Enhancing Fluoride Mediated Dentine Sensitivity Relief through Functionalised Tricalcium Phosphate Activity

Abstract

Background. To assess the clinical efficacy of a dentifrice containing fluoride and functionalised tricalcium phosphate (fTCP) in reducing dentine sensitivity. Methods. A 10-week parallel blind randomised control trial was conducted. Subjects were assigned to one of four groups and instructed to brush twice daily: A: Colgate Cavity Protection (1000 ppmF-MFP); B: Sensodyne Total Care (1000 ppmF-NaF + 19300 ppmK+-KNO3); C: Clinpro Tooth Crème (950 ppmF-NaF + fTCP); and D: Clinpro Tooth Crème (brushing + additional topical application). Seventy-one patients were assessed at baseline, 6 weeks, and 10 weeks for cold, tactile, and hypertonic sensitivity using the NRS-11 pain rating scale. A combined modalities sensitivity score (CMS) was calculated. Results. At 6 weeks, patients reported the following reduction in CMS: A (20%); B (30%); C (42%); D (52%). At 10 weeks, patients reported the following reduction in CMS: A (18%), B (40%), C (24%), and D (54%). The only CMS comparisons to show a significant difference (P < 0.05) were between Groups A and D (6 and 10 weeks). Conclusions. Addition of fTCP to a dentifrice enhances the ability of dentifrice fluoride in reducing dentine sensitivity. Using Clinpro Tooth Crème twice daily for brushing can be as effective to reduce dentine sensitivity as twice daily brushing using Sensodyne Total Care. However, additional nightly topical application of fTCP, in addition to twice daily brushing, showed an enhanced reduction in dentine sensitivity.

Clinical Trial Designs for the Testing of OTC Products for Dentine Hypersensitivity-A Systematic Review

“…Other studies used a randomisation process involving a lottery method to allocate participants to the various groups [33], or used a computer-generated random table to ensure double blinding during the study [37] as well as using a list of random numbers sequentially from a Sponsor's Biostatistics Unit [38,[43][44][45][49][50][51]. The study by Naoum, et al [46] used a computer algorithm to limit the impact of age, gender, diet, and current level of oral hygiene on the study. The methodology used to maintain blinding during the study was not always clearly described in the studies, but it would be normal practice to overwrap the test and control dentifrices or have similar tubes/mouth rinses with labels with the assigned code (allocation concealment or masking) [18,33,37,38,43,50,51].…”

“…All the included studies meet the guidelines in relation to the study duration ranging from six to 12 weeks (assessment at baseline, mid-point, end-point assessment). There were five studies of six weeks duration [24,30,33,36,48], one study of 10 weeks duration [46] two studies over 12 weeks duration [27,43] and 27 of studies of eight weeks duration [17][18][19][20][21][22][23][25][26]28,29,31,32,34,35,[37][38][39][40][41][42]44,45,47,[49][50][51].…”

“…33466 participants were enrolled in the included studies and included both male and female participants with an age range from 18-70 years. Most of the included studies (91%; n=32) included at least 25 subject per arm, three studies [17,32,46], included less than 25 per arm. Only 12 studies provided information on any power calculation (formally or informally), for example to detect statistically significant differences between treatment groups using a two tailed alpha 0.05 and a power of 80% [30][31][32][33]36,39,[44][45]47,[49][50][51].…”

“…Most studies indicated a twice daily brushing with the assigned dentifrice although some studies did not specify for how long, but the assumption would be one minute twice daily [17][18][19][20][21][22][23][24][25][26][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][47][48][49][50][51]. The exception to the one-minute brushing regime was the studies by Wara-aswapati, et al [27] and Naoum, et al [46] where the participants were asked to brush twice daily for two minutes. There were five mouthwash studies where the participants were asked to brush their teeth for one-minute with or without a toothpaste prior to rinsing with their allocated mouthwash for one-minute (twice daily) [18,24,38,40,48].…”

“…periodontal probe) with an air blast [27,28,30,31,33,37,43,48]. Naoum, et al [46] used a combination of tactile (explorer probe), air blast and a 70% hypertonic sucrose solution. Eight (22.8%) of the included studies (included a subjective evaluation of the participants' overall sensitivity to everyday stimuli [19,24,34,39,41,42,50,51].…”