|Year : 2020 | Volume
| Issue : 2 | Page : 87-91
Comparative evaluation of the efficacy of three commercially available toothpastes on dentin hypersensitivity reduction: an 8-week clinical study
Swathi Venkataramana1, Selva Kumar Jeyaraman1, Sai Sarath Kumar Kothimbakkam1, Burnice Nalina Kumari Chellathurai2
1 Department of Periodontics, Madha Dental College, Chennai, Tamil Nadu, India
2 Department of Periodontics, Meenakshi Ammal Dental College, Chennai, Tamil Nadu, India
|Date of Submission||04-Sep-2018|
|Date of Decision||09-Jul-2019|
|Date of Acceptance||07-Jan-2020|
|Date of Web Publication||21-May-2020|
Burnice Nalina Kumari Chellathurai
Meenakshi Ammal Dental College, Alapakkam Main Road, Chennai, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Objective: The objective of this 8-week, single-center, double-blind, three-cell, randomized, clinical study was to compare the efficacy in reducing the dentin hypersensitivity of three commercially available toothpaste: Group A toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate; Group B toothpaste containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride; and Group C toothpaste containing 5% potassium nitrate and 917 ppm fluoride as sodium monofluorophosphate. Materials and Methods: One hundred and fifty subjects, who reported to the department having teeth sensitive to tactile and air blast hypersensitivity, were assigned to one of the three study groups (50/group). Subjects were then asked to brush their teeth for 1 min, twice daily, with the given toothpaste. The dentin hypersensitivity of the two selected teeth was evaluated at baseline, 2 weeks, 4 weeks, and 8 weeks. Comparison of the treatment groups was conducted using the VAS analysis. Results: All 150 subjects complied with the protocol and completed the 8-week clinical study; there were no adverse events on the soft or hard tissues of the oral cavity. Group A resulted in more improvement in the reduction of sensitivity at 2, 4, and 8 weeks compared to the other groups. Conclusions: Group A toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate significantly reduces dentin hypersensitivity and more effective than Group B and Group C toothpaste. Group A toothpaste is the latest new tool in the armament of the modern dentist.
Keywords: Air blast sensitivity, dentin hypersensitivity, tactile sensitivity, visual analog scale analysis
|How to cite this article:|
Venkataramana S, Jeyaraman SK, Kumar Kothimbakkam SS, Kumari Chellathurai BN. Comparative evaluation of the efficacy of three commercially available toothpastes on dentin hypersensitivity reduction: an 8-week clinical study. Indian J Dent Sci 2020;12:87-91
|How to cite this URL:|
Venkataramana S, Jeyaraman SK, Kumar Kothimbakkam SS, Kumari Chellathurai BN. Comparative evaluation of the efficacy of three commercially available toothpastes on dentin hypersensitivity reduction: an 8-week clinical study. Indian J Dent Sci [serial online] 2020 [cited 2020 May 28];12:87-91. Available from: http://www.ijds.in/text.asp?2020/12/2/87/284672
| Introduction|| |
Dentin hypersensitivity is a commonly experienced clinical problem and is characterized by short, sharp burst of pain arising from exposed dentin in response to external stimuli; these stimuli are most commonly of a tactile, evaporative, thermal, osmotic, chemical, or dehydrating nature, which cannot be ascribed to any other dental pathology or defects., The diagnosis of dentin hypersensitivity can be challenging for the dental professional. They must perform differential diagnosis in order to exclude all other dental diseases and defects that might give rise to similar presentations, such as broken tooth, or dental caries, or periodontal disease. It is important to develop correct diagnosis and implement the treatment plan appropriately.
Gingival recession which results from abrasion or periodontal disease is the primary predisposing factor through which the underlying dentin becomes exposed, a secondary factor being cervical enamel loss. An important factor in opening the exposed dentinal tubules is acid erosion.,,, Dentin hypersensitivity occurs, when any external stimulus, such as tactile pressure, thermal or air movement contact the exposed dentin which in turn triggers the dentinal fluid to flow out rapidly, can cause immediate pain or discomfort to the patient.
The immediate pain or discomfort of dentin hypersensitivity varies from a minor to major inconvenience that can provoke emotional distress and chronic discomfort to the patient. As the maintenance of normal hygiene becomes more difficult, due to the increased accumulation of dental plaque leads to gingival recession, dental caries formation, gingivitis, and further periodontitis.
