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ORIGINAL ARTICLE
Year : 2016  |  Volume : 6  |  Issue : 2  |  Page : 113-118

Effectiveness of 8% proargin containing toothpaste in the treatment of dentinal hypersensitivity


M. A. Rangoonwala College of Dental Sciences and Research Centre, Pune, Maharashtra, India

Date of Web Publication3-May-2016

Correspondence Address:
Mrunal Chandrakant Kewal
Shankar Seth Road, Mira Society, Building Number 11, Pune, Maharashtra
India
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DOI: 10.4103/2249-9725.181696

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  Abstract 

Objective: This randomized control clinical trial was conducted to study the effectiveness of 8% proargin containing toothpaste in the control of dentinal hypersensitivity (DH) over a period of 4 weeks. Materials and Methods: 40 subjects with established DH were selected. DH was evaluated using thermal, air blast and tactile stimuli. Subjects were randomly divided into study and control groups and were advised to use commercially available 8% proargin (Mfd by-Colgate Palmolive (India) Ltd, Plot No. 78, EPIP Phase I, Jharmajri, Bddi, Tehsil Nalagarh, District Solan, Himachal Pradesh 174103) containing toothpaste and commercially available desensitizing toothpaste containing 2% potassium ion respectively. Subjects response was evaluated at baseline and 4 weeks after the application. Conclusion: When used over a period of 4 weeks, 8% proargin containing toothpaste provided significantly greater relief.

Keywords: Desensitizing agents, hypersensitivity, proargin, toothpaste, visual analog scale


How to cite this article:
Kewal MC, Jain S, Hegde R, Muglikar S. Effectiveness of 8% proargin containing toothpaste in the treatment of dentinal hypersensitivity. Univ Res J Dent 2016;6:113-8

How to cite this URL:
Kewal MC, Jain S, Hegde R, Muglikar S. Effectiveness of 8% proargin containing toothpaste in the treatment of dentinal hypersensitivity. Univ Res J Dent [serial online] 2016 [cited 2017 Jun 25];6:113-8. Available from: http://www.urjd.org/text.asp?2016/6/2/113/181696


  Introduction Top


Dentinal hypersensitivity (DH) can be defined as an exaggerated response to nonnoxious stimuli including thermal, tactile, evaporative and osmotic irritation. The response to a stimulus varies from person to person due to differences in pain tolerance, environmental factors and emotional state. The prevalence of DH ranges from 8% to 74% among adult population and can reach as high as 98% among people with periodontal disease.[1],[2],[3] DH can cause considerable pain to patients and affect oral health-related quality of life.[4],[5]

Hypersensitive teeth demonstrate tubular diameters that are significantly wider than those of nonsensitive teeth.[6] Various treatment options have been tried to manage this condition, but still DH continues to be a problem. It seemed that oral care professionals felt confident diagnosing DH, but not treating it and there was considerable uncertainty in the treatment, due to shortage of effective methods against DH.[7],[8]

Various modalities have been used to manage DH. Some of them include interference with the nerve transmission, protein precipitation, occluding the dentinal tubules,[9] dentin adhesive sealants, lasers etc.

Arginine containing toothpaste are based on the principle of occluding Dentinal tubules. They were first reported to have an antisensitivity effect in 2002. The explanation was that the combination of arginine bicarbonate and calcium carbonate was able to mimic natural desensitizing process of the saliva and could be deposited on the exposed dentin surfaces to form a plug that physically blocked and sealed the opened dentinal tubules so as to reduce DH.[10]

Thus, the purpose of this study was to evaluate the effectiveness of 8% proargin containing toothpaste in the treatment of DH.


  Materials and Methods Top


The Ethics Committee of M. A. Rangoonwala College of Dental Sciences, Pune approved the study. Consent was obtained from all the enrolled subjects. The CONSORT guidelines for clinical trials were followed. 100 patients were recruited for the study from the outpatient Department of Periodontology and Implantology. Out of these 40 subjects satisfying the inclusion criteria were selected.

Twenty chits with Group 1 written on them and twenty with Group 2 written on them were prepared. Subjects were randomly allocated into study and control groups by asking them to pick up chits.

In Group 1 subjects were advised to use toothpaste containing 8% proargin which was the study group.

In Group 2 subjects were advised to use commercially available desensitizing toothpaste with 2% potassium ion which was the control group.

Investigator 2 distributed toothpaste to the subjects whereas investigator 1 recorded the readings. Investigator 1 and investigator 2 were never jointly present with the study subjects. Study subjects were instructed not to discuss the study design with investigator 2 and not to reveal the toothpaste name to investigator 1.

Males and females of 19–60 years of age were included in the study. Subject should have at least 2 hypersensitive teeth with cervical defects. Subjects with teeth having attrition and erosion were excluded. Pregnant women were excluded from the study.

To assess tooth sensitivity following three stimuli were used:

  • Tactile stimulus: A sharp dental explorer was passed lightly across the affected area (mostly cervical) of the tooth, perpendicular to its long axis
  • Air blast stimulus: A blast of air from a dental syringe was directed onto the affected area of the tooth from a distance of 10 mm
  • Thermal stimulus: 2 ml of ice cold water was applied to the exposed dentin surface using a syringe while neighboring teeth were isolated during testing using cotton rolls.


