RESUMEN
The objective of this randomized, controlled, examiner-blind, parallel-group clinical study was to determine whether a tooth-whitening gel (Colgate Simply White Night Clear Whitening Gel) can significantly lighten teeth when used once daily at night, as compared with a commercially available dentifrice. Following a baseline tooth shade evaluation using the VITA Shade Guide, qualifying adult male and female subjects from the Buffalo, New York area were randomized into 2 treatment groups, which were balanced for baseline VITA Shade Guide scores, gender, and age. The treatment groups were: (1) a commercially available dentifrice only; and (2) a tooth-whitening gel in addition to a commercially available dentifrice. Subjects assigned to the 2 groups were given the dentifrice and a soft-bristled toothbrush. In addition, subjects in one of the groups were given the tooth-whitening gel. All subjects were instructed to brush their teeth for 1 minute twice daily (morning and evening) with the dentifrice. The subjects in the group also using the tooth-whitening gel were further instructed to apply the gel once daily at night, as per manufacturer instructions. Evaluations of tooth shade for each subject were repeated after 2 weeks, and again after 3 weeks of product use. In addition, evaluations of tooth shade for subjects using the tooth-whitening gel were later conducted at 6 months after product use. Seventy-five subjects complied with the protocol and completed the study. At the 2-week and 3-week examinations, subjects using the tooth-whitening gel and dentifrice exhibited statistically significant (P < .05) tooth shade lightening relative to baseline tooth shade. Furthermore, at the 2-week and 3-week examinations, subjects using the tooth-whitening gel exhibited statistically significant (P < .05) tooth shade lightening relative to subjects using only the dentifrice. In addition, the 6-month-postuse examination showed that subjects using the tooth-whitening gel exhibited statistically significant (P < .05) tooth shade lightening relative to baseline, thereby maintaining the tooth shade lightening that was evident at 3 weeks. The results of this clinical study indicate that after once-daily use at night for 2 or 3 weeks, the tooth-whitening gel provided statistically significant tooth shade lightening relative to baseline tooth shade for up to at least 6 months and also provided statistically significant tooth shade lightening relative to a commercially available dentifrice after 2 and 3 weeks of product use.
Asunto(s)
Dentífricos/uso terapéutico , Blanqueamiento de Dientes/métodos , Urea/análogos & derivados , Adolescente , Adulto , Anciano , Análisis de Varianza , Peróxido de Carbamida , Color , Mezclas Complejas , Combinación de Medicamentos , Femenino , Estudios de Seguimiento , Geles , Humanos , Masculino , Persona de Mediana Edad , Oxidantes/administración & dosificación , Oxidantes/uso terapéutico , Peróxidos/administración & dosificación , Peróxidos/uso terapéutico , Método Simple Ciego , Diente/patología , Cepillado Dental/instrumentación , Urea/administración & dosificación , Urea/uso terapéuticoRESUMEN
The objective of this double-blind clinical study was to investigate the tooth whitening efficacy of a formulation variant of a commercially available dentifrice (Colgate Total Plus Whitening Toothpaste) obtained by the addition of high cleaning silica, relative to that of its currently marketed formulation (Colgate Total Toothpaste). Following a baseline examination, qualifying adult male and female subjects were randomized into two treatment groups which were balanced for age, gender and level of extrinsic tooth stain. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. After one, and again after two weeks' use of the assigned dentifrices, a randomly selected panel of subjects was examined for soft tissue findings. Examinations for extrinsic tooth stain were repeated for all subjects after six weeks' use of the study dentifrices. Ninety-seven (97) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the new dentifrice formulation group exhibited statistically significantly (p < 0.05) lower levels of extrinsic tooth stain area and extrinsic tooth stain intensity than did those subjects assigned to the Colgate Total Toothpaste group. Thus, the results of this double-blind clinical study support the conclusion that the new dentifrice formulation variant is efficacious for the removal of extrinsic tooth stain.