Two-Year Caries Clinical Study of the Efficacy of Novel Dentifrices Containing 1.5% Arginine, an Insoluble Calcium Compound and 1,450 ppm Fluoride

A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate...

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Veröffentlicht in:	Caries research Jg. 47; H. 6; S. 582 - 590
Hauptverfasser:	Kraivaphan, P., Amornchat, C., Triratana, T., Mateo, L.R., Ellwood, R., Cummins, D., DeVizio, W., Zhang, Y.-P.
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	Basel, Switzerland S. Karger AG 01.01.2013
Schlagworte:	Arginine Arginine - therapeutic use Calcium Carbonate - therapeutic use Cariostatic Agents - therapeutic use Child Dental Caries - prevention & control Dental Restoration, Permanent Dentifrices - therapeutic use DMF Index Double-Blind Method Female Fluorides - therapeutic use Follow-Up Studies Humans Male Original Paper Phosphates - therapeutic use Sodium Fluoride - therapeutic use Tooth Loss - prevention & control Tooth, Deciduous - drug effects Treatment Outcome Prevention Caries Fluoride Treatment Arginine
ISSN:	0008-6568, 1421-976X, 1421-976X
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Abstract	A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone.
AbstractList	A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone.A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone. A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone. A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone. Copyright [copy 2013 S. Karger AG, Basel A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone. Copyright © 2013 S. Karger AG, Basel [PUBLICATION ABSTRACT]
Author	DeVizio, W. Amornchat, C. Cummins, D. Triratana, T. Mateo, L.R. Zhang, Y.-P. Kraivaphan, P. Ellwood, R.
Author_xml	– sequence: 1 givenname: P. surname: Kraivaphan fullname: Kraivaphan, P. – sequence: 2 givenname: C. surname: Amornchat fullname: Amornchat, C. – sequence: 3 givenname: T. surname: Triratana fullname: Triratana, T. – sequence: 4 givenname: L.R. surname: Mateo fullname: Mateo, L.R. – sequence: 5 givenname: R. surname: Ellwood fullname: Ellwood, R. – sequence: 6 givenname: D. surname: Cummins fullname: Cummins, D. – sequence: 7 givenname: W. surname: DeVizio fullname: DeVizio, W. – sequence: 8 givenname: Y.-P. surname: Zhang fullname: Zhang, Y.-P. email: yun_po_zhang@colpal.com
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/23988908$$D View this record in MEDLINE/PubMed
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Cites_doi	10.1177/0022034512449464 10.1111/j.1399-302X.2008.00477.x 10.1159/000261563 10.1177/154405910408301S06 10.1002/14651858.CD002278 10.1177/154405910408301S27 10.1002/14651858.CD007868.pub2 10.1111/j.1600-0722.1996.tb00104.x 10.1159/000321139
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Copyright	2013 S. Karger AG, Basel Copyright © 2013 S. Karger AG, Basel. Copyright (c) 2013 S. Karger AG, Basel
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References_xml	– reference: Gordan VV, Garvan CW, Ottenga ME, Schulte R, Harris PA, McEdward D, Magnusson I: Could alkali production be considered an approach for caries control? Caries Res 2010;44:547-554.2107194010.1159/000321139 – reference: Nascimento MM, Gordan VV, Garvan CW, Browngardt CM, Burne RA: Correlations of oral bacterial arginine and urea catabolism with caries experience. Oral Microbiol Immunol 2009;24:89-95.1923963410.1111/j.1399-302X.2008.00477.x – reference: American Dental Association Council on Dental Therapeutics: Report of workshop aimed at defining guidelines for caries clinical trials: superiority and equivalency claims for anticaries dentifrices. J Am Dent Assoc 1988;117:663-665.3225378 – reference: Gibbons JD: Nonparametric Methods for Quantitative Analysis, ed 3. 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Cochrane Database Syst Rev 2009;1:CD002278.1253543510.1002/14651858.CD002278 – reference: Srisilapanan P, Korwanich N, Yin W, Chuensuwonkul C, Mateo, LR, Zhang YP, Cummins D, Ellwood RP: Comparison of the efficacy of a dentifrice containing 1.5% arginine and 1,450 p.p.m. fluoride to a dentifrice containing 1,450 p.p.m. fluoride alone in the management of early coronal caries as assessed using quantitative light-induced fluorescence. J Dent 2013, accepted for publication. – reference: Ellwood RP, Gomez J, Pretty IA: Caries clinical trial methods for the assessment of oral care products in the 21st century. Adv Dent Res 2012;24:32-35.2289967610.1177/0022034512449464 – reference: United States Department of Health and Human Services: Oral health in America: a report of the Surgeon General. Washington, DC, 2000. – reference: Hu DY, Yin W, Li X, Feng Y, Zhang YP, Cummins D, Mateo LR, Ellwood RP: A clinical investigation of the efficacy of a dentifrice containing 1.5% arginine and 1,450 p.p.m. fluoride, as sodium monofluorophosphate in a calcium base, on primary root caries. J Clin Dent 2013, accepted for publication. – reference: Pitts NB, Stamm JW: International Consensus Workshop on Caries Clinical Trials (ICW-CCT) - final consensus statements: agreeing where the evidence leads. J Dent Res 2004;83(special issue C):125-128.1528613910.1177/154405910408301S27 – reference: Yin W, Hu DY, Li X, Fan X, Zhang YP, Pretty IA, Mateo LR, Cummins D, Ellwood RP: The anti-caries efficacy of a dentifrice containing 1.5% arginine and 1,450 p.p.m. fluoride as sodium monofluorophosphate assessed using quantitative light-induced fluorescence (QLF). 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SubjectTerms	Arginine Arginine - therapeutic use Calcium Carbonate - therapeutic use Cariostatic Agents - therapeutic use Child Dental Caries - prevention & control Dental Restoration, Permanent Dentifrices - therapeutic use DMF Index Double-Blind Method Female Fluorides - therapeutic use Follow-Up Studies Humans Male Original Paper Phosphates - therapeutic use Sodium Fluoride - therapeutic use Tooth Loss - prevention & control Tooth, Deciduous - drug effects Treatment Outcome
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Title	Two-Year Caries Clinical Study of the Efficacy of Novel Dentifrices Containing 1.5% Arginine, an Insoluble Calcium Compound and 1,450 ppm Fluoride
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