In Situ Study to Confirm the Anticaries Potential of a Sodium Monofluorophosphate Dentifrice Containing Calcium Sodium Phosphosilicate. 2017

C R Parkinson, and M Siddiqi, and S Mason, and F Lippert, and A T Hara, and D T Zero
GSK Consumer Healthcare, Weybridge, UK.

OBJECTIVE A randomized, investigator-blind, five-treatment, crossover, non-inferiority study was conducted to investigate the effect of the addition of calcium sodium phosphosilicate (CSPS), an agent known to relieve dentin hypersensitivity, to a sodium monofluorophosphate (SMFP)-containing dentifrice on the enamel remineralization potential of fluoride (F), as assessed by percentage surface microhardness recovery (%SMHR) and enamel fluoride uptake (EFU) using a standard in situ caries model. METHODS Seventy-seven subjects wearing bilateral mandibular partial dentures holding partially demineralized bovine enamel specimens 24 hours/day brushed their teeth with their assigned randomized dentifrice containing either 1500 or 0 ppm F with 5% CSPS or 1500, 500, or 0 ppm F with 0% CSPS twice daily for 21 days. The success criterion was to observe a difference in % SMHR between dentifrices containing 1500 ppm F of six units or less in the upper bound of the two-sided 95% confidence interval (CI). RESULTS Following 21 days of treatment, the upper bound CI of the %SMHR difference between the dentifrices containing 1500 ppm F was 1.66, thus within the non-inferiority limit. No statistically significant differences for %SMHR (p = 0.2601) and EFU (p = 0.2984) were noted between these two dentifrices. CONCLUSIONS The present in situ caries study provides evidence demonstrating that the addition of the calcium-containing compound CSPS to a 1500 ppm F dentifrice does not interfere with the ability of fluoride to remineralize surface-softened enamel; i.e., CSPS neither impairs nor improves the potential cariostatic value of SMFP dentifrice.

UI MeSH Term Description Entries
D010710 Phosphates Inorganic salts of phosphoric acid. Inorganic Phosphate,Phosphates, Inorganic,Inorganic Phosphates,Orthophosphate,Phosphate,Phosphate, Inorganic
D002327 Cariostatic Agents Substances that inhibit or arrest DENTAL CARIES formation. (Boucher's Clinical Dental Terminology, 4th ed) Cariostatic Effect,Cariostatic Effects,Agent, Cariostatic,Agents, Cariostatic,Cariostatic Agent,Effect, Cariostatic,Effects, Cariostatic
D002417 Cattle Domesticated bovine animals of the genus Bos, usually kept on a farm or ranch and used for the production of meat or dairy products or for heavy labor. Beef Cow,Bos grunniens,Bos indicus,Bos indicus Cattle,Bos taurus,Cow,Cow, Domestic,Dairy Cow,Holstein Cow,Indicine Cattle,Taurine Cattle,Taurus Cattle,Yak,Zebu,Beef Cows,Bos indicus Cattles,Cattle, Bos indicus,Cattle, Indicine,Cattle, Taurine,Cattle, Taurus,Cattles, Bos indicus,Cattles, Indicine,Cattles, Taurine,Cattles, Taurus,Cow, Beef,Cow, Dairy,Cow, Holstein,Cows,Dairy Cows,Domestic Cow,Domestic Cows,Indicine Cattles,Taurine Cattles,Taurus Cattles,Yaks,Zebus
D003802 Dentifrices Any preparations used for cleansing teeth; they usually contain an abrasive, detergent, binder and flavoring agent and may exist in the form of liquid, paste or powder; may also contain medicaments and caries preventives. Polishes, Dental,Dental Polishes,Dentifrice
D003807 Dentin Sensitivity Pain associated with exposed DENTIN surfaces of the teeth. Dentin Hypersensitivity,Dentine Hypersensitivity,Dentine Sensitivity,Tooth Sensitivity,Dentin Hypersensitivities,Dentin Sensitivities,Dentine Hypersensitivities,Dentine Sensitivities,Hypersensitivities, Dentin,Hypersensitivities, Dentine,Hypersensitivity, Dentin,Hypersensitivity, Dentine,Sensitivities, Dentin,Sensitivities, Dentine,Sensitivities, Tooth,Sensitivity, Dentin,Sensitivity, Dentine,Sensitivity, Tooth,Tooth Sensitivities
D005459 Fluorides Inorganic salts of hydrofluoric acid, HF, in which the fluorine atom is in the -1 oxidation state. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) Sodium and stannous salts are commonly used in dentifrices. Fluoride
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D012964 Sodium A member of the alkali group of metals. It has the atomic symbol Na, atomic number 11, and atomic weight 23. Sodium Ion Level,Sodium-23,Ion Level, Sodium,Level, Sodium Ion,Sodium 23
D012969 Sodium Fluoride A source of inorganic fluoride which is used topically to prevent dental caries. Fluoristat,Ossin,Zymafluor,Fluoride, Sodium,Fluorides, Sodium,Fluoristats,Ossins,Sodium Fluorides,Zymafluors

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