Y.P. ZHANG’s research while affiliated with Colgate-Palmolive and other places

Purpose: To investigate the clinical efficacy in controlling established gingivitis and dental plaque of a 1450 ppm fluoride as sodium monofluorophosphate (SMFP)/zinc-based dentifrice, as compared to a zinc-free dentifrice with 1450 ppm fluoride as SMFP after six months product use. Methods: A six-month clinical study, with eighty-six (86) subjects, was conducted in Chengdu, China, using a double-blind, randomized, parallel-group treatment design. After a baseline evaluation, study subjects were randomly assigned to one of the two study treatments: 1) 1450 ppm fluoride as SMFP/zinc-based dentifrice (Test) or 2) 1450 ppm fluoride as SMFP/zinc-free dentifrice (Negative Control). Subjects were provided with a soft bristle toothbrush and brushed their teeth twice daily (morning and evening) for one minute with their assigned dentifrice. After three months, and again after six months of product use, subjects returned to the testing facility for their follow- up gingivitis and plaque examinations. Statistical analyses were performed separately for the gingivitis assessments and dental plaque assessments using the appropriate statistical methods. All statistical tests of hypotheses were two-sided, and employed a level of significance of a = 0.05. Results: After three and six months of product use, subjects assigned to the Test treatment exhibited statistically significant (p < 0.001) reductions in gingival index and plaque index scores as compared to subjects assigned to the Negative Control treatment. Conclusion: The results of this single-center, double-blind, parallel-group and randomized clinical study support the conclusion that a 1450 ppm fluoride as SMFP/zinc-based dentifrice provides clinically meaningful and statistically significant reductions in gingivitis (23.8%) and dental plaque (22.5%) as compared to a 1450 ppm fluoride as SMFP/zinc-free dentifrice over a six-month period of twice- daily product use.

Objective: To assess the tooth whitening efficacy of a whitening toothpaste containing 0.1% Hydrogen Peroxide and 1450 ppm fluoride as MFP (Test) as compared to a non-whitening toothpaste containing 1000 ppm MFP (Negative Control) after 8-weeks of use. Method: This study was a two-cell, double-blind, parallel-group and double-blind clinical study. Following a baseline examination of tooth color shade, qualifying subjects were randomized into two treatment groups which were balanced for Vita Classic Shade Guide scores. Subjects were instructed to brush twice daily (morning and evening) for one minute with their assigned toothpaste, using a soft-bristled toothbrush, for 8-weeks. Result: Eighty-one subjects that entered the study completed the 8-week study. After 4-weeks, subjects in the Test group and the Negative Control group both exhibited statistically significant (p<0.05) mean tooth shade guide improvements of (1.86 units and 0.22 units respectively) as compared to baseline. Subjects in the Test group exhibited a statistically significant (p<0.05) whitening improvement of 1.64 units in mean tooth shade as compared to subjects in the Negative Control group. After 8-weeks subjects in the Test group and Negative Control group both exhibited statistically significant (p<0.05) mean tooth shade guide improvements of (2.27 units and 0.38 units respectively) as compared to baseline. Subjects in the Test group exhibited a statistically significant (p<0.05) whitening improvement of 1.89 units in mean tooth shade as compared to subjects in the Negative Control group. Conclusion: A whitening toothpaste containing 0.1% hydrogen peroxide and 1450 ppm MFP exhibited statistically significant improvements in tooth whitening, measured using the Vita Classic Shade Guide as compared to baseline and to a non-whitening toothpaste as a negative control after 4-weeks and 8-weeks of use.

