Williams C, McBride S, Mostler K, Petrone D M, Simone A J, Crawford R, Patel S, Petrone M E, Chaknis P, DeVizio W, Volpe A R, Proskin H M
McWill Research Laboratories, Inc. Atlanta, Georgia, USA.
Compend Contin Educ Dent. 1998;19(2 Suppl):4-15.
The objective of this 6-month, double-blind, clinical study, conducted in harmony with American Dental Association (ADA) guidelines, was to evaluate the efficacy of a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base (zinc citrate dentifrice) for the control of supragingival plaque and gingivitis, compared to a control dentifrice containing 0.76% sodium monofluorophosphate in a silica base (control dentifrice). Adult men and women from the Atlanta, Georgia, area were entered in the study and stratified into two treatment groups, which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Participants received an oral prophylaxis and were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were conducted after 3 months and again after 6 months' use of the study dentifrices. Ninety-nine participants complied with the protocol and completed the entire 6-month clinical study. At both the 3- and 6-month study examinations, the zinc citrate dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group, based on whole-mouth data. At the 6-month examination, the magnitude of these reductions met or exceeded 18% for both plaque and gingivitis (25.3% for plaque; 18.8% for gingivitis). The effect of the zinc citrate dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis, indicating a statistically significant (50.2%) reduction in severe plaque and a statistically significant (66.7%) reduction in severe gingivitis over the control dentifrice after 6 months of use. Similar findings were observed for data obtained from proximal, lingual, and posterior sites. Among the sites that indicated a tendency toward high levels of plaque or gingivitis based on the baseline scores, substantially fewer sites tended to continue to present such high levels at follow-up exams in the zinc citrate dentifrice group than in the control dentifrice group. Thus, in accordance with the 1986 guidelines published by the ADA and the 1994 revision published by the Task Force on Design and Analysis in Dental and Oral Research, the results of this study support the conclusion that a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base is clinically efficacious for the control of supragingival plaque and gingivitis.
这项为期6个月的双盲临床研究是按照美国牙科协会（ADA）的指南进行的，其目的是评估一种以二氧化硅为基质、含有2%柠檬酸锌和0.76%单氟磷酸钠的牙膏（柠檬酸锌牙膏）在控制龈上菌斑和牙龈炎方面的功效，并与一种以二氧化硅为基质、含有0.76%单氟磷酸钠的对照牙膏（对照牙膏）进行比较。来自佐治亚州亚特兰大地区的成年男性和女性参与了该研究，并被分为两个治疗组，两组在基线Quigley-Hein菌斑指数得分和基线Löe-Silness牙龈指数得分方面保持平衡。参与者接受了口腔预防治疗，并被指示每天使用指定的牙膏早晚各刷牙1分钟，使用软毛牙刷。在使用研究牙膏3个月后和6个月后分别进行龈上菌斑和牙龈炎检查。99名参与者遵守了方案并完成了整个6个月的临床研究。基于全口数据，在3个月和6个月的研究检查中，柠檬酸锌牙膏组在菌斑和牙龈炎方面的减少均具有统计学意义，与对照牙膏组相比。在6个月的检查中，菌斑和牙龈炎的减少幅度均达到或超过了18%（菌斑减少25.3%；牙龈炎减少18.8%）。柠檬酸锌牙膏对菌斑和牙龈炎更严重表现的效果最为明显，表明在使用6个月后，与对照牙膏相比，严重菌斑减少了50.2%，具有统计学意义，严重牙龈炎减少了66.7%，具有统计学意义。从近中、舌侧和后部部位获得的数据也观察到了类似的结果。在根据基线得分显示有菌斑或牙龈炎高水平倾向的部位中，柠檬酸锌牙膏组在随访检查中倾向于继续呈现如此高水平的部位明显少于对照牙膏组。因此，根据ADA在1986年发布的指南以及牙科和口腔研究设计与分析特别工作组在1994年发布的修订版，本研究结果支持以下结论：一种以二氧化硅为基质、含有2%柠檬酸锌和0.76%单氟磷酸钠的牙膏在临床上对控制龈上菌斑和牙龈炎是有效的。
