Dataset Information

Comparative efficacy of BioMin-F, Colgate Sensitive Pro-relief and Sensodyne Rapid Action in relieving dentin hypersensitivity: a randomized controlled trial.

ABSTRACT:

Background

Dentin hypersensitivity (DH) is a sharp toothache that influences a patients' oral health-related quality of life. Oral dentifrices have been marketed for pain relief within a minute for DH. The permanent management of DH is being investigated with the remineralisation potential of bioactive agents in dentinal tubules. This study investigated the relief from pain in DH in one minute after applying over the counter (OTC) dentifrices with Pro-Argin™ and strontium acetate and directly compared them with fluoro-calcium phospho-silicate (FCPS)-based dentifrices for immediate and sustained inhibition of painful stimulus provoking DH.

Methods

A randomised, controlled, triple-blinded clinical trial was conducted with 140 participants clinically diagnosed with DH and equally randomized into four groups with parallel treatment assignment of FCPS, Pro-Argin™, 8% strontium acetate, and sodium fluoride-based OTC dentifrices, and tested for DH with air blast, mechanical, and water jet stimuli on SCHIFF cold air sensitivity scale (SCASS) and visual analogue scale (VAS) at interim efficacy intervals of one minute, three days, two, four, and six weeks, subsequently.

Results

A total of 128 participants completed the trial. All the treatment groups showed statistically significant improvement in DH with p < 0.001 relative to baseline at all time points. Pro-Argin™ showed a greater reduction in DH with mean scores of (1.34 ± 0.68) (4.20 ± 1.70) (3.05 ± 2.17) followed by strontium acetate (1.57 ± 0.81) (4.65 ± 1.87) (3.75 ± 1.97) on SCASS and VAS for mechanical and water jet stimuli, one minute after application. There was no statistically significant treatment difference between the two (p = 0.499). FCPS showed the highest reduction in DH on SCASS and VAS for waterjet stimuli with mean scores of (0.97 ± 0.68) (1.80 ± 1.73) and Pro-Argin™ on VAS for mechanical stimuli with mean scores of (2.15 ± 1.92) in six weeks.

Conclusion

OTC dentifrices with Pro-argin™ and strontium acetate are effective for immediate pain relief from DH, and FCPS could be the best possible treatment option for long term management of DH.

Trial registration

ID: NCT04249336 ( https://clinicaltrials.gov/ct2/show/NCT04249336 ), Date of Registration: January 30, 2020 (Retrospectively registered).

SUBMITTER: Arshad S

PROVIDER: S-EPMC8493541 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectivesTo compare the effectiveness of using a 0.454% stannous fluoride-containing dentifrice twice daily in relieving dentinal hypersensitivity (DH) in a Chinese population.Materials and methodsThis was a single-centre, randomized, controlled, examiner-blind, three-treatment-arm, parallel-group study in participants with clinically diagnosed DH. Subjects who met inclusion criteria (n = 197) were randomly allocated into 3 groups: test group (n = 66)-using a 0.454% stannous fluoride-containing dentifrice twice daily; positive control group (n = 64)-using a 5.0% calcium sodium phosphosilicate-containing dentifrice twice daily; negative control group (n = 67)-using a 1150 ppm of NaF dentifrice twice daily. Status of DH was assessed at week 4 and week 8 by the same independent examiner. Changes from baseline in Schiff sensitivity score, tactile threshold and Dentine Hypersensitivity Experience Questionnaire (DHEQ) score were analysed using analysis of covariance models. The DHEQ evaluated subject-perceived oral health-related quality of life (OHRQoL).ResultsStatistically significant improvements in mean Schiff scores (p < 0.0001 for all products at Weeks 4 and 8), tactile threshold (p < 0.0001 for test and negative control at Weeks 4 and 8: Week 4 p = 0.0040 and Week 8 p < 0.0001 for positive control) and all DHEQ scores (p < 0.01 for all groups) were observed. No statistically significant differences were observed in the adjusted mean between all dentifrices at both timepoints, potentially driven by a placebo effect. Forty-two treatment-emergent adverse events (TEAEs) were reported (n = 32 subjects), with 2 serious AEs (n = 1) in the test group. TEAEs were not considered treatment-related.ConclusionsAll groups demonstrated statistically significant improvements in Schiff score, tactile threshold and OHRQoL. However, due to a possible placebo effect in the negative control, there were no statistically significant differences between the dentifrices.Clinical relevanceThis study adds to the growing research exploring why the placebo effect is a common phenomenon in DH studies.Trial registrationClinicalTrials.gov Identifier: NCT04950465.

Project description:BackgroundDentine 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.MethodsThree 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.ResultsIn 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.ConclusionsTaken 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 registrationRegistrations at ClinicalTrials.gov : Study 1: NCT02832375 (registered 26.July.2016); Study 2: NCT02731833 (registered 26.April.2016); Study 3: NCT02923895 (registered 5.October.2016).