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Authors: Dr. Manoj Kumar Hans, Dr. Ashish Modh, Dr. Rinki Hans

Abstract:

Aim and objectives: This study had twin objectives to compare the effectiveness of Sensodyne repair and protect Paste (NovaMin with fluoride), to a Vantej paste (NovaMin without fluoride), in reducing dentin hypersensitivity immediately after a single application and to compare the duration of sensitivity relief up to 15 days after a single application of both paste with NovaMin, with or without fluoride. Materials and method: Air blast technique was used to carry out baseline score and the scores were given on a 10 cm sensitivity visual analog scale, scale had ratings from No Pain 0-1, for mild pain 2-3, for moderate 4-6 and for severe pain 7-10. Teeth of interest were isolated and wiped using cotton rolls again after baseline examination. The two desensitizing pastes, prescribed in this study included: Group I Vantej desensitizing toothpaste and Group II Sensodyne repair and protect desensitizing paste. Subjects were instructed for home application such as twice application of desensitizing paste for two mins daily and to report after 15 days.

Results: No statistically significant scores were obtained between the groups when difference between baseline scores and after 2 min scores was taken. However in both the groups, we observed statistically significant differences when their baseline scores were compared with their after 2 min evaluation scores. No statistically significant difference observed in both groups after 15 days of evaluation. Conclusion: Both NovaMin pastes were effective and there was no statistical difference between the pastes with and without fluoride.

Keywords: Calcium sodium phosphosilicate, Hypersensitivity, Novamin

Introduction

Dentine hypersensitivity is a common condition of transient tooth pain caused by a variety of exogenous stimuli.1 These exogenous stimuli include thermal (cold), tactile (touch) or osmotic changes (sweets or drying the surface). While extreme stimuli can make all teeth hurt, the “hyper” sensitivity reffered as painful response to stimulus which is not normally associated with pain. The response to a stimulus varies toindividual due to differences in environmental factors, pain tolerance and emotional state.2 Dentinal hypersensitivity is described clinically as an exaggerated response to an non noxious stimuli, it is viewed as originating from underlying exposed dentin after enamel and cementum have been eroded away.3 The hypersensitivity occurs by direct nerve stimulation, irritation of odontoblastic processes and by hydrodynamic flow in open dentin tubules. This theory, originally proposed by Gysi and later refined by Brännström, describes the most accepted mechanism for explaining the sensitivity response.4 Laboratory models of sensitive teeth viewed by scanning electron microscope revealed varying numbers of open or partially occluded dentin tubules.5-7

Non-sensitive surfaces have been shown to have tubules that are filled with mineral.8 Therefore, it follows that occluding materials applied to exposed sensitive dentin surfaces should desensitize teeth by preventing stimuli from activating the intra-dental nerves. Calcium sodium phosphosilicate, known by Novamin, has been in use since the late 1960s, and was originally used for the development of bone regeneration materials.9 Novamin is an inorganic, amorphous melt-derived glass compound that contains calcium, sodium, phosphate, and silica. This compound has been used safely for a number of years in many applications, has been tested repeatedly for biocompatibility, and has been cleared by the United States Food and Drug Administration for use in numerous medical devices. The mode of action for Novamin as a desensitizing agent is to occlude the dentin tubules physically. In an aqueous environment this action occurs rapidly, such as saliva, the local pH increases due to immediate release of sodium ions by novamin. This allows rapid precipitation of particles and the layer of a calcium hydroxyapatite mineral is formed on the dentin surface. In addition, laboratory tests have repeatedly demonstrated that a single application of a sufficient concentration (>3%) of Novamin will block open dentin tubules and will resist acid challenges.10 This makes NovaMin an innovative addition to prophylaxis paste, as the procedure typically lasts for a few minutes, and the affects can be seen immediately. Novamin particles interacts with collagen have been studied by a number of research groups in various in vitro studies.11,12 These studies have shown the positive interaction between the reacted surface of the particles with collagen of exposed dentin which has a high content of exposed collagen.10 This action could provide lasting relief to patients after just one application of prophylaxis paste with NovaMin. Therefore, the purpose of this study was to compare the effectiveness of Sensodyne repair and protect Paste (NovaMin with fluoride), to a Vantej paste (NovaMin without fluoride), in reducing dentin hypersensitivity immediately after a single application. Inclusive in the primary objective was the assessment of safety, which was based on intraoral exams and subject responses to the treatment. The secondary objective of this study was to compare the duration of sensitivity relief up to 15 days after a single application of both paste with NovaMin, with or without fluoride.
Materials and Method:

This clinical trial was carried out in Department Of Conservative Dentistry And Endodontics, Vyas Dental College and hospital, Jodhpur. Prior to the study, ethical approval was taken from institutional ethical committee and written consent was obtained from all the study subjects. Forty subjects including 7 female and 33males became part of this clinical trial. As per inclusion criteria in the study, each subject had to have minimum of two dentin hypersensitive teeth and a minimum of score 3 on Schiff cold air sensitivity scale,other criteria which may have demonstrated cervical erosion, abrasion and/or gingival recession. Non-adjacent most sensitive two teeth were selected for this clinical trial.

The exclusion criteria for the clinical trial were current history of allergy to any of the test product, use of antidepressants, use of any desensitizing paste on tooth of interest within the last 3 months, sedatives or analgesics drugs, pulpitis, restorations, cracked enamel. The clinical trial was carried out by a single examiner who was well trained and calibrated.

