Schiff Thomas, Proskin Howard M, Zhang Yun Po, Petrone Margaret, DeVizio William
School of Dentistry, University of the Pacific, San Francisco, CA, USA.
J Clin Dent. 2006;17(5):138-44.
The objective of this examiner-blind clinical study was to investigate the efficacy of three oral hygiene regimens for the control of gingivitis and supragingival plaque.
Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the San Francisco, California area were stratified into three treatment groups, which were balanced for plaque. The groups were then randomly assigned to one of three oral hygiene regimens: 1) twice-daily tooth brushing with Colgate Total Toothpaste, accompanied by once-daily flossing after brushing; 2) twice-daily tooth brushing with Colgate Total Toothpaste without flossing; and 3) twice-daily tooth brushing with a sodium fluoride toothpaste, accompanied by once-daily flossing after brushing. All subjects were given a complete oral prophylaxis, and dispensed their assigned treatment product(s), along with a soft-bristled adult toothbrush for home use. All dentifrice products were supplied in the original packaging to which overwrapping had been applied. Subjects were instructed to brush their teeth for one minute twice daily (morning and evening) using only the dentifrice provided, and to refrain from using anything other than their assigned oral hygiene products for the duration of the study. In addition, subjects were instructed to refrain from any routine dental treatment (except emergency) during the course of the study. There were no restrictions regarding diet or smoking habits over the course of the study. Examinations for gingivitis and supragingival plaque, and oral soft tissue assessments were repeated after three months, and again after six months of product use.
One-hundred fourteen (114) subjects complied with the protocol and completed the six-month examinations. Statistical analyses showed similar results for both whole-mouth and interproximal scoring sites after six months of product use. Although not statistically significant, subjects using Colgate Total Toothpaste accompanied by the use of dental floss had numerically lower six-month scores for gingivitis and supragingival plaque formation when compared to the scores of subjects using Colgate Total Toothpaste without the use of dental floss. Relative to the sodium fluoride toothpaste accompanied by the use of dental floss, subjects using Colgate Total Toothpaste, both with and without the use of dental floss, exhibited statistically significant reductions in gingivitis and supragingival plaque formation after six months of product use.
The results of this clinical study support the conclusion that the use of Colgate Total Toothpaste, both with and without the use of dental floss, provided statistically significant improvements over the sodium fluoride toothpaste plus flossing regimen with respect to the control of gingivitis and supragingival plaque formation. Although not statistically significant, numerically lower six-month scores for gingivitis and supragingival plaque were associated with Colgate Total Toothpaste accompanied by the use of dental floss, when compared with Colgate Total Toothpaste without the use of dental floss.
本研究者盲法临床研究的目的是调查三种口腔卫生方案对牙龈炎和龈上菌斑控制的疗效。
在对牙龈炎和龈上菌斑进行基线检查后，来自加利福尼亚州旧金山地区符合条件的成年男性和女性受试者被分层为三个治疗组，这些组在菌斑方面是均衡的。然后将这些组随机分配到三种口腔卫生方案之一：1）每天两次用高露洁全效牙膏刷牙，并在刷牙后每天一次使用牙线；2）每天两次用高露洁全效牙膏刷牙但不使用牙线；3）每天两次用含氟牙膏刷牙，并在刷牙后每天一次使用牙线。所有受试者都接受了全面的口腔预防治疗，并分发了他们分配到的治疗产品，以及一支供家庭使用的软毛成人牙刷。所有牙膏产品均以原始包装供应，并进行了外包装。受试者被指示每天早晚仅使用提供的牙膏刷牙一分钟，并在研究期间避免使用除分配的口腔卫生产品以外的任何东西。此外，受试者被指示在研究过程中避免任何常规牙科治疗（紧急情况除外）。在研究过程中，对饮食或吸烟习惯没有限制。在产品使用三个月后以及六个月后，再次对牙龈炎和龈上菌斑进行检查，并进行口腔软组织评估。
114名受试者遵守了方案并完成了六个月的检查。统计分析表明，在产品使用六个月后，全口和邻面评分部位的结果相似。尽管没有统计学意义，但与不使用牙线使用高露洁全效牙膏的受试者得分相比，使用高露洁全效牙膏并使用牙线的受试者在六个月时牙龈炎和龈上菌斑形成的得分在数值上较低。相对于使用牙线的含氟牙膏，使用高露洁全效牙膏（无论是否使用牙线）的受试者在产品使用六个月后，牙龈炎和龈上菌斑形成有统计学意义的减少。
本临床研究结果支持以下结论：就牙龈炎和龈上菌斑形成的控制而言，使用高露洁全效牙膏（无论是否使用牙线）相对于含氟牙膏加牙线方案有统计学意义的改善。尽管没有统计学意义，但与不使用牙线的高露洁全效牙膏相比，使用高露洁全效牙膏并使用牙线的受试者在六个月时牙龈炎和龈上菌斑的得分在数值上较低。
