RESUMEN
The objective of this six-month, placebo-controlled, double-blind clinical study, conducted in harmony with American Dental Association guidelines, was to provide an assessment of the effectiveness of a new dentifrice formulation of Colgate Total Toothpaste containing a special grade of silica (Colgate Total Plus Whitening Toothpaste), vs. Colgate Total Fresh Stripe Toothpaste as a control, and a placebo dentifrice without triclosan and the copolymer, for the control of supragingival dental plaque and gingivitis. Adult male and female subjects from the state of New Jersey were entered into the study, and stratified into three treatment groups which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Subjects received an oral prophylaxis, and were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were conducted after three-months' and again after six-months' participation in the study. One-hundred ten (110) subjects complied with the protocol and completed the entire six-month clinical study. At both the three- and six-month study examinations, the Colgate Total Plus Whitening Toothpaste group and the Colgate Total Fresh Stripe Toothpaste group exhibited statistically significantly less supragingival plaque and gingivitis than did the placebo toothpaste group. At the six-month examination, the magnitude of these differences exceeded 23.0% for all four parameters measured in the Colgate Total Plus Whitening Toothpaste group (29.9% for Plaque Index, 59.2% for Plaque Severity Index, 23.2% for Gingival Index, and 75.1% for Gingivitis Severity Index). Also, at the six-month examination, the magnitude of these differences exceeded 21.0% for each of the four parameters measured in the Colgate Total Fresh Stripe Toothpaste group (27.9% for Plaque Index, 54.9% for Plaque Severity Index, 21.4% for Gingival Index and 69.2% for Gingivitis Severity Index). The results of this six-month clinical study support the conclusion that Colgate Total Plus Whitening Toothpaste and Colgate Total Fresh Stripe Toothpaste provided a statistically significant, clinically relevant level of efficacy for the control of supragingival plaque and gingivitis, in accordance with the criteria provided by current American Dental Association guidelines.
Asunto(s)
Placa Dental/prevención & control , Dentífricos/uso terapéutico , Gingivitis/prevención & control , Adulto , Análisis de Varianza , Mezclas Complejas , Índice de Placa Dental , Dentífricos/química , Método Doble Ciego , Femenino , Humanos , Masculino , Índice Periodontal , Poliestirenos , Índice de Severidad de la Enfermedad , Ácido Silícico , Dióxido de Silicio , Fluoruro de Sodio , Pastas de Dientes , Resultado del Tratamiento , TriclosánRESUMEN
The objective of this double-blind clinical study, conducted in harmony with the accepted Volpe-Manhold design for studies of dental calculus, was to compare the supragingival anticalculus efficacy of three commercially available dentifrice formulations. The test toothpastes were Colgate Total Plus Whitening Toothpaste with an added high cleaning silica base, Crest Multi-Care Advanced Cleaning Toothpaste, and Colgate Winterfresh Gel. Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into three treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after eight weeks' use of the study dentifrices. One hundred (100) subjects complied with the protocol and completed the entire study. At the eight-week examination, subjects using the Colgate Total Plus Whitening Toothpaste and subjects using the Crest Multi-Care Advanced Cleaning Toothpaste exhibited statistically significant (p < 0.05) reductions in mean Volpe-Manhold Calculus Index scores as compared to the negative control dentifrice group (Colgate Winterfresh Gel). There was no statistically significant difference in mean Volpe-Manhold Calculus Index scores between subjects using the Colgate Total Plus Whitening Toothpaste and subjects using the Crest Multi-Care Advanced Cleaning Toothpaste.