Objective: The objective of this three-cell, double-blind, randomized clinical study conducted in San Luis Potosi, Mexico was to evaluate the dentin hypersensitivity reduction efficacy of three commercially-available toothpastes immediately after a supervised, one-time product use: (1) 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (SMFP) [Colgate® Sensitive Pro-Relief™ Toothpaste] (arginine toothpaste), (2) 0.6% stannous chloride, zinc citrate and 1450 ppm fluoride, as sodium fluoride [Oral-B® Pro-Salud/Crest® ProHealth Clinical Protection Sensitive] (stannous toothpaste), (3) 1450 ppm fluoride, as SMFP [Colgate® Cavity Protection Toothpaste] (fluoride control). Method: One-hundred-and-fifty adults with confirmed dentin hypersensitivity were assigned to supervised use of one of the three dentifrices. The use of the arginine toothpaste consisted of a single direct topical application of the toothpaste directly onto the gingivo-facial 1/3 of each of the two study teeth using a fingertip, followed by gently massaging each tooth for sixty seconds. The use of the stannous toothpaste and the fluoride control toothpaste consisted of brushing the two study teeth for 30 seconds each before brushing the remaining teeth for one minute. Result: Relative to the stannous toothpaste group, subjects in the arginine toothpaste group exhibited statistically significant (P<0.05) improvements in tactile (68.3%) and in air blast hypersensitivity (49.0%) immediately after product use. Relative to the fluoride control, subjects that brushed with the stannous toothpaste, did not exhibit statistically significant tactile or air blast hypersensitivity improvements (8.3% and 2.8% respectively). Conclusion:The results of this clinical study demonstrated instant relief of dentin hypersensitivity as a result of a single direct topical application of the toothpaste containing 8% arginine/calcium carbonate compared to a single brushing with the toothpaste containing 0.6% stannous chloride/zinc citrate. In contrast, a single brushing with the 0.6% stannous chloride/zinc citrate toothpaste did not reduce dentin hypersensitivity compared to brushing with the fluoride control toothpaste.

Objective: The aim of this two-cell, double-blind clinical study was to assess the intrinsic tooth whitening efficacy for (1) Colgate Optic White Toothpaste (1% H2O2 and 0.76% sodium monofluorophosphate), and (2) matching placebo (0% H2O2and 0.76% sodium monofluorophosphate). Method: Baseline Mean shade guide scores (Vitapan Classical) among maxillary anterior teeth were calculated for each of the consenting participants 7 days after a professional dental prophylaxis procedure. Participants were then randomly assigned to brush twice daily (morning and evening) for 1 minute each time with either the test or placebo dentifrice. Mean tooth shade guide and soft tissue examinations were repeated after 1 and 4 weeks of assigned product use. All examinations were performed under the same lighting condition and by the same examiner. Result: Eighty voluntary participants entered the study, complied with the protocol and completed the four week clinical trial. Both study groups (test and placebo) were balanced for Vita shade guide scores and all participants had an A3 or darker mean shade score at the baseline examination. The mean tooth shade improvements after 1 and 4 weeks of product use were respectively 1.05 and 2.38 for the test group and, 0.09 and 0.23, for the placebo group. The test group demonstrated statistically significant (p<0.05) whitening improvements of 0.96 in mean tooth shade as compared to the placebo group after 1 week of product use and 2.15 after 4 weeks of product use. Conclusion: The clinical results demonstrate that the 1% H2O2 and 0.76% sodium monofluorophosphate dentifrice provides statistically significant intrinsic tooth whitening improvements in mean shade scores as compared to a matching placebo dentifrice after 1 and 4 weeks use.

