed (3) The explorer tip was stroked perpendicular to the tooth

for evaluation throughout the study. Qualifying subjects were beginning at a pre-set force of 10 g (0.01 kg) and increased

stratiﬁed based on mean tactile and air blast hypersensitivity by 10 g (0.05 kg) increments until the subject experienced

baseline scores and randomly assigned within strata to one of discomfort, or until 50 g (0.05 kg) of force was applied.

two study treatments: (1) a test mouthwash containing 0.8%

arginine, polyvinylmethyl ether/maleic acid (PVM/MA) copol- Subjectwise scores were calculated by averaging the values

ymer, pyrophosphates, and 0.05% sodium ﬂuoride in an measured on the two baseline-designated study teeth.

alcohol-free base (‘‘Arginine Mouthwash’’) (Colgate-Palmolive

Company, New York, NY), or (2) a mouthwash (‘‘Negative 3.2. Air blast dentin hypersensitivity assessment

Control’’) in an alcohol-free base without any active ingre-

dients (Colgate-Palmolive Company, New York, NY). Teeth were evaluated for air blast dentin hypersensitivity in

Mouthwashes were over-wrapped to maintain the blinding the following manner:

of the study participants, examiners and all study personnel.

Site personnel not involved in the clinical evaluations (1) The sensitive tooth was isolated from the adjacent teeth

distributed all test products in sealed opaque bags in an area (mesial and distal) by placement of the examiner’s ﬁngers

separate from the examination room. The three products were over the adjacent teeth.

letter coded. (2) Air was delivered from a standard dental unit air syringe at

2 2

Following treatment assignment, subjects were provided 60 psi (4.22 kgf/cm ) Æ 5 psi (0.35 kgf/cm ) and 70 8F

with toothpaste (Colgate Cavity Protection containing (21) Æ 3 8F (À16). The air was directed at the exposed

1450 ppm ﬂuoride) and a soft toothbrush (Colgate Adult buccal surface of the hypersensitive tooth for 1 s from a

Extra Clean) for home use. All mouthwashes were over- distance of approximately 1 cm.

wrapped in their original package to maintain the double- (3) The Schiff Cold Air Sensitivity Scale was used to assess

blind study design. Subjects were instructed to brush their subject response to this stimulus. This scale was scored as

teeth and then to immediately rinse their mouth with 20 mL of follows:

their assigned mouthwash for 30 s twice daily (morning and 0 – Subject did not respond to air stimulus.

evening) and to use only the toothpaste, toothbrush and 1 – Subject responded to air stimulus but did not request

mouthwash provided. Subjects were not allowed to ﬂoss or discontinuation of stimulus.

use inter-dental stimulators or to eat or drink for 30 min after 2 – Subject responded to air stimulus and requested

rinsing. There were no restrictions regarding diet or smoking discontinuation or moved from stimulus.

habits during the course of the study. 3 – Subject responded to air stimulus, considered stimulus

Oral soft and hard tissue assessments, as well as tactile to be painful and requested discontinuation of the

and air blast hypersensitivity follow-up evaluations of stimulus

j o u r n a l o f d e n t i s t r y 4 1 s ( 2 0 1 3 ) s 2 6 – s 3 3 S29 Clinical Study to Evaluate the Dentin Hypersensibility Reduction Efficacy of Mouthwash Containing 0.8% Arginine in Adults in China

Enrollment Assessed for eligibility (n=100)

Excluded (n= 0) Not meeting inclusion criteria (n=0) Declined to participate (n= 0) Randomized (n=100) Other reasons (n=0)

Negave Control Mouthwash Arginine

Allocation Allocation

Allocated to intervention (n=50) Allocated to intervention (n=50) Received allocated intervention (n=45) Received allocated intervention (n=45) Did not receive allocated intervention (n=5) Did not receive allocated intervention (n=5)

Follow-Up Follow-Up

Lost to follow-up (n=0) Lost to follow-up (n=0) Discontinued intervention (n=0) Discontinued intervention (n=0)

Analysis Analysis

Analysed (n= 45) Analysed (n= 45) Excluded from analysis (n=0) Excluded from analysis (n=0)

Fig. 1

3.3. Oral soft and hard tissue assessment hypotheses were two sided, and employed a level of

signiﬁcance of a = 0.05.

