The relative anticaries effectiveness of sodium monofluorophosphate and sodium fluoride as contained in currently available dentifrice formulations. 1993

P F DePaola, and P M Soparkar, and C Triol, and A R Volpe, and L Garcia, and J Duffy, and B Vaughan
Department of Clinical Trials, Forsyth Dental Center, Boston, Massachusetts, United States.

A 36-month double-blind clinical caries study was conducted to determine the comparative anticaries efficacy of sodium monofluorophosphate (MFP) and sodium fluoride (NaF) as incorporated in dentifrice formulations. The test dentifrices which were utilized are commercially available in the United States and all have been granted the American Dental Association Seal of Acceptance for anticaries efficacy. The study was conducted in accordance with the 1988 Guidelines of the American Dental Association Council on Dental Therapeutics. The two formulations used in the NaF versus MFP comparison were Colgate Winterfresh Gel with 0.76% sodium monofluorophosphate in a silica base and Crest Regular Flavor Toothpaste with 0.24% sodium fluoride in a silica base. A third commercially-available NaF dentifrice, Colgate Junior Toothpaste with 0.243% sodium fluoride in a silica base, was included in the study for further comparison. Schoolchildren residing in Maine, U.S.A. received a baseline caries clinical examination and then were randomly assigned to the twice-daily use of one of the three dentifrices which were purchased in the marketplace and repackaged in plain white tubes. Caries clinical examinations were subsequently conducted after 2 and 3 years' use of the dentifrices. A total of 2,222 children participated in both the 2 and 3-year caries clinical examinations. The 36-month DFS (decayed and filled surfaces) and the DFT (decayed and filled teeth) mean caries increments for the three dentifrice groups were virtually identical. The children using the MFP formulation experienced a DFS of 1.50 and a DFT of 1.08; those using the Crest NaF formulation experienced a DFS of 1.48 and a DFT of 1.07; subjects in the third group (Colgate Junior Toothpaste, 0.243% NaF) had a DFS of 1.49 and DFT of 1.06. The statistical evaluation of the data consisted of the calculation of 90% confidence bounds for the ratio of (true) mean increments, in accordance with the 1988 American Dental Association Guidelines. Expressed in the language of the Guidelines, the analyses indicated that, (1) the anticaries efficacy provided by the MFP formulation, (Colgate Winterfresh Gel with 0.76% MFP) is "as good as" that provided by the NaF formulation, (Crest Regular Flavor Toothpaste, with 0.243% NaF), and (2) the anticaries efficacy provided by the one NaF formulation (Colgate Junior Toothpaste, with 0.243% NaF) is "as good as" that provided by the other, (Crest Regular Flavor Toothpaste, with 0.243% NaF).

UI MeSH Term Description Entries
D008297 Male Males
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
D002648 Child A person 6 to 12 years of age. An individual 2 to 5 years old is CHILD, PRESCHOOL. Children
D003731 Dental Caries Localized destruction of the tooth surface initiated by decalcification of the enamel followed by enzymatic lysis of organic structures and leading to cavity formation. If left unchecked, the cavity may penetrate the enamel and dentin and reach the pulp. Caries, Dental,Carious Lesions,Dental Cavities,Dental Cavity,Dental Decay,Dental White Spots,Carious Dentin,Decay, Dental,Dental White Spot,White Spot, Dental,White Spots, Dental,Carious Dentins,Carious Lesion,Cavities, Dental,Cavity, Dental,Dentin, Carious,Dentins, Carious,Lesion, Carious,Lesions, Carious,Spot, Dental White,Spots, Dental White
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
D004245 DMF Index "Decayed, missing and filled teeth," a routinely used statistical concept in dentistry. Decayed, Missing, and Filled Teeth,DMF Indexes,DMF Indexe,DMF Indices,Index, DMF,Indexe, DMF,Indexes, DMF,Indices, DMF
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
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

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