Shanna Amann

Summary

4/10/14

The Effect of Calcium Sodium Phosphosilicate on Dentin Hypersensitivity Dentinal hypersensitivity is a commonly encountered problem with varied treatment options for its management. A large number of home use products have been tested and used for the management of dentinal hypersensitivity. This 8 week clinical trial investigates the temporal efficacy of commercially available calcium sodium phosphosilicate containing toothpaste in comparison to a potassium nitrate containing toothpaste. A total 20 subjects between the ages of 18 to 65 years were screened for a visual analogue score (VAS) for sensitivity of 5 or more by testing with a cold stimulus and randomly divided into test and positive control groups. Baseline sensitivity VAS scores to air evaporative stimulus were recorded for minimum two teeth. The subjects were prescribed respective dentifrices and revaluated for sensitivity scores at 2, 4 and 8 weeks. The study demonstrated reduction in symptoms for all treatment groups from baseline to 2, 4 and 8 weeks. The calcium sodium phosphosilicate group showed a higher degree of effectiveness at reducing hypersensitivity to air evaporative stimulus at 2 weeks, than commercially available potassium nitrate. However, there was no significant difference in scores of subjects using the calcium sodium phosphosilicate toothpaste as compared to potassium nitrate at 4 weeks and 8 weeks. Calcium sodium phosphosilicate showed greater reduction in sensitivity compared to potassium nitrate at an earlier stage which is of high clinical value. However, based on the findings of the present study long term effects of calcium sodium phosphosilicate seem to be less promising than previously claimed.

Dental hypersensitivity is a growing problem among our society that is very uneducated by most civilians. Dental hypersensitivity is a painful condition of the permanent teeth in which dental pain is sharp in character and of short duration, arising from exposed dentin surfaces in response to stimuli. The hydrodynamic theory explains that the movement of dentinal fluid on stimulation with thermal, chemical, evaporative or electric stimulus is responsible for the excitation of the underlying dentinal mechanoreceptor resulting in sensitivity. Many forms of treatment have been tested to control some of this sensitivity, such as mouthwashes, tray application foams, varnishes, liners, restorative materials, dentinal adhesive iontophoresis procedures, as well as laser treatments. Generally speaking, most patients who suffer from dental hypersensitivity choose to treat with over the counter products with at home application because they are cost effective, convenient, widely available, and simple to use. Doctors are continually working to develop products that fit these guidelines. Doctors have tested potassium nitrate, which contains dentifrices; have consistently shown benefit in alleviating hypersensitivity symptoms in 8-12 weeks. These dentifrices work by blocking the neural transmission. NovaMin, another form of dental hypersensitivity treatment, was developed in the 1990s as a modification of bioglass. This product reacts with the tooth dentin in small particles by gaining access to the dentinal tubules. These particles release mineral ions of calcium and phosphate that augment the natural remineralization process when exposed to fluid. The calcium phosphate will then crystalize into hydroxycarbonate apatite to form a layer that results in the physical occlusion of dental tubules, relieving hypersensitivity. Further testing is needed to compare the temporal effectiveness of a calcium sodium phosphosilicate containing toothpaste with potassium nitrate containing toothpaste. The two different toothpastes being compared in this study both consisted of a non-aqueous mixture; one containing 5 percent calcium sodium phosphosilicate, and one containing 5 percent potassium nitrate. The test conducted was to compare results in hypersensitivity reduction. A single
2