The dental examiner visually examined the oral cavity and

peri-oral area using a dental light and dental mirror at all

5. Results

hypersensitivity evaluations. This examination included an

evaluation of the soft and hard palate, gingival mucosa,

buccal, mucosa, mucogingival fold areas, tongue, sublingual Ninety (90) subjects entered the study, from December 29, 2010

and submandibular areas, salivary glands, and the tonsilar to February 28, 2011 complied with the protocol, and

and pharyngeal areas. completed the eight week clinical study (Fig. 1). A summary

of the gender and age of the study population is presented in

3.4. Adverse events Table 1. The treatment groups did not differ signiﬁcantly with

respect to either of these characteristics. Throughout the

Adverse events were obtained from an interview with the study, there were no adverse events on the oral soft or hard

subjects and from a dental examination by the investigator. tissues of the oral cavity observed by the examiner or reported

by the subjects when questioned.

Table 2 presents a summary of the mean tactile hypersen-

4. Statistical methods

sitivity scores for each of the treatment groups at each of the

measurement time points. Table 3 presents a summary of the

Statistical analyses were performed separately for the tactile mean air blast scores for each of the treatment groups at each

hypersensitivity assessments and air blast hypersensitivity of the measurement time points. Tables 2 and 3 also contain a

assessments. Comparisons of the treatment groups with comparison of the percent difference in the two treatments at

respect to gender were performed using a chi-square analysis each of the time points. At baseline there was not a

and for age an analysis of variance (ANOVA). Comparisons of statistically signiﬁcant difference between the two treatment

the treatment groups with respect to baseline-adjusted groups with respect to either mean tactile or mean air blast

tactile hypersensitivity and air blast hypersensitivity scores hypersensitivity scores.

at the follow-up examinations were performed using an After two weeks of product use, the Arginine Mouthwash

analysis of covariance (ANCOVA). All statistical tests of group exhibited a statistically signiﬁcant improvement in

S30 j o u r n a l o f d e n t i s t r y 4 1 s ( 2 0 1 3 ) s 2 6 – s 3 3

Table 1 – Summary of age & gender for subjects in the in pain. Once the stimulus is removed, the pressure within the

eight week clinical study. tubule returns to normal and the pain is alleviated.

There are two scientiﬁcally accepted approaches to treat

Treatment Number of subjects Age

dentin hypersensitivity. One is to occlude exposed tubules and

Male Female Total Mean Range

the other is to suppress nerve activity. With tubular occlusion,

Arginine Mouthwash 20 25 45 46.2 21–63

the tooth is treated with a physical or chemical agent that

Negative Control 20 25 45 46.6 25–67

forms a layer that mechanically occludes the dentin tubules

and prevents pulpal ﬂuid ﬂow, thereby, decreasing dentin

53,54

baseline-adjusted mean tactile hypersensitivity score relative hypersensitivity. In suppressing nerve activity, the tooth is

to the Negative Control group by 22.1%. With respect to air treated with an agent that increases the nerve depolarization

blast scores, the Arginine group exhibited a statistically threshold, and thus modulates or suppresses the sensation of

55,56

signiﬁcant reduction in baseline-adjusted mean hypersensi- pain.

tivity score relative to the Negative Control group by 14.2%. Research has indicated that the ideal dentin hypersensi-

After four weeks of product use, the Arginine Mouthwash tivity treatment should mimic natural desensitizing processes

group exhibited a statistically signiﬁcant improvement in leading to spontaneous occlusion of open dentin tubules.

baseline-adjusted mean tactile hypersensitivity score relative Kleinberg and coworkers developed a dentin hypersensitivity

to the Negative Control group by 37.1%. With respect to air treatment consisting of 8% arginine (an amino acid found in

blast scores, the Arginine group exhibited a statistically saliva), and calcium carbonate. This technology mimics

signiﬁcant reduction in baseline-adjusted mean hypersensi- saliva’s natural process of plugging and sealing open dentin

tivity score relative to the Negative Control group by 24.1%. tubules. When applied to exposed dentin, open dentin

After eight weeks of product use, the Arginine Mouthwash tubules are sealed with a plug that reduces dentin hypersen-

group exhibited a statistically signiﬁcant improvement in sitivity. This technology was ﬁrst introduced as a desensitiz-

baseline-adjusted mean tactile hypersensitivity score relative ing prophylaxis paste with 8% arginine and calcium carbonate

to the Negative Control group by 44.6%. With respect to air for professional use.