A period of at least 5 min was allowed between the two stimuli on each tooth. For all stimuli the response of patients was recorded on a 10 cm long visual analog scale (VAS) that was labeled from “no pain” (0) to “intolerable pain” (10). Baseline VAS scores were recorded. Then subjects were instructed to brush their teeth twice a day for 2 min each time with soft-bristled toothbrush using the given toothpaste. Reductions in VAS with respect to air blast, thermal and tactile stimulus were calculated for both study and control groups after a period of 4 weeks and then compared.

Statistical analysis

In this randomized control, clinical trial DH was assessed using VAS. Reductions in VAS were calculated for both study and control groups and then compared. Comparisons between the groups were done using Mann–Whitney U-test. Differences between before and after VAS scores within each group were analyzed by Wilcoxon signed Ranks test. Significance level was taken as 0.05. The entire data was statistically analyzed using Statistical Package for Social Sciences (SPSS version 11.5, Inc., Chicago, USA) for Windows.


  Results Top


A total of 40 subjects complied with the protocol and completed the clinical study. Throughout the study, there were no adverse effects on the soft or hard tissues of the oral cavity. VAS scores of patients in Group 1 and Group 2 at baseline and after end of 4th week of toothpaste use for thermal, air blast and tactile stimuli are represented in [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6] respectively and [Graph 1], [Graph 2], [Graph 3] respectively.
Table 1: Comparison of pain score in Group 1 and Group 2 at baseline and at 4th week for thermal stimulus

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Table 2: Comparison of median pain score in group 1 and group 2 at baseline and at 4th week for thermal stimulus

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Table 3: Comparison of pain score in group 1 and group 2 at baseline and at 4th week for airblast stimulus

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Table 4: Comparison of median pain score in group 1 and group 2 at baseline and at 4th week for airblast stimulus

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Table 5: Comparison of pain score in group 1 and group 2 at baseline and at 4th week for tactile stimulus

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Table 6: Comparison of median pain score in group 1 and group 2 at baseline and at 4th week for tactile stimulus

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By thermal stimulus the median pain score was found to be 8 in Group 1 and 2 at baseline. And at the end of 4th week median pain score was found to reduce to 5 in Group 1 and 6 in Group 2. By using Mann–Whitney U-test for statistical analysis, there was no significant difference between median pain score in Group 1 and 2 at baseline (P > 0.05). Whereas there was significant difference between median score in Group 1 and Group 2 at the end of 4 weeks (P < 0.05). More reduction in the VAS score was found in the Group 1 using proargin containing toothpaste [Table 2].

Similarly, when sensitivity assessment was done using air blast stimulus the median pain score was found to be 8 in both the groups at baseline. Whereas at the end of 4th week it reduced to 6 in Group 1 and 7 in Group 2. There was found to be no significant difference between Group 1 and Group 2 according to the Mann–Whitney U-test used for statistical analysis (P > 0.05) at baseline but statistically significant difference (P < 0.05) was found in median pain scores in Group 1 and Group 2 at end of 4 weeks [Table 3] and [Table 4]. The reduction was significantly more in the group using proargin containing toothpaste.

When the sensitivity assessment was done using tactile stimulus the median pain score was found to be 7.5 and 8 in Group 1 and 2 respectively. At the end of 4th week this score reduced to 6 in Group 1 and 7 in Group 2. Thus, according to the Mann–Whitney U-test used for statistical analysis, there was no significant difference between median pain score in Group 1 and Group 2 at baseline (P > 0.05) but statistically significant difference (P < 0.05) was found in median pain scores in Group 1 and Group 2 at end of 4 weeks when tactile stimulus was used for sensitivity testing [Table 5] and [Table 6].

The intragroup comparison for evaluating the efficacy of thermal, air blast and tactile stimuli was done using Wilkoxon sign rank test. In both the groups, there was statistically significant reduction baseline VAS scores assessed by thermal, air blast and tactile stimuli at day 28 [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12]. The Group 1 (proargin group) [Table 7], [Table 9] and [Table 11] was found to be better in reducing VAS scores assessed by thermal, air blast and tactile stimuli compared to the Group 2 (2% potassium ion containing group) [Table 8], [Table 10] and [Table 12]. The changes of air blast stimuli, tactile stimuli and thermal stimuli were highly significant in the Group 1 (8% proargin group) at day 28 than Group 2 (2% potassium ion containing group) (P< 0.001). [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12].
Table 7: Comparison at baseline and at 4th week with respect to thermal stimulus for group 1

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Table 8: Comparison at baseline and at 4th week with respect to thermal stimulus for group 2

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Table 9: Comparison at baseline and at 4th week with respect to airblast stimulus for group 1

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Table 10: Comparison at baseline and at 4th week with respect to airblast stimulus for group 2

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Table 11: Comparison at baseline and at 4th week with respect to tactile stimulus for group 1

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Table 12: Comparison at baseline and at 4th week with respect to tactile stimulus for group 2

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  Discussion Top


DH is an inexorable conundrum that is faced by majority of dental professionals in day to day practice and has created bewilderment for researchers since the past century. DH is perhaps a symptom complex rather than a true disease and results from stimulus transmission across exposed dentin.

