Randomised clinical studies investigating immediate and short-term efficacy of an occluding toothpaste in providing dentine hypersensitivity relief

Jonathan Creeth, John Gallob, Farzana Sufi, Jimmy Qaqish, Paola Gomez-Pereira, Chandrashekhar Budhawant, Chhaju Goyal, Jonathan Creeth, John Gallob, Farzana Sufi, Jimmy Qaqish, Paola Gomez-Pereira, Chandrashekhar Budhawant, Chhaju Goyal

Abstract

Background: Dentine hypersensitivity (DH) can occur after gum recession or enamel loss and may impact quality of life. Treatments include toothpastes that decrease DH by occluding dentine tubules. One effective occluding ingredient used in toothpastes is stannous fluoride (SnF2), but this can be unstable in aqueous formulation. These three studies aimed to characterise the short-term effects of an experimental, anhydrous SnF2 dentifrice on DH.

Methods: Three examiner-blind, parallel-group studies evaluated DH in participants with the condition after a single brushing and after 3d brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste (Test) or a toothpaste containing 0.76% sodium monofluorophosphate (Control). Test treatment participants brushed two pre-identified sensitive teeth first, then their remaining dentition for ≥1 min ('focused brushing'). Control treatment participants brushed their whole dentition for ≥1 min. DH was measured after single brushing and after 3d twice-daily use, via evaporative (air) (Schiff Sensitivity Scale) and tactile (Yeaple probe) stimuli and analysed using an ANCOVA model.

Results: In all studies, after 3d treatment, the Test toothpaste/brushing regimen significantly reduced DH compared to the Control regimen by both evaporative and tactile stimuli assessment (p < 0.0001 for all). The Test regimen also significantly reduced DH from baseline at both time-points by both measures in all studies (p < 0.0001 for all). Mean Schiff sensitivity score differences (95% confidence intervals) between Test and Control regimens after 3d were: Study 1: - 0.45 (- 0.577, - 0.319); Study 2: - 0.40 (- 0.505, - 0.300); Study 3: - 1.31 (- 1.500, - 1.128). Mean tactile score differences were: Study 1: 11.30 (7.927, 14.662); Study 2: 3.57 (2.531, 4.614); Study 3: 24.54 (20.349, 28.736). After single use, in Studies 2 and 3, the Test toothpaste/brushing regimen significantly reduced DH versus Control by both measures (p < 0.001 for all); in Study 1, treatment differences were not significant. Toothpastes were generally well-tolerated.

Conclusions: Taken together, these studies indicated focused brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste reduces DH compared to brushing with a conventional toothpaste after single use, with greater reduction after 3d.

Trial registration: Registrations at ClinicalTrials.gov : Study 1: NCT02832375 (registered 26.July.2016); Study 2: NCT02731833 (registered 26.April.2016); Study 3: NCT02923895 (registered 5.October.2016).

Keywords: Clinical trial; Dentin hypersensitivity; Tin fluorides; Toothpastes.

Conflict of interest statement

Jonathan Creeth, Farzana Sufi and Paola Gomez Pereira are employees of GSK Consumer Healthcare, who funded the study and developed the Test product that was the subject of this manuscript.

Silverstone Research, of whom John Gallob is an employee, All Sum Clinical Research, of whom Chhaju Goyal and Jimmy Qaqish are employees, and Syneos Health, of whom Chandrashekhar Budhawant is was an employee at the time of the study, have all received funding from GSK Consumer Healthcare.

Figures

Fig. 1
Fig. 1
Mean (± standard error) Schiff sensitivity scores (intent-to-treat population). Data are offset for clarity. BL: Baseline
Fig. 2
Fig. 2
Mean (± standard error) tactile threshold scores (intent-to-treat population). Data are offset for clarity. BL: Baseline

