Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin®) in providing rapid dentine hypersensitivity relief

John Gallob; Martin R. Ling; Pejmon Amini; Avinash Patil; Mounir Atassi

doi:10.1016/j.jjodo.2019.100003

Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin^®) in providing rapid dentine hypersensitivity relief

John Gallob, Martin R. Ling, Pejmon Amini, Avinash Patil, Mounir Atassi^* (Corresponding Author)

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin^®) in providing rapid relief from dentine hypersensitivity (DH). Methods: In this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10 min, 2 h and 4 h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. Results: At 10 min post-application, mean Schiff score change from baseline (primary endpoint) was statistically significant with the Test strip (−0.46; 95% confidence intervals [CI]: −0.563, −0.356; p < 0.0001) but not with No treatment (−0.02; 95% CI: −0.119, 0.088; p = 0.7664). The between-treatment group difference favored the Test strip (difference: −0.44; 95% CI: −0.591, −0.297; p < 0.0001). Similar improvements with the Test strip were reported for all other evaporative (air) and tactile sensitivity endpoints (p < 0.0001 vs no-treatment) at all timepoints (10 min, 2 h, 4 h). Test strips were considered by most staff and participants slightly/moderately easy to apply (98%). Many participants rated the overall usage experience as “like moderately” (40%) or “like extremely” (20%). There were no treatment-related adverse events. Conclusion: This new CSPS-based technology may provide a novel treatment option for rapid relief from DH (Clinicaltrials.gov NCT02937623). Clinical significance: A dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) demonstrated significantly greater dentine hypersensitivity reductions following a single application compared with no treatment. Strips were well-liked by participants and generally well tolerated. A strip containing CSPS, which dissolves within 10 min, may provide rapid relief from dentine hypersensitivity.

Original language	English
Article number	100003
Number of pages	6
Journal	Journal of Dentistry
Volume	91
Issue number	Supplement
DOIs	https://doi.org/10.1016/j.jjodo.2019.100003
Publication status	Published - 12 Jul 2019
Externally published	Yes

Bibliographical note

This study was funded by GSK Consumer Healthcare, Weybridge, Surrey, UK of which Martin Ling and Mounir Atassi are employees. John Gallob is an Independent Contractor to, and Pejmon Amini is an employee of, Silverstone Research Group; Avinash Patil was an employee of Syneos Health at the time of the study. Silverstone Research Group and Syneos Health have received funding from GSK Consumer Healthcare.

Data Availability Statement

No data availability statement

Keywords

Calcium sodium phosphosilicate
Clinical trial
Dentine hypersensitivity
Dissolvable strip
Occlusion

Access to Document

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Cite this

@article{aafa8674be034ce5a0da14208d599efc,

title = "Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin{\textregistered}) in providing rapid dentine hypersensitivity relief",

abstract = "Objective: To evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin{\textregistered}) in providing rapid relief from dentine hypersensitivity (DH). Methods: In this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10 min, 2 h and 4 h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. Results: At 10 min post-application, mean Schiff score change from baseline (primary endpoint) was statistically significant with the Test strip (−0.46; 95% confidence intervals [CI]: −0.563, −0.356; p < 0.0001) but not with No treatment (−0.02; 95% CI: −0.119, 0.088; p = 0.7664). The between-treatment group difference favored the Test strip (difference: −0.44; 95% CI: −0.591, −0.297; p < 0.0001). Similar improvements with the Test strip were reported for all other evaporative (air) and tactile sensitivity endpoints (p < 0.0001 vs no-treatment) at all timepoints (10 min, 2 h, 4 h). Test strips were considered by most staff and participants slightly/moderately easy to apply (98%). Many participants rated the overall usage experience as “like moderately” (40%) or “like extremely” (20%). There were no treatment-related adverse events. Conclusion: This new CSPS-based technology may provide a novel treatment option for rapid relief from DH (Clinicaltrials.gov NCT02937623). Clinical significance: A dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) demonstrated significantly greater dentine hypersensitivity reductions following a single application compared with no treatment. Strips were well-liked by participants and generally well tolerated. A strip containing CSPS, which dissolves within 10 min, may provide rapid relief from dentine hypersensitivity.",

keywords = "Calcium sodium phosphosilicate, Clinical trial, Dentine hypersensitivity, Dissolvable strip, Occlusion",

author = "John Gallob and Ling, {Martin R.} and Pejmon Amini and Avinash Patil and Mounir Atassi",

note = "This study was funded by GSK Consumer Healthcare, Weybridge, Surrey, UK of which Martin Ling and Mounir Atassi are employees. John Gallob is an Independent Contractor to, and Pejmon Amini is an employee of, Silverstone Research Group; Avinash Patil was an employee of Syneos Health at the time of the study. Silverstone Research Group and Syneos Health have received funding from GSK Consumer Healthcare.",

year = "2019",

month = jul,

day = "12",

doi = "10.1016/j.jjodo.2019.100003",

language = "English",

volume = "91",

journal = "Journal of Dentistry",

issn = "2589-7004",

publisher = "Elsevier Ltd",

number = "Supplement",

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TY - JOUR

T1 - Efficacy of a dissolvable strip with calcium sodium phosphosilicate (NovaMin®) in providing rapid dentine hypersensitivity relief

AU - Gallob, John

AU - Ling, Martin R.