Objetivo: Comparar la eficacia para detener y revertir las lesiones de caries coronal en estadio temprano en niños, de un nuevo dentífrico que contiene arginina al 1.5%, un compuesto de calcio insoluble y 1450 ppm de fluoruro con un dentífrico control positivo con 1450 ppm de fluoruro, mediante el uso de Fluorescencia Cuantitativa Inducida por Luz (QLF). Diseño del Estudio: 331 niños de Chiang Mai, Tailandia, de 7 a 14 años de edad, con una o más lesiones visibles de caries en esmalte en estadio temprano en los dientes anteriores superiores, completaron el estudio. El nuevo dentífrico contenía arginina al 1.5%, un compuesto de calcio insoluble y 1450 ppm de fluoruro como monofluorofosfato de sodio; el control positivo tenía sólo 1450 ppm de fluoruro. Los sujetos se cepillaron dos veces al día en casa y una vez adicional en días escolares bajo la supervisión de un profesor. Se tomaron imágenes digitales de los seis dientes anteriores superiores al inicio, a los 3 y a los 6 meses usando un aparato hecho a la medida para lograr la obtención reproducible de los datos de Fluorescencia Cuantitativa Inducida por Luz. Resultados: En el examen de los 3 meses, el ΔQ (que representa el volumen de la lesión) para el grupo de estudio, disminuyó de una media de 28.62 al inicio hasta 20.53 mm2% y en el grupo control positivo hasta 23.38 mm2%. La diferencia entre los grupos no fue estadísticamente significativa (p=0.055). En el examen de los 6 meses, el ΔQ disminuyó en el grupo de estudio a 15.85 mm2% y en el grupo control positivo a 20.35 mm2%. La diferencia entre los grupos fue estadísticamente significativa (p<0.001). Conclusión: Un nuevo dentífrico que contiene arginina al 1.5%, un compuesto de calcio insoluble y 1450 ppm de fluoruro como monofluorofosfato de sodio, tuvo una eficacia significativamente superior desde el punto de vista estadístico para detener y revertir las lesiones coronales activas de caries en niños que el cepillado con un dentífrico control positivo que contiene fluoruro solamente.

Objetivo Evaluar la capacidad de un nuevo dentífrico con arginina al 1.5% y 1450 ppm de fluoruro para detener y revertir las lesiones naturales de caries vestibular en niños. Diseño del estudio Participantes de Chengdu, en la Provincia de Sichuan en China, probaron tres dentífricos: un nuevo dentífrico con arginina al 1.5%, un compuesto de calcio insoluble y 1450 ppm de fluoruro, como monofluorofosfato de sodio; un dentífrico control positivo con 1450 ppm de fluoruro como fluoruro de sodio en una base de sílica; y un dentífrico control negativo sin arginina y sin fluoruro. La Fluorescencia Cuantitativa Inducida por Luz (QLF) se utilizó para evaluar las lesiones de caries vestibular al inicio, y después de 3 y 6 meses de uso del producto. Resultados 438 participantes (edad inicial 9-13 años [media 11.1 ± 0.78] y 48.6% de sexo femenino) completaron el estudio. Durante la duración del estudio, no se reportaron efectos adversos que pudieran atribuirse a los productos. La media de ΔQ de los sujetos (%mm2) que representa el volumen de la lesión fue de 27.26 al inicio. Después de 6 meses de uso del producto, los valores ΔQ fueron 13.46, 17.99 y 23.70 para el dentífrico con arginina, el control positivo y el control negativo respectivamente, lo que representó una mejoría desde el inicio de 50.6%, 34.0% y 13.1%. Después de 6 meses de uso del producto, las diferencias entre las comparaciones por pares de los tres grupos fueron estadísticamente significativas (p<0.01). Después de sólo 3 meses, el dentífrico que contiene arginina mostró una mejoría que fue casi idéntica a la lograda con el dentífrico convencional con 1450 ppm de fluoruro después de 6 meses. Conclusión el nuevo dentífrico que contiene arginina al 1.5%, un compuesto de calcio insoluble y 1450 ppm de fluoruro, proporciona una eficacia superior desde el punto de vista estadístico para detener y revertir las lesiones de caries vestibular que un dentífrico convencional que contiene 1450 ppm de fluoruro solamente.