center, randomized, double blind and parallel group clinical trial was used as part of the testing method. The double blinding procedure was to ensure the elimination of subject bias to either of the products. The brand names from the tubes were painted over with a uniform color by a third person. The clinical trial lasted 8 consecutive weeks with measurements at baseline, 2 weeks, 4 weeks, and at 8 weeks. Patients were required to be diagnosed with Dental Hypersensitivity, have at least two sensitive permanent tooth surfaces (buccal/facial) aspects of incisors, canines or premolars), a grading of a 5 or more of at least 2 teeth on the VAS scale, no history of periodontal therapy within one year of the trial, and of the age of 18 to 65. Sensitive tooth surfaces were selected if they had wasting disease and/or gingival recession. Patients were excluded from the study if they were presently on desensitizing treatment, had orthodontic appliances or bridgework that may interfere with evaluation, medical histories that may compromise study protocol (including psychiatric and pharmacotherapeutic), had allergies to the medication or any other substances being used, system conditions which are etiologic predisposing to dentinal hypersensitivity, any subjects with dental treatment which may have an effect on the desensitizing agent being used, had an eating disorder, or were breast feeding or pregnant. Each subject admitted into the study had a tooth sensitivity assessment. To assess sensitivity, a cold pack test of sensitive areas was performed using ice application. Sensitivity was measured using a 10 cm visual analog scale (VAS) score. On the VAS scale, 0cm was a no-pain response, 5cm was perceptible discomfort, and a score of 10cm being extreme pain or discomfort. Patients were designated into 2 different study groups. Group 1 received the toothpaste (tube painted red) containing 5 percent calcium sodium phosphosilicate while Group 2 received the toothpaste containing 5 percent potassium nitrate (tube painted black).

Each chosen tooth was further scored and recorded at VAS baseline by using controlled air pressure from a dental syringe, ambient temperature, perpendicularly at a distance of 1 to 3 mm from the exposed dentin surface of the test teeth. The surrounding teeth were protected with gloved fingers. Periodontial therapy (scaling) was instituted for all the subjects and patients were provided with the respective dentifrices. Assessments were again taken at 2 weeks, 4 weeks, and 8 weeks. The instructions to the patients, after being separated into test groups, were to brush for 5 minutes twice a day throughout the period of their study trial, and were asked to remain from consuming very hot, cold, sweet, or sour food or drinks. Subjects were also directed to refrain from any other dentifrices or mouth rinse during the trial, but were allowed to continue their normal oral hygiene practice. Individual VAS scores were calculated from each treatment group. Mean scores were compared between the two groups at baseline at week 2, week 4, and week 8. Mean scores of One Way Analysis of Variance (ANOVA) at 2 weeks, 4 weeks, and 8 weeks were compared to find out the difference between the test and control group with baseline scores. The data of test and control group were compared between 2 weeks, 4 weeks, and 8 weeks using Analysis of Co-variance (ANCOVA) with baseline as covariate. The percentage reduction from baseline at 2 weeks, 4 weeks, and 8 weeks was compared between the two groups using students unpaired t-test. The ANOVA of baseline sensitivity indicated no significant difference effects between the groups for air evaporative stimulus. These scores were used as a covariate because of the similarity. Significant improvement compared to baseline showed the reduction in dentin hypersensitivity over time for both Group 1 and Group 2. The percentages of reduction in hypersensitivity for group 1 were 40.34 at week 2, 57.98 at week 4, and 75.63 at week 8. The percentages of reduction in hypersensitivity for group 2 were 24.79 at week 2, 47.86 at week 4, and 64.96 at week 8. A significant

difference among groups showed after two weeks, but no significant difference of reduction of scores between the two groups. NovaMin provided relief of pain from dentin hypersensitivity in this trial as well as in other trials and has been supported as a pain relief agent for dentin hypersensitivity. Both of the groups in this clinical study showed reduction in dentin hypersensitivity, with the calcium sodium phosphosilicate group showing a higher degree of effectiveness at reducing hypersensitivity overall and at an earlier stage than the potassium nitrate for hypersensitivity. Group 1 overall showed a higher decrease with hypersensitivity than Group 2, but no significant difference was found between the two groups at week 4 and at week 8, which the dentifrice being used as the delivery method could be the determining factor. The potassium nitrate (positive control) was found to be as effective as the calcium sodium phosphosilicate after 4 and 8 weeks. The conclusion of this test is that the calcium sodium phosphosilicate toothpaste is a faster relieving product for dentin hypersensitivity compared the potassium nitrate toothpaste. The long term effects of calcium sodium phosphosilicate toothpaste seem to be less promising than the hypothesis. Acharya, Airudh B., Sai M. Surve, and Srinath L Thakur. "A Clinial Study of the Effect of Calcium Sodium Phoshosiliate on Dentin Hypersensitivity." Scopus. 10.50955 (2012): 18-22. Print.