References

    1. Rimondini L, Baroni C, Carrassi A. Ultrastructure of hypersensitive and non-sensitive dentine. A study on replica models. J Clin Periodontol. 1995;22:899–902. doi: 10.1111/j.1600-051X.1995.tb01792.x.
    1. West NX, Lussi A, Seong J, Hellwig E. Dentin hypersensitivity: pain mechanisms and aetiology of exposed cervical dentin. Clin Oral Investig. 2013;17(Suppl 1):9S–19S. doi: 10.1007/s00784-012-0887-x.
    1. Brännström M. A hydrodynamic mechanism in the transmission of pain producing stimuli through dentine. In: Anderson DJ, editor. Sensory mechanisms in dentine. Proceedings of a symposium held at the Royal Society of Medicine, London, September 24th. Oxford: Pergamon Press; 1963. pp. 73–79.
    1. Addy M. Etiology and clinical implications of dentine hypersensitivity. Dent Clin N Am. 1990;34:503–514.
    1. Canadian Advisory Board on Dentin Hypersensitivity. Consensus-based recommendations for the diagnosis and management of dentin hypersensitivity. J Can Dent Assoc (Tor). 2003;69:221–226.
    1. Bekes K, Hirsch C. What is known about the influence of dentine hypersensitivity on oral health-related quality of life? Clin Oral Invest. 2013;17(Suppl 1):S45–S51. doi: 10.1007/s00784-012-0888-9.
    1. Gibson B, Boiko OV, Baker S, Robinson PG, Barlow A, Player T, et al. The everyday impact of dentine sensitivity: personal and functional aspects. Soc Sci Dent. 2010;1:11–20.
    1. Markowitz K. The original desensitizers: strontium and potassium salts. J Clin Dent. 2009;20:145–151.
    1. Bae JH, Kim YK, Myung SK. Desensitizing toothpaste versus placebo for dentin hypersensitivity: a systematic review and meta-analysis. J Clin Periodontol. 2015;42:131–141. doi: 10.1111/jcpe.12347.
    1. West NX, Seong J, Davies M. Dentine hypersensitivity. In: Lussi A, Ganss C, editors. Erosive tooth wear. Monogr Oral Sci 2014;25:108–122.
    1. Makin SA. Stannous fluoride toothpastes. Am J Dent. 2013;26:3A–9A.
    1. Mason S, Hughes N, Sufi F, Bannon L, Maggio B, North M, et al. A comparative clinical study investigating the efficacy of a toothpaste containing 8% strontium acetate and 1040 ppm fluoride in a silica base and a control toothpaste containing 1450 ppm fluoride in a silica base to provide immediate relief of dentin hypersensitivity. J Clin Dent. 2010;21:42–48.
    1. Hughes N, Mason S, Jeffery P, Welton H, Tobin M, O’Shea C, et al. A comparative clinical study investigating the efficacy of a test toothpaste containing 8% strontium acetate and 1040 ppm sodium fluoride versus a marketed control toothpaste containing 8% arginine, calcium carbonate, and 1450 ppm sodium monofluorophosphate in reducing dentinal hypersensitivity. J Clin Dent. 2010;21:9–55.
    1. Gendreau L, Barlow AP, Mason SC. Overview of the clinical evidence for the use of NovaMin in providing relief from the pain of dentin hypersensitivity. J Clin Dent. 2011:22;90–5.
    1. Pradeep AR, Sharma A. Comparison of clinical efficacy of a toothpaste containing calcium sodium phosphosilicate to a toothpaste containing potassium nitrate and to a placebo on dentinal hypersensitivity: a randomized clinical trial. J Periodontol. 2010;81:1167–1173. doi: 10.1902/jop.2010.100056.
    1. Nathoo S, Delgado E, Zhang YP, DeVizio W, Cummins D, et al. Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in New Jersey, USA. J Clin Dent. 2009;20:123–130.
    1. Ayad F, Ayad N, Delgado E, Zhang YP, DeVizio W, et al. Comparing the efficacy in providing instant relief of dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a benchmark desensitizing toothpaste containing 2% potassium ion and 1450 ppm fluoride, and to a control toothpaste with 1450 ppm fluoride: a three-day clinical study in Mississauga. Canada J Clin Dent. 2009;20:115–122.
    1. Schiff T, Delgado E, Zhang YP, Cummins D, DeVizio W, hypersensitivity MLRD. Effective treatment with an in-office desensitizing paste containing 8% arginine and calcium carbonate. Am J Dent. 2009;22:3A–7A.
    1. Fu Y, Li X, Que K, Wang M, Hu D, Mateo LR, et al. Instant dentin hypersensitivity relief of a new desensitizing toothpaste containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride: a 3-day clinical study in Chengdu, China. Am J Dent. 2010;23:20A–27A.
    1. West N, Newcombe RG, Hughes N, Mason S, Maggio B, Sufi F, et al. A 3-day randomized clinical study investigating the efficacy of two toothpastes, designed to occlude dentine tubules, for the treatment of dentine hypersensitivity. J Dent. 2013;41:187–194. doi: 10.1016/j.jdent.2012.11.007.
    1. He T, Barker MI, Biesbrock AR, Sharma N. A randomized controlled clinical trial to assess the desensitizing effect of a stannous fluoride dentifrice. Am J Dent. 2014;27(2):106–110.
    1. He T, Barker MI, Qaqish J, Sharma N. Fast onset sensitivity relief of a 0.454% stannous fluoride toothpaste. J Clin Dent. 2011;22:46–50.
    1. He T, Cheng R, Biesbrock AP, Chang A, Sun L. Rapid desensitizing efficacy of a stannous-containing sodium fluoride toothpaste. J Clin Dent. 2011;22:40–45.