The theory that is widely accepted for dentin hypersensitivity-related pain is the “hydrodynamic theory” proposed by Brännström and Astron. Two simple clinical methods used for diagnosing dentin hypersensitivity include “air blast” or evaporative method and tactile method using an exploratory probe in a mesiodistal direction on the exposed dentinal tubules. The degree or severity of pain can be reported either according to a visual analog scale (VAS) or using the categorical scale (i.e., slight, moderate, or severe pain).
The dentin hypersensitivity is typically managed by the products to control the hydrodynamic mechanisms of pain. There are two discrete technical approaches to control dentin hypersensitivity: in the first approach, agents or products that occluding the tubules that reduce fluid flow within the dentin tubules by themselves, thereby blocking the stimuli, and the second approach is to interrupt the neural response to stimuli.
Prevalence and epidemiology
Dentin hypersensitivity is a painful oral condition typically experienced by young-to-middle-aged adults. Dentin hypersensitivity has reported levels of an incidence ranging from 4% to 74%.,,,, The most commonly affected age group ranges from 20 to 50 years, with peak age between 30 and 40 years. Dentin hypersensitivity can affect patients of any age group. Regarding the type of teeth involved, the most affected teeth of both the arches are canines and premolars. The commonly affected site is the cervical area of buccal aspect.
| Materials and Methods|| |
After the institutional review board approval of the protocol and the letter of informed consent, a total of 150 healthy subjects, ages of 19–68 years, participated in the clinical study. Subjects were required to sign the informed consent form and to be available for the duration of the study, For each subject who eligible for participation in the study should have dentin hypersensitivity with minimum of two teeth that satisfied the tactile and air blast hypersensitivity among incisors, canines, premolars, and molar with cervical abrasion/erosion or gingival recession, as determined by a tactile and air blast hypersensitivity was reported according to VAS (visual analog scale score analysis).
The study was a three-cell, single-center, double-blind, and randomized clinical investigation. Each enrolled participant of this clinical study was assigned randomly to one of the three dentifrice groups that were balanced using the baseline air blast and tactile hypersensitivity scores along with an oral soft and hard tissue assessment. The three toothpastes studied were as follows:
- Group A: Containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate
- Group B: Containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (NaF)
- Group C: Containing 5% potassium nitrate and 917 ppm fluoride as sodium monofluorophosphate.
Following treatment assignment, subjects were provided with their assigned dentifrice and advised to use a soft-bristled toothbrush. All dentifrices were supplied to the subjects in overwrapped tubes to mask the identity of the product to ensure the double-blind design. All clinical supplies were refurbished as needed. A lognote of the dispensed dentifrices was kept. Instructions to the subjects at home included brushing their teeth for 1 min, twice daily, using only the toothpaste provided throughout the duration of the study. Subjects returned to the clinic after 2 weeks, 4 weeks, and 8 weeks to their scheduled examinations. Oral tissue assessments and tactile and air blast dentin hypersensitivity were repeated by the same examiner using the same methods as employed at baseline. There were no other restrictions during the study regarding diet or smoking habits. Subjects were requested to return to the clinical department to their scheduled visit throughout the duration of the study.
- Subjects had to be between the ages of 19 and 68 years (inclusive), in generally good health with no history of allergies
- Subjects were required to possess a minimum of two hypersensitive teeth and demonstrated cervical erosion/abrasion or gingival recession
- The depth of dentin loss should be <1 mm, which does not require any restorative procedures
- Subjects were required to be available for the 8-week duration of the study and to sign informed consent form.
Before starting the treatment, baseline sensitivity values were recorded using the air blast stimuli and tactile method.
- Individuals who had chronic disease, gross oral pathology
- Advancing periodontal disease and the treatment for the periodontal disease within 1 year
- Hypersensitive teeth with Grade 2 mobility
- Individuals who were participating in any other clinical study, or who had participated in a desensitizing study, or who used any desensitizing agents within the previous 3 months were not allowed to participate in the study
- Subjects with a history of allergy to the test products or subjects with existing medical conditions were also excluded from the study
- Teeth which had dental caries, cracks, or fractures in the cervical areas of the teeth
- Teeth with any extensive or unsatisfactory restorations, prostheses, or orthodontic appliances which involved the cervical areas
- Pregnant or lactating women
- Subjects with a history of drug addictions and use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, and analgesic and anti-inflammatory drugs
- Nonvital teeth
- Subjects who failed to give their consents.