blast scores, the Arginine group exhibited a statistically Research continued with the arginine/calcium carbonate

signiﬁcant reduction in baseline-adjusted mean hypersensi- combination and led to the development of a dentifrice

tivity score relative to the Negative Control group by 24.0%. containing 8.0% arginine, calcium carbonate, and sodium

monoﬂuorophosphate. The dentifrice physically seals den-

tin tubules with a plug that contains arginine, calcium

6. Discussion

carbonate and phosphate. The plug is resistant to normal

pulpal pressures and to acid challenge and thereby reduces

Dentin is structurally composed of hydroxyapatite mineral dentin ﬂuid ﬂow and reduces dentin hypersensitivity.Clini-

and organic components and is formed by the odontoblasts cal studies have shown that this dentifrice containing 8%

during tooth development. It contains thousands of tubules arginine, calcium carbonate and 1450 ppm sodium mono-

which run perpendicular to the pulp chamber and which are ﬂuorophosphate provides superior efﬁcacy in reducing

formed as the odontoblasts migrate away from the dentin- dentin hypersensitivity as compared to a leading desensitiz-

51,52 40–42

enamel junction during dentin formation. Dentin is ing dentifrice containing 2% potassium ion. In addition,

normally covered by enamel or cementum. When teeth direct topical self-application of the product to the sensitive

erupt, the gingival margin seals the teeth leaving the coronal site has been shown to provide instant relief of dentin

43–45

portion exposed in the oral cavity and the root portion of the sensitivity.

tooth protected from the external environment. Exposed As an alternative or a complement to using a desensitizing

dentin and open tubules patent to the pulp cause hypersen- dentifrice, a new mouthwash formulation has been developed

sitive teeth. which contains 0.8% arginine, in combination with pyropho-

The mechanism by which dentin hypersensitivity occurs is sphates and a PVM/MA copolymer to trigger tubule occlusion,

that external stimulus triggers a pressure change in the dentin and 0.05% sodium ﬂuoride. This new mouthwash was

ﬂuid, the ﬂuid movement transmits a signal to the odontoblast compared to a Negative Control mouthwash containing

process, and the process carries the stimulus from the tooth 0.05% sodium ﬂuoride to determine its relative effects in

surface toward the nerve ending in the dentin tubule, resulting relieving dentin hypersensitivity over an eight week period.

Table 2 – Summary of the tactile hypersensitivity scores for subjects who completed the eight-week study.

Treatment No. Baseline 2-Week % Difference 4-Week % Difference 8-Week % Difference

b b b

(mean Æ SD) (mean Æ SD) 2-week (mean Æ SD) 4-week (mean Æ SD) 8-week

Arginine Mouthwash 45 17.22 Æ 4.20 26.33 Æ 11.79 22.1% 32.44 Æ 12.41 37.1% 38.22 Æ 10.23 44.6%

Negative Control 45 17.00 Æ 5.78 21.56 Æ 8.84 23.67 Æ 12.13 26.44 Æ 12.60

Treatments are not statistically significantly different from each other at baseline.

At each time point, statistically significantly percentage differences ( p < 0.05) as per the ANCOVA comparison of baseline-adjusted means

are shown.

j o u r n a l o f d e n t i s t r y 4 1 s ( 2 0 1 3 ) s 2 6 – s 3 3 S31

Table 3 – Summary of the air blast hypersensitivity scores for subjects who completed the eight-week study.

Treatment No. Baseline 2-Week % Difference 4-Week % Difference 8-Week % Difference

b b b

(mean Æ SD) (mean Æ SD) 2-week (mean Æ SD) 4-week (mean Æ SD) 8-week

Arginine 45 2.33 Æ 0.39 1.81 Æ 0.67 14.2% 1.42 Æ 0.46 24.1% 1.30 Æ 0.57 24.0%

Mouthwash

Negative 45 2.33 Æ 0.40 2.11 Æ 0.57 1.87 Æ 0.60 1.71 Æ 0.54 Control

Treatments are not statistically significantly different from each other at baseline.

At each time point, statistically significantly percentage differences ( p < 0.05) as per the ANCOVA comparison of baseline-adjusted means

are shown.

2. Ayad F, Ayad N, Zhang YP, DeVizio W, Cummins D, Mateo

The results from the study indicate that:

LR. Comparing the efﬁcacy in reducing dentinal

hypersensitivity of a new toothpaste containing 8.0%

after two weeks, four weeks and eight weeks of product use,

arginine, calcium carbonate and 1450 ppm ﬂuoride to a

the Arginine Mouthwash group exhibited statistically commercial sensitive toothpaste containing 2% potassium

signiﬁcant ( p < 0.05) improvements (22.1%, 37.1% and ion: an eight-week clinical study on Canadian adults. Journal

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dentinal hypersensitivity of a new toothpaste containing

the Arginine Mouthwash group exhibited statistically

8.0% arginine, calcium carbonate and 1450 ppm ﬂuoride to a

signiﬁcant ( p < 0.05) reductions (14.2%, 24.1% and 24.0%

commercial sensitive toothpaste containing 2% potassium

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