    1. Parkinson C, Hughes N, Jeffery P, Jain R, Kennedy L, Qaqish J, et al. The efficacy of an experimental toothpaste containing 0.454% w/w stannous fluoride in providing relief from the pain of dentin hypersensitivity: an 8-week clinical study. Am J Dent. 2013;26:25A–31A.
    1. Miller S, Truong T, Heu R, Stranick M, Bouchard D, Gaffar A. Recent advances in stannous fluoride technology: antibacterial efficacy and mechanism of action towards hypersensitivity. Int Dent J. 1994;44(Suppl 1):83–98.
    1. Parkinson CR, Willson R. A comparative in vitro study investigating the occlusion and mineralization properties of commercial dentifrices in a four day dentine disc model. J Clin Dent. 2011;22:74–81.
    1. Schiff T, He T, Sagel L, Baker R. Efficacy and safety of a novel stabilized stannous fluoride and sodium hexametaphosphate toothpaste for dentinal hypersensitivity. J Contemp Dent Pract. 2006;7:1–10.
    1. Schiff T, Saletta L, Baker R, Winston JI, He T. Desensitizing effect of a stabilized stannous fluoride/sodium hexametaphosphate toothpaste. Compendium Cont Ed Dent. 2005;26:35–40.
    1. Parkinson CR, Hughes N, Hall NC, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride toothpastes for the relief of dentin hypersensitivity. Am J Dent. 2016;29:25–32.
    1. West NX, Seong J, Davies M. Management of dentine hypersensitivity: efficacy of professionally and self-administered agents. J Clin Periodontol. 2015;42(Suppl 16):S256–S302. doi: 10.1111/jcpe.12336.
    1. The Procter & Gamble Company. Oral care compositions which comprise stannous, potassium and monofluorophosphate. Patent WO2011016984 A2. Publication date 10 Feb 201.
    1. Glaxo group limited. Novel toothpaste composition. Patent WO2015028096 A1. Publication date 2015.
    1. Earl JS, Langford RM. Physical and chemical characterization of the surface layers formed on dentin following treatment with an experimental anhydrous stannous fluoride toothpaste. Am J Dent. 2013;26:19A–24A.
    1. Blong MA, Volding B, Thrash WJ, Jones DL. Effects of a gel containing 0.4 percent stannous fluoride on dentinal hypersensitivity. Dent Hyg (Chic) 1985;59:489–492.
    1. Miller JT, Shannon II, Kilgore W, Bookman JE. Use of a water-free stannous fluoride-containing gel in the control of dental hypersensitivity. J Periodontol. 1969;40:490–491. doi: 10.1902/jop.1969.40.8.490.
    1. Nehme M, Mason S, Hughes N, Targett D, Parkinson C, Tyson-Johnson D, et al. A randomized clinical study investigating the staining profile of an experimental stannous fluoride toothpaste. Am J Dent. 2013;26:32A–38A.
    1. Burnett GR, Willson RJ, Lucas RA. In vitro studies investigating the dentin tubule-occlusion properties of an experimental anhydrous stannous fluoride toothpaste. Am J Dent 2013;26(Spec No A):10A–14A.
    1. Burnett GR. The effect of an experimental anhydrous stannous fluoride toothpaste on the acid resistance of dentin smear layers. Am J Dent 2013b;26(Spec No A):15A–18A.
    1. Gallob J, Sufi F, Amini P, Siddiqi M, Mason S. A randomised exploratory clinical evaluation of dentifrices used as controls in dentinal hypersensitivity studies. J Dent. 2017;64:80–87. doi: 10.1016/j.jdent.2017.06.009.
    1. Holland GR, Narhi MN, Addy M, Gangarosa L, Orchardson R. Guidelines for the design and conduct of clinical trials on dentine hypersensitivity. J Clin Periodontol. 1997;24:808–813. doi: 10.1111/j.1600-051X.1997.tb01194.x.
    1. Schiff T, Dotson M, Cohen S, De Vizio W, McCool J, Volpe A. Efficacy of a toothpaste containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study. J Clin Den. 1994;5:87–92.
    1. Polson A. M., Caton J. G., Yeaple R. N., Zander H. A. Histological determination of probe tip penetration into gingival sulcus of humans using an electronic pressure-sensitive probe. Journal of Clinical Periodontology. 1980;7(6):479–488. doi: 10.1111/j.1600-051X.1980.tb02154.x.
    1. Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent. 1986;8:3–6.
    1. Laster L, Laudenbach KW, Stoller NH. An evaluation of clinical tooth mobility measurements. J Periodontol. 1975;46:603–607. doi: 10.1902/jop.1975.46.10.603.
    1. American Dental Association. Acceptance program guidelines: products for the treatment of dentinal hypersensitivity. American Dental Association, Council on Scientific Affairs, 2012.
    1. Benedetti F. Placebo and the new physiology of the doctor-patient relationship. Physiol Rev. 2013;93:1207–1246. doi: 10.1152/physrev.00043.2012.
    1. Addy M, West NX, Barlow A, Smith S. Dentine hypersensitivity: is there both stimulus and placebo responses in clinical trials? Int J Dent Hygiene. 2007;5:53–59. doi: 10.1111/j.1601-5037.2007.00228.x.
    1. West NX, Addy M, Jackson RJ, Ridge DB. Dentine hypersensitivity and the placebo response. A comparison of the effect of strontium acetate, potassium nitrate and fluoride toothpastes. J Clin Periodontol. 1997;24:209–215. doi: 10.1111/j.1600-051X.1997.tb01833.x.

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