title: A clinical investigation of the efficacy of a tooth-whitening gel.
abstract: 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.
authors.affiliation: C.F.S. Testing, Inc., Cheektowaga, New York, USA.
authors.forename: Chester
authors.initials: C
authors.lastname: Sielski
authors.forename: Nicholas
authors.initials: N
authors.lastname: Conforti
authors.forename: Bernal
authors.initials: B
authors.lastname: Stewart
authors.forename: Pat
authors.initials: P
authors.lastname: Chaknis
authors.forename: Margaret E
authors.initials: ME
authors.lastname: Petrone
authors.forename: William
authors.initials: W
authors.lastname: DeVizio
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Volpe
authors.forename: Howard M
authors.initials: HM
authors.lastname: Proskin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000077463:Carbamide Peroxide; D003116:Color; D045424:Complex Mixtures; D003802:Dentifrices / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D016877:Oxidants / Q000008:administration & dosage / Q000627:therapeutic use; D010545:Peroxides / Q000008:administration & dosage / Q000627:therapeutic use; D016037:Single-Blind Method; D014070:Tooth / Q000473:pathology; D014073:Tooth Bleaching / Q000379:methods*; D014099:Toothbrushing / Q000295:instrumentation; D014508:Urea / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: C475021:Colgate Simply White Clear Whitening Gel; D045424:Complex Mixtures; D003802:Dentifrices; D004338:Drug Combinations; D005782:Gels; D016877:Oxidants; D010545:Peroxides; D000077463:Carbamide Peroxide; D014508:Urea