Patients who failed to complete the follow-up after undergoing initial treatment.
Tactile sensitivity assessment
Tactile hypersensitivity was assessed by instructing the subject to respond at the point where he/she 1st experienced discomfort. The explorer tip was applied to the buccal surface of each hypersensitive tooth at the cementoenamel junction. The explorer tip was stroked by a single dental examiner perpendicular to the tooth under slight manual pressure on the hypersensitive areas of the tooth. The degree of hypersensitivity was recorded according to VAS analysis. A 10-cm sensitivity VAS score is given; VAS score had ratings from 0 to 1 for no pain, 2–3 for mild pain, 4–6 for moderate, and 7–10 for severe pain. Subjects with baseline values ≥4 on VAS were included in the study.
Air blast sensitivity assessment
Teeth were evaluated for air blast hypersensitivity by isolating the hypersensitive tooth from the adjacent teeth (both on the mesial and distal) by placing the examiner's fingers over the adjacent teeth. 1–2 s blast of air was delivered from a standard dental unit air syringe at 40 psi (±5 psi), and the air was directed at the exposed buccal surface of the hypersensitive tooth for 1 s from a distance of approximately 1 cm. The degree of hypersensitivity was recorded according to VAS analysis. A 10-cm sensitivity VAS score is given; VAS score had ratings from 0 to 1 for no pain, 2 to 3 for mild pain, 4–6 for moderate, and 7–10 for severe pain. Subjects with baseline values ≥4 on VAS were included in the study.
All statistical analyses were performed using Statistical Package for the Social Sciences (IBM SPSS® Statistics version 17) for Microsoft windows. The data were normally distributed. And therefore, parametric tests were performed. Descriptive statistics were presented as numbers and percentages. The data were expressed as mean and standard deviation.
A one-way analysis of variance with a post hoc Tukey's honestly significant difference (HSD)/Kruskal–Wallis test was used for normally distributed continuous data. Paired sample's test/Wilcoxon signed–rank test were used for ordinal data into within groups. Chi-squared test was used for comparison between the two attributes. A two-sided P < 0.05 was considered statistically significant.
| Results|| |
All one-hundred and fifty subjects complied with the protocol and completed the 8-week clinical study. A summary of the gender and age of the study population is presented in [Table 1]. Throughout the study, there were no adverse events on the soft or hard tissues of the oral cavity observed by the examiner or reported by the subjects when questioned. [Table 2] and [Figure 1] presents a summary of the mean VAS scores for tactile and air blast hypersensitivity measured at the baseline, 2 weeks, 4 weeks, and 8 weeks examination. For air blast and tactile hypersensitivity, the mean values at baseline, 2 weeks, 4 weeks, and 8 weeks were 7.58, 7.43, 5.58, and 3.96 for Group A;, 7.56, 7.36, 6.24, and 5.03 for Group B; and 7.74, 7.58, 6.54, and 5.67 for Group C. No statistically significant differences were indicated among the treatment groups with respect to either tactile or air blast hypersensitivity scores at baseline. Group A resulted in more improvement at 2 weeks, 4 weeks, and 8 weeks compared to the other groups.
|Table 1: Summary of age and gender for subjects who completed the 8-week clinical study|
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|Table 2: Sensitivity scores to air and tactile stimulus for all groups at baseline, 2 weeks, 4 weeks, and 8 weeks|
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|Figure 1: Mean tactile and air blast hypersensitivity scores at baseline, first visit, second visit, and third visit, with the following Group A, Group B, and Group C toothpastes|
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[Table 3] presents a summary of intragroup comparison (baseline vs. comparisons) of the air blast and tactile hypersensitivity scores measured after 2 weeks, 4 weeks, and 8 weeks of product use, with the P value of all groups recorded a significant improvement from baseline to 2 weeks, from baseline to 4 weeks, and from baseline to 8 weeks. [Table 4] presents a summary of comparison between treatment groups of air and tactile stimulus, with the P value at baseline, 2 weeks, 4 weeks, and 8 weeks groups showing the intergroup comparison.
|Table 3: Intragroup comparison of air and tactile scores between different visits|
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|Table 4: Intergroup comparison of air and tactile stimulus at baseline, 2 weeks, 4 weeks, and 8 weeks|
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Using ANOVA, i.e. Kruskal–Wallis test, no significant difference between groups at baseline and 2 weeks was found for both air and tactile stimulus. For air stimulus, there was a significant difference between 4 weeks and 8 weeks at P < 0.001.
