Slezak Brian, Santarpia Peter, Xu Tao, Monsul-Barnes Virginia, Heu Rodman T, Stranick Michael, Sullivan Richard, Petrou Irene, Bagley Daniel, Li Yiming
Colgate-Palmolive Technology Center, Piscataway, New Jersey, USA.
Compend Contin Educ Dent. 2002 Nov;23(11 Suppl 1):4-11.
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.
高露洁亮白清新美白啫喱是一种非处方家用牙齿美白产品，为刷涂式液体啫喱，其活性成分含18%过氧化脲（相当于6.5%过氧化氢）。辅料包括牙膏中常用的成分。已对这种含过氧化物产品对牙髓的影响、口腔软组织刺激、牙釉质损伤和牙齿敏感的可能性进行了评估。一项体外研究表明，髓腔中的过氧化氢水平远低于被认为会对牙髓组织产生影响的水平。一项过度使用（每天4次，持续3周）的临床研究表明，使用3周期间未发生口腔刺激。一项测量使用高露洁亮白清新美白啫喱后唾液中过氧化物浓度的研究表明，使用该产品后唾液中的过氧化物浓度极低，进一步证明该产品引起口腔刺激的可能性较低。其他研究表明，高露洁亮白清新美白啫喱在相当于正常使用3周和过度使用6周的暴露后，不会损害牙釉质表面或产生脱矿。在141名使用不同治疗方案的临床受试者群体中，高露洁亮白清新美白啫喱未产生口腔刺激（软硬组织）或牙齿过敏。这些研究证明，高露洁亮白清新美白啫喱按指示每日使用是安全的。