Methodology

Isolation of teeth prior to application of paste. Prior to baseline examination subjects were instructed to avoid analgesics. Air blast technique was used to carry out baseline scoreand the scores were given on a 10 cm sensitivity visual analog scale, scale had ratings from No Pain 0-1, for mild pain 2-3, for moderate 4-6 and for severe pain 7-10.13

Each teeth of interest were isolated and wiped using cotton rolls again after baseline examination. Subjects were asked to apply pea size amount of assigned paste on hypersensitive teeth for two minute with finger tip by massaging according to a study done by Yiming Li and Sean Lee in 2011.14 After that score was taken on VAS same done for baseline examination.

According the desensitizing paste, subjects were divided in two groups. The two desensitizing pastes, prescribed in the this study included: Group I Vantej desensitizing toothpaste containing Novamin (Dr. Reddy’s company, India) and Group II Sensodyne repair and protect desensitizing paste (GSK group of companies, india). Subjects were instructed for home application such as twice application of desensitizing paste for two mins daily and to report at department after 15 days. Follow up examination after 15 days was carried out which was in the same manner as baseline examination was done.

Statistical analysis: All the statistics were carried out using SPSS version 17. Comparisons of the baseline with the follow-up values were performed using Non parametric Chi square test at all the evaluation periods. Two-sided comparative statistical tests were employed with a level of significance of 0.05.

Results: There were no adverse events or reactions occurred during study. There were no drop-outs in this clinical trial. The results of the air blast testing, as well as patient questionnaire data, confirm the hypotheses that NovaMin with or without fluoride will immediately relieve dentin hypersensitivity. Test Group I (NovaMin paste without Fluoride) participants experienced a 49% improvement in air blast responses. Test Group II (NovaMin paste with fluoride) a 43% improvement in air blast scores. Relief was also measured 2 weeks (14 days) after application.

At this time point,Test Group I participants experienced a 50% improvement in air blast responses. Test Group II experienced a 34% improvement in air blast scores. At both time points, the reduction in sensitivity was meaningful and significantly better than pretreatment (P< 0.05). Both NovaMin pastes were effective and there was no statistical difference between the pastes with and without fluoride.

There was no statistically significant difference (P>0.05) in the baseline scores of both the samples, thus nullifying the inter sampling discrepancy [Table 1] No statistically significant scores (P>0.05) were obtained between the groups when difference between baseline scores and after 2 min scores was taken into consideration [Table 2]. However in both the groups, we observed statistically significant differences when their baseline scores were compared with their after 2 min evaluation scores. No statistically significant difference observed in both groups after 15 days of evaluation. (P =>0.05) [Table 3].

 
TABLE-1 (VISUAL ANALOG SCORES PRIOR TO THE STUDY FOR BOTH THE GROUPS)
  moderate severe Total
Vantej 8 12 20
Sensodyne repair and protect 11 9 20

Pearson Chi-Square Value=0.902, dF=1 and P Value 0.342 (NS)

TABLE-2 (VAS FOR PAIN AFTER 2 MINUTE OF APPLICATION)
  No sensitivity Mild Moderate
Vantej 0 13 7
Sensodyne repair and protect 0 9 11

Pearson Chi-Square Value=1.616, DF=1 and P Value 0.204 (NS)

TABLE-3 (VAS sensitivity scores for both groups after 15 days period)
  No sensitivity Mild Moderate
Vantej 5 15 0
Sensodyne 4 16 0
DISCUSSION:

NovaMin is a relatively new material based on the bioactive glass originally used as bone graft material, and therefore is known to be highly biocompatible. Recently, it has been used for treating dentin hypersensitivity and known to occlude the open tubules by depositing hydroxycarbonate apatite, a mineral that is chemically and structurally similar to the mineral present in dentin and enamel.15, 16

As the material is subjected to an aqueous environment, the physical occlusion of Novamin particles begins. Hydrogen cations (H + or H 3 O + ) is immediately exchanged by sodium ions (Na + )present in the particles. This rapid release of ions allows calcium (Ca + ) and phosphate (PO 4 3- ) ions in the particle structure, released from the material. This initial series of reactions occurs within the seconds of exposure, and the release of the calcium and phosphate ions continues so long as the particles are exposed to an aqueous environment.15 This could also be explained due to the fact that when Calcium and Phosphate ions (existing in Novamin) are applied in conjunction with fluoride, their low solubility could lead to precipitation of these ions, which in turn could make it more difficult for these ions to reach the tooth surface .17

When considering patient benefits of this kind of care as opposed to risk, the history of both the product is well established. The occurrence of allergic reaction to both products is rare, and no reported incidence led to any adverse events in the present study. In addition, results from an extended 2-week treatment period of twice daily use of a toothpaste among 40 subjects provides further evidence of tolerability.18

References:
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  13. Schiff T, Doston M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a dentrifice containing potassium nitrate, soluble pyrophosate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity. A twelve week clinical study. J Clin Dent 1994; 5:87-92.
  14. Li Y, Lee S, Zhang YP, Delgado E, DeVizio W, Mateo LR. Comparisons of clinical efficacy of three toothpastes in reducing dentin hypersensitivity. J Clin Dent 2011; 22:113-20.
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