Using post hoc test, i.e. multiple comparison Tukey's HSD, there was a significant difference between Group A versus B and C, but there was no significant difference between Group B and Group C. In 8 weeks, there was significant difference between Group A versus B and C and Group B and Group C also significant for both air and tactile stimulus.
| Discussion|| |
This double-blind clinical study provided an investigative comparison of the efficacy of three commercially available toothpastes with respect to dentin hypersensitivity reduction after 2, 4, and 8 weeks of at-home brushing, two times per day over an 8-week period.
Dentifrices of their low cost and ease of use for home brushing that have been used in the treatment of dentin hypersensitivity. The mechanism of action of a desensitizing toothpaste is either the obliteration of dentin tubules on the dentinal surface by the precipitation of insoluble deposits or nerve depolarization (potassium-based toothpaste) when potassium-based toothpastes are used for several weeks, reported to alleviate the discomfort associated with hypersensitivity. Although among dental professionals, wide popularly used potassium-based products efficacy is still open to question.
The present clinical study compared Group A to Group B and Group C dentifrices, determining their clinical effectiveness in the reduction of dentin hypersensitivity after 2, 4, and 8 weeks of brushing their teeth twice daily. Compared to the Group B and Group C, subjects related to the Group A toothpaste showed better efficacy, providing statistically significantly reduction in the air blast hypersensitivity scores after 2nd weeks (0.905 and 0.634, respectively), 4th weeks (0.037 and 0.000, respectively), and 8th weeks (0.000 and 0.000, respectively).
The superior and better efficacy of Group A was confirmed by the tactile sensitivity test results. Compared to the Group B and Group C, subjects related to the Group A toothpaste providing statistically significantly reduction in tactile hypersensitivity scores after 2nd weeks of brushing their teeth twice-daily (0.905 and 0.634, respectively), 4th weeks (0.037 and 0.000, respectively), and 8th weeks (0.000 and 0.000, respectively).
The results demonstrated a reduction in symptoms for all treatment groups from baseline to 2, 4, and 8 weeks for both measures of sensitivity. There was a remarkable pattern toward the reduction of dentin hypersensitivity with time for all the variables during the 8 weeks of the active phase of the study independent of treatment groups. [Table 1] shows gender and age of the study population. [Table 2] shows the mean scores for tactile and air blast stimulus measured at the baseline, 2 weeks, 4 weeks, and 8 weeks examination. [Table 3] shows baseline versus comparison of the groups. [Table 4] shows comparison between treatment groups of air and tactile.
The Group A showed a higher degree of effectiveness at reducing dentin hypersensitivity than Group B and Group C for both sensitivity measures. There was no statistically significant difference between the results of Group B toothpaste and Group C toothpaste in the reduction of symptoms at the end of 8 weeks. Some studies have reported the effectiveness of 8% arginine as an active ingredient, unlike other products. According to Cummins, Docimo et al., Li et al., and Patel et al., 8% arginine offers a significant relief of dentin hypersensitivity.
The unique difference in the present study is that we have included all the teeth in the oral cavity having a minimum of two teeth with dentin hypersensitivity among incisors, canines, premolars, and molar with cervical erosion/abrasion or gingival recession, but the previous study reported only to teeth anterior to the molars. Hence, that molars also have an incidence of dentin exposure compared to other teeth in the oral cavity; therefore, molars should not left when examining the teeth for dentin hypersensitivity.
| Conclusions|| |
Group A toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate used twice daily significantly reduces dentin hypersensitivity and is significantly more effective than Group B toothpaste containing 8% strontium acetate and 1040 ppm fluoride as NaF and Group C toothpaste containing 5% potassium nitrate and 917 ppm fluoride as sodium monofluorophosphate. Group A toothpaste is the latest new tool in the armament of the modern dentists.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]