title: Safety profile of a new liquid whitening gel.
abstract: Colgate Simply White Clear Whitening Gel, an at-home tooth-whitening product purchased over the counter, contains 18% carbamide peroxide (equivalent to 6.5% hydrogen peroxide) as the active ingredient in a brush-applied liquid gel. The excipients include ingredients commonly used in dentifrices. The potential for effects on the tooth pulp, oral soft tissue irritation, enamel damage, and tooth sensitivity with this peroxide-containing product have been evaluated. An in vitro study demonstrated that pulpal chamber hydrogen peroxide levels are well below those considered to cause an effect on pulpal tissue. An exaggerated-use (4 applications per day for 3 weeks) clinical study showed that no oral irritation occurred during 3 weeks of use. A study measuring peroxide salivary concentration after use of Colgate Simply White Clear Whitening Gel showed that the concentration of peroxide in the saliva after use of the product was extremely low, further supporting the position that this product has a low potential for causing oral irritation. Additional studies demonstrate that Colgate Simply White Clear Whitening Gel does not harm the enamel surface or produce demineralization after exposure equivalent to 3 weeks of normal use and over 6 weeks of exaggerated use. Colgate Simply White Clear Whitening Gel has not produced oral irritation (hard and soft tissues) or tooth hypersensitivity in a clinical subject population of 141 individuals using varying treatment regimens. These studies prove that Colgate Simply White Clear Whitening Gel is safe for daily use as directed.
authors.affiliation: Colgate-Palmolive Technology Center, Piscataway, New Jersey, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Slezak
authors.forename: Peter
authors.initials: P
authors.lastname: Santarpia
authors.forename: Tao
authors.initials: T
authors.lastname: Xu
authors.forename: Virginia
authors.initials: V
authors.lastname: Monsul-Barnes
authors.forename: Rodman T
authors.initials: RT
authors.lastname: Heu
authors.forename: Michael
authors.initials: M
authors.lastname: Stranick
authors.forename: Richard
authors.initials: R
authors.lastname: Sullivan
authors.forename: Irene
authors.initials: I
authors.lastname: Petrou
authors.forename: Daniel
authors.initials: D
authors.lastname: Bagley
authors.forename: Yiming
authors.initials: Y
authors.lastname: Li
mesh_terms: D001641:Bicuspid; D000077463:Carbamide Peroxide; D045424:Complex Mixtures; D003257:Consumer Product Safety; D003742:Dental Devices, Home Care; D003743:Dental Enamel / Q000187:drug effects; D003782:Dental Pulp / Q000187:drug effects; D003802:Dentifrices / Q000032:analysis / Q000633:toxicity*; D003807:Dentin Sensitivity; D004311:Double-Blind Method; D004338:Drug Combinations; D004577:Electron Probe Microanalysis; D005782:Gels; D006244:Hardness / Q000187:drug effects; D006801:Humans; D018625:Microscopy, Atomic Force; D016877:Oxidants / Q000032:analysis / Q000633:toxicity*; D010545:Peroxides / Q000032:analysis / Q000633:toxicity*; D012463:Saliva / Q000737:chemistry; D014073:Tooth Bleaching; D017001:Tooth Demineralization / Q000139:chemically induced; D014508:Urea / Q000031:analogs & derivatives / Q000032:analysis / Q000633:toxicity*
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