Starke Michelle, Delaurenti Marcia, Ward Marilyn, Souza Sonia, Milleman Kimberly R, Milleman Jeffery L
Philips Healthcare, Bothell, WA, USA.
Salus Research, Ft. Wayne, IN, USA.
J Clin Dent. 2017 Mar;28(1 Spec No A):A29-35.
To compare the effect of the Philips Sonicare DiamondClean plus Premium plaque control brush head with the Oral-B 7000 plus CrossAction brush head on gingivitis and supragingival plaque reduction following a 42-day period of home use.
This was a randomized, parallel, examiner-blind, prospective clinical trial conducted on generally healthy subjects. Eligible subjects met the following eligibility criteria: age 18-65, non-smoker, routine manual toothbrush user, ≥ 50 sites of gingival bleeding per the Gingival Bleeding Index (GBI), and ≥ 1.8 plaque score per the Modified Plaque Index (MPI), assessed three to six hours following the last oral hygiene procedure. Eligible subjects were enrolled in the study and randomly assigned to use either a Philips Sonicare DiamondClean with Premium plaque control brush head power toothbrush (SPC) or an Oral-B® 7000 with CrossAction™ brush head power toothbrush (OCA), for twice daily home use over a period of 42 days. All subjects were dispensed a standard fluoride-containing dentifrice and both toothbrushes were to be used in their respective Deep Clean modes. Safety and efficacy evaluations were performed at 14 and 42 days following Baseline.
Two-hundred eighty-four subjects completed this trial (142 subjects per treatment group). Least squares mean (95% CI) estimates for reduction and percent reduction of gingivitis per Modified Gingival Index (MGI) following 42 days of product use for the SPC group were 1.17 (1.10, 1.24) and 45.68% (42.95%, 48.40%); for the OCA group they were 0.69 (0.62, 0.76) and 26.83% (24.10%, 29.56%). The mean difference (95% CI) between the two treatment groups was 0.48 (0.38, 0.58) and 18.85% (14.99%, 22.70%) for reduction and percent reduction, respectively. The lower limit of the 95% CI for the difference in Overall score between the two treatment groups was greater than the predefined non-inferiority margin (i.e., -0.10 or -5%); therefore SPC was declared non-inferior to OCA. In addition, since the 95% CI for the difference did not include zero, SPC was declared superior to OCA in the reduction of gingivitis per MGI at Day 42 (p-value < 0.0001). Similarly, for MGI at Day 14 and for GBI and MPI at Day 14 and Day 42, significantly larger reductions were observed for SPC compared to OCA (p-value < 0.0001).
Philips Sonicare DiamondClean with Premium plaque control brush head (SPC) was statistically superior to the Oral-B 7000 with CrossAction brush head (OCA) in reducing gingival inflammation, gingival bleeding, and supragingival plaque following 14 and 42 days of home use. Both products were safe for use.
比较飞利浦钻石亮白型进阶款专业护龈刷头电动牙刷与欧乐B 7000十字型刷头电动牙刷在居家使用42天后对牙龈炎和龈上菌斑减少的效果。
这是一项针对一般健康受试者进行的随机、平行、检查者盲法、前瞻性临床试验。符合条件的受试者需满足以下标准：年龄18 - 65岁，非吸烟者，日常使用手动牙刷，根据牙龈出血指数（GBI）牙龈出血部位≥50处，且在最后一次口腔卫生操作三至六小时后，根据改良菌斑指数（MPI）菌斑评分≥1.8。符合条件的受试者被纳入研究，并随机分配使用配备进阶款专业护龈刷头的飞利浦钻石亮白型电动牙刷（SPC）或配备十字型刷头的欧乐B® 7000电动牙刷（OCA），在家中每天使用两次，为期42天。所有受试者均获配标准含氟牙膏，且两款牙刷均需在各自的深度清洁模式下使用。在基线后的第14天和第42天进行安全性和有效性评估。
284名受试者完成了该试验（每个治疗组142名受试者）。SPC组在产品使用42天后，根据改良牙龈指数（MGI），牙龈炎减少量及减少百分比的最小二乘均值（95%置信区间）估计值分别为1.17（1.10，1.24）和45.68%（42.95%，48.40%）；OCA组分别为0.69（0.62，0.76）和26.83%（24.10%，29.56%）。两个治疗组在减少量及减少百分比方面的平均差值（95%置信区间）分别为0.48（0.38，0.58）和18.85%（14.99%，22.70%）。两个治疗组总体评分差值的95%置信区间下限大于预先定义的非劣效界值（即 -0.10或 -5%）；因此，SPC被判定不劣于OCA。此外，由于差值的95%置信区间不包括零，SPC在第42天根据MGI减少牙龈炎方面被判定优于OCA（p值<0.0001）。同样，在第14天的MGI以及第14天和第42天的GBI和MPI方面，与OCA相比，SPC观察到的减少量显著更大（p值<0.0001）。
在家中使用14天和42天后，配备进阶款专业护龈刷头的飞利浦钻石亮白型电动牙刷（SPC）在减轻牙龈炎症、牙龈出血和龈上菌斑方面在统计学上优于配备十字型刷头的欧乐B 7000（OCA）。两款产品使用均安全。
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