The purpose of this study was to assess the ability of a new dentifrice containing arginine, an insoluble calcium compound, and fluoride to arrest or reverse naturally occurring buccal caries lesions measured using Quantitative Light-induced Fluorescence (QLF). Three study groups used dentifrices which contained 1) 1.5% arginine and 1450 ppm fluoride as sodium monofluorophosphate (experimental), 2) 1450 ppm fluoride as sodium monofluorophosphate (positive control), and 3) no fluoride (negative control). All three dentifrices were formulated in the same calcium base. The study participants were from three schools in the city of Chengdu, Sichuan Province, China. A total of 446 of 450 recruited subjects completed the study. Of these, 147 were in the experimental, 148 in the positive control, and 151 in the negative control groups. The initial age of the children was 10-12 years (mean 11.4 +/- 0.54); 47.5% were female. Using QLF, assessments of buccal caries lesions were made at baseline and after three and six months of product use. For AQ, representing lesion volume, the baseline mean value for the three groups was 27.30, and at the three-month examination the mean values were 16.76, 19.25, and 25.89 for the experimental, positive, and negative control dentifrices, respectively. This represents improvements from baseline of 38.6%, 29.5%, and 5.2%. At six months, the deltaQ values for the three groups were 13.46, 18.47, and 24.18, representing improvements from baseline of 50.7%, 32.3%, and 11.4%. For all QLF metrics, deltaF (loss of fluorescence), area, and deltaQ, the differences between the negative control and both the experimental and positive control groups were statistically significant (p < or = 0.01). The differences between the experimental and positive control groups attained statistical significance for deltaQ (p < or = 0.003) at the six-month examination. It is concluded that both of the fluoride-containing toothpastes are significantly better at arresting and reversing buccal caries lesions than the non-fluoride toothpaste. Furthermore, it is concluded that the new dentifrice containing arginine, an insoluble calcium compound, and fluoride provides significantly greater anticaries benefit than a dentifrice containing fluoride alone.

The purpose of this six-month study was to assess the ability of a new dentifrice containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride, as sodium monofluorophosphate, to arrest and reverse primary root caries lesions in adults. Three test groups used dentifrices which contained either: 1) 1.5% arginine and 1450 ppm fluoride as sodium monofluorophosphate in a calcium base (experimental); 2) 1450 ppm fluoride as sodium fluoride in a silica base (positive control); or 3) no fluoride in a calcium base (negative control). The study participants were residents of the city of Chengdu, Sichuan Province, China. In order to take part, subjects had to have at least one non-cavitated primary root caries lesion. A total of 412 subjects completed the study. They were aged from 50 to 70 years (mean age 64 +/- 4.1 years) and 53.6% were female. Efficacy for arresting and reversal of primary root caries was assessed by clinical hardness measures and through the use of the Electrical Caries Monitor. After three months of product use, clinical hardness measures showed that 27.7%, 24.6%, and 13.1% of lesions had improved in the experimental, positive, and negative control groups, respectively, and 0.7%, 4.5%, and 16.8% had become worse, respectively. The differences in the distribution of lesion change between the negative control group and both the experimental (p < 0.001) and positive control (p = 0.001) were statistically significant. The Electrical Caries Monitor was also used as an objective measure of lesion severity. The end values increased from baseline to the three-month examinations, but none of the differences between the groups attained statistical significance. After six months, clinical hardness measures showed that only one lesion (0.7%) was worse than at the baseline examination-in the experimental group compared to 9.0% and 18.2% in the positive and negative control groups, respectively. In addition, 61.7%, 56.0%, and 27.0%, respectively, showed improvement for the three groups. The differences in the distribution of lesion change scores between the negative control group and both the experimental (p < 0.001) and positive control (p < 0.001) were statistically significant, as was the difference between the experimental group and the positive control (p = 0.006). The Electrical Caries Monitor end values for the experimental, positive, and negative control groups at the six-month examination were 7.9, 1.9 mega omega(s), and 387 kilo omegas(s), respectively. The differences between the negative control group and both the experimental (p < 0.001) and positive control (p < 0.001) were statistically significant. The difference between the experimental and positive control groups was also statistically significant (p = 0.03). It is concluded that the new toothpaste containing 1.5% arginine and 1450 ppm fluoride, as sodium monofluorophosphate in a calcium base, provided greater anticaries benefits than a conventional toothpaste containing 1450 ppm fluoride. Both fluoride toothpastes demonstrated greater benefits than non-fluoride toothpaste.

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.