Barnes Caren M, Russell Carl M, Reinhardt Richard A, Payne Jeffrey B, Lyle Deborah M
UNMC College of Dentistry, Lincoln, NE, USA.
J Clin Dent. 2005;16(3):71-7.
The purpose of this twenty-eight day, randomized, single-blind clinical trial was to assess the efficacy of the addition of daily oral irrigation to both power and manual tooth brushing, compared to a traditional regimen of manual tooth brushing and flossing, to determine which regimen had the greatest effect on the reduction of gingival bleeding, gingivitis, and supragingival plaque.
The study was designed for a total of 105 subjects to participate in a twenty-eight day trial, with 35 subjects randomly assigned to one of three groups: Group 1-manual toothbrush and floss; Group 2-manual toothbrush and dental water jet; and Group 3-sonic toothbrush and dental water jet. All subjects received written and verbal instructions for using their regimens. Subjects were asked to brush for a timed two minutes, twice per day, with the brush and the dentifrice provided, and to refrain from using any additional oral hygiene aids. Subjects using the dental water jet were instructed to use the water jet on a medium setting, irrigating once per day with 500 ml of luke warm water. Subjects using the dental floss were instructed to use the floss once daily. Subjects were examined by two calibrated examiners, and data were collected at baseline (BSL), 14 days (D14), and 28 days (D28). Subjects were asked to abstain from any oral hygiene for 12 hours prior to each study visit. Subjects were scored using the Carter and Barnes Bleeding Index, Löe and Silness Gingival Index, and the Proximal/Marginal Plaque Index. Mean scores on the three indices for the three groups were used for statistical analysis at each time point. Additionally, the means were used for comparisons as change from baseline and percent change from baseline at D14 and D28. The significance of percentage change in each index from baseline to D14 and D28 was evaluated using a one-tailed t-test. Significant differences are reported at alpha < or = 0.05 for these planned group comparisons.
Thirty-one subjects in Group 1, 32 subjects in Group 2, and 32 subjects in Group 3 completed the study. Bleeding Index: Groups 2 and 3, the irrigation groups, were statistically significantly more effective than Group 1 in reducing the bleeding index at D14 and D28, whether measured by mean reduction or percentage reduction. Gingival Index: At D14, both irrigation groups demonstrated a statistically significantly greater reduction in the gingival index compared to brushing and flossing for the facial surfaces. There was no significant difference between groups for the lingual surface at D14. At D28 there was a significant difference between Groups 1 and 2 for both the facial and lingual surfaces. Plaque Index: There was one significant difference between groups for the plaque index measured on the lingual surfaces. The manual toothbrush and floss were less effective than the sonic toothbrush and irrigation. Group 3 was also significantly better than Group 1 in reducing the plaque index on the facial surfaces at both D14 and D28. On plaque percentage reduction on the facial surface, Group 2 was significantly better than Group 1 at D14. There was no statistical difference between Group 1 and Group 2 at D28.
The results of this clinical trial indicate that when combined with manual or sonic tooth brushing, oral irrigation is an effective alternative to manual tooth brushing and dental floss for reducing bleeding, gingival inflammation, and plaque removal.
这项为期28天的随机单盲临床试验旨在评估与传统的手动刷牙和使用牙线方法相比,每日在电动牙刷和手动刷牙基础上增加口腔冲洗的效果,以确定哪种方法对减少牙龈出血、牙龈炎和龈上菌斑效果最佳。
该研究设计招募105名受试者参与为期28天的试验,35名受试者被随机分配到三组中的一组:第1组——手动牙刷和牙线;第2组——手动牙刷和口腔冲洗器;第3组——声波牙刷和口腔冲洗器。所有受试者均收到关于其使用方法的书面和口头说明。要求受试者每天用提供的牙刷和牙膏定时刷牙两分钟,每天两次,且不得使用任何其他口腔卫生辅助工具。使用口腔冲洗器的受试者被指导使用中等强度设置,每天用500毫升温水冲洗一次。使用牙线的受试者被指导每天使用一次牙线。由两名经过校准的检查人员对受试者进行检查,并在基线(BSL)、第14天(D14)和第28天(D28)收集数据。每次研究访视前,要求受试者12小时内不进行任何口腔卫生清洁。使用卡特和巴恩斯出血指数、洛和西勒尼斯牙龈指数以及邻面/边缘菌斑指数对受试者进行评分。三组在三个指数上的平均得分用于每个时间点的统计分析。此外,这些平均值用于比较与基线的变化以及在D14和D28时相对于基线的百分比变化。使用单尾t检验评估每个指数从基线到D14和D28的百分比变化的显著性。对于这些计划好的组间比较,当α≤0.05时报告显著差异。
第1组31名受试者、第2组32名受试者和第3组32名受试者完成了研究。出血指数:第2组和第3组(冲洗组)在D14和D28时,无论是通过平均降低值还是降低百分比来衡量,在降低出血指数方面在统计学上均显著优于第1组。牙龈指数:在D14时,两个冲洗组在面部表面的牙龈指数降低方面与刷牙和使用牙线相比在统计学上均显著更大。在D14时,舌面组间无显著差异。在D28时,第1组和第2组在面部和舌面均存在显著差异。菌斑指数:在舌面测量的菌斑指数组间存在一个显著差异。手动牙刷和牙线在减少菌斑方面不如声波牙刷和冲洗有效。第3组在D14和D28时在减少面部表面菌斑指数方面也显著优于第1组。在面部表面菌斑减少百分比方面,第2组在D14时显著优于第1组。在D28时,第1组和第2组之间无统计学差异。
这项临床试验的结果表明,与手动或声波刷牙相结合时,口腔冲洗是替代手动刷牙和使用牙线减少出血、牙龈炎症和去除菌斑的有效方法。