Etiology of DH can be attributed to dentin exposure which can occur by 2 processes [11] (a) loss of enamel or (b) denudation of the root surface or loss of covering periodontal structures usually termed as “gingival recession.” Loss of enamel occurs due to attrition, abrasion, erosion, iatrogenic factors and abfraction,[12] Denudation of root surface occurs due to aging, chronic periodontal disease, tooth abnormally positioned in the arch, periodontal surgery, incorrect tooth brushing habits and root preparation.[13] It is noteworthy that although many individuals are seen to have exposed dentin, not all experience symptoms of DH. Ishikawa et al. (1969)[14] observed that areas of sensitive cervical dentin show patent dentinal tubules. Branstrom et al. (1980) and Johnson et al. (1982)[15] hypothesized that in those individuals where no symptoms arise from dentin exposure, occlusion of tubules may have resulted from the formation of dead tracts with the laying down of irregular secondary dentin, or the development of sclerosed dentin.

The aim of this study was to evaluate the effectiveness of 8% proargin containing toothpaste used for prevention of DH. Assessment of DH can be done using verbal rating scales, VAS, verbal descriptor checklists, Mcgills word descriptors and hospital anxiety and description scale.

A VAS is a line 10 cm in length, the extremes of the line representing the limits of the pain a patient might experience from an external stimulus (no pain at one end and most severe pain at the other end of the line). Patients are asked to place a mark on the 10 cm line which initiates the intensity of their current level of sensitivity or discomfort following application of test stimuli. Several investigators have compared VAS with other pain scales and the results indicate that the VAS correlates well with these methods and appears to be more sensitive in discriminating between various treatment and changes in pain intensity. (Ekoswski et al. 1972, Joyce et al. 1975, Ohnhaus and Adler 1975).[16] The VAS scores for air blast and thermal test reduced in both groups, but there was a significantly more reduction in Arginine-CaCO3 group. Reduction in VAS was found to be more in the study group as compared to control group.

The tests used for assessment included tactile test, a controlled air blast stimulus, and thermal stimulus. Dentin sensitivity may differ according to different stimuli, and it is recommended that at least two hydrodynamic stimuli be used in the clinical trial. Only air blast test was applied in some studies, but the use of tactile and thermal stimuli is also recommended, because, some patients may not experience sensitivity when only air blast stimulus is used.[17] Therefore, in our study, all three methods were performed and 5 min gap was allowed between two stimuli to minimize interactions.

Various materials have been tried and tested for the treatment of DH. The most commonly used desensitizing toothpaste include those containing oxalates, fluorides, sodium monofluorophosphate, stannous fluoride. Novamin and proargin containing toothpaste are recent advances in the range of desensitizing agents. Grossman (1935)[18] suggested requirements for a satisfactory material for the treatment of DH which includes the following nonirritant to the pulp, relatively painless on application, easily applied, rapid in action, effective for a long time and consistently effective.

We used the recently developed proargin technology for treatment of DH. Proargin contains arginine, an amino acid naturally found in saliva, and calcium carbonate. Several studies suggest that at physiologic pH, arginine and calcium carbonate interact, and bind to the negatively charged dentin surface to form a calcium-rich layer on the surface and into the dentinal tubules to plug and seal them.

Arginine an essential amino acid was first isolated from a lupin seedling extract in 1886 by the Swiss chemist Ernst Schultze and has been investigated as arginine bicarbonate together with calcium carbonate for its ability to occlude dentin tubules and reduce pain from DH.[19]

There have been other studies which evaluated the effectiveness of proargin containing toothpaste. Schiff et al. (2009)[20] in their in vivo study reported that proargin provided significant reduction in DH after a single application following phase 1 therapy and the relief lasted for 4 weeks. Docimo et al. (2009)[21] introduced a toothpaste containing 8.0% proargin, and 1450 ppm fluoride as sodium monofluorophosphate and stated that it provided significantly increased DH relief (P < 0.05) compared to a commercial desensitizing toothpaste containing 2% potassium ion after 2 weeks, 8 weeks, and 8 weeks of their use.

However, in contrast, there are studies comparing the two new technologies, i.e., proargin and NovaMin (commercially available bioactive glass based toothpaste). West et al. (2011)[22] and Aditya Rao et al. (2014)[23] in their studies showed NovaMin to be more effective than Pro-argin on a longer duration period.

Thus, to conclude, it was found that 8% proargin containing toothpaste provided significantly greater relief in DH after 4 weeks of use than the other commercially available desensitizing toothpaste. More studies with larger sample size, longer follow-up and those using more parameters for accurate analysis of DH need to be carried out.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9], [Table 10], [Table 11], [Table 12]



 

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