AU - Amini, Pejmon

AU - Patil, Avinash

AU - Atassi, Mounir

N1 - This study was funded by GSK Consumer Healthcare, Weybridge, Surrey, UK of which Martin Ling and Mounir Atassi are employees. John Gallob is an Independent Contractor to, and Pejmon Amini is an employee of, Silverstone Research Group; Avinash Patil was an employee of Syneos Health at the time of the study. Silverstone Research Group and Syneos Health have received funding from GSK Consumer Healthcare.

PY - 2019/7/12

Y1 - 2019/7/12

N2 - Objective: To evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin®) in providing rapid relief from dentine hypersensitivity (DH). Methods: In this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10 min, 2 h and 4 h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. Results: At 10 min post-application, mean Schiff score change from baseline (primary endpoint) was statistically significant with the Test strip (−0.46; 95% confidence intervals [CI]: −0.563, −0.356; p < 0.0001) but not with No treatment (−0.02; 95% CI: −0.119, 0.088; p = 0.7664). The between-treatment group difference favored the Test strip (difference: −0.44; 95% CI: −0.591, −0.297; p < 0.0001). Similar improvements with the Test strip were reported for all other evaporative (air) and tactile sensitivity endpoints (p < 0.0001 vs no-treatment) at all timepoints (10 min, 2 h, 4 h). Test strips were considered by most staff and participants slightly/moderately easy to apply (98%). Many participants rated the overall usage experience as “like moderately” (40%) or “like extremely” (20%). There were no treatment-related adverse events. Conclusion: This new CSPS-based technology may provide a novel treatment option for rapid relief from DH (Clinicaltrials.gov NCT02937623). Clinical significance: A dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) demonstrated significantly greater dentine hypersensitivity reductions following a single application compared with no treatment. Strips were well-liked by participants and generally well tolerated. A strip containing CSPS, which dissolves within 10 min, may provide rapid relief from dentine hypersensitivity.

AB - Objective: To evaluate the efficacy of a dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) (Novamin®) in providing rapid relief from dentine hypersensitivity (DH). Methods: In this examiner-blind, proof-of-principle study, 120 healthy adults with DH were randomized 1:1 to the Test strip, professionally applied to facial surfaces of two selected teeth, or to No treatment. Sensitivity was assessed at baseline and 10 min, 2 h and 4 h post-application in response to evaporative (air) and tactile stimuli (measured by Schiff sensitivity scale/a numeric rating scale and tactile threshold, respectively). Change from baseline was analyzed by ANCOVA. Results: At 10 min post-application, mean Schiff score change from baseline (primary endpoint) was statistically significant with the Test strip (−0.46; 95% confidence intervals [CI]: −0.563, −0.356; p < 0.0001) but not with No treatment (−0.02; 95% CI: −0.119, 0.088; p = 0.7664). The between-treatment group difference favored the Test strip (difference: −0.44; 95% CI: −0.591, −0.297; p < 0.0001). Similar improvements with the Test strip were reported for all other evaporative (air) and tactile sensitivity endpoints (p < 0.0001 vs no-treatment) at all timepoints (10 min, 2 h, 4 h). Test strips were considered by most staff and participants slightly/moderately easy to apply (98%). Many participants rated the overall usage experience as “like moderately” (40%) or “like extremely” (20%). There were no treatment-related adverse events. Conclusion: This new CSPS-based technology may provide a novel treatment option for rapid relief from DH (Clinicaltrials.gov NCT02937623). Clinical significance: A dissolvable strip containing 15% w/w calcium sodium phosphosilicate (CSPS) demonstrated significantly greater dentine hypersensitivity reductions following a single application compared with no treatment. Strips were well-liked by participants and generally well tolerated. A strip containing CSPS, which dissolves within 10 min, may provide rapid relief from dentine hypersensitivity.

KW - Calcium sodium phosphosilicate

KW - Clinical trial

KW - Dentine hypersensitivity

KW - Dissolvable strip

KW - Occlusion

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DO - 10.1016/j.jjodo.2019.100003

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VL - 91

JO - Journal of Dentistry

JF - Journal of Dentistry

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