Section of Graduate Periodontology, Faculty of Odontology, University Complutense, Madrid, Spain.
Etiology and Therapy of Periodontal Diseases (ETEP) Research Group, Faculty of Odontology, University Complutense, Madrid, Spain.
Int J Dent Hyg. 2017 Nov;15(4):269-279. doi: 10.1111/idh.12254. Epub 2016 Oct 20.
To compare the effect of two newly formulated chlorhexidine (CHX) and cetylpyridinium chloride (CPC) mouthrinses after scaling and root planing (SRP) in terms of clinical, microbiological, patient-based variables and adverse events, with a positive control with the same active components, already marketed and tested.
A pilot, randomized clinical trial, double-blind, parallel design with 1-month follow-up was conducted. Chronic periodontitis patients requiring non-surgical periodontal therapy were enrolled and randomly assigned to: (i) SRP and test-1 (new reformulation: 0.12% CHX and 0.05% CPC); (ii) SRP and test-2 (new formulation: 0.03% CHX and 0.05% CPC); or (iii) SRP and positive control (commercial product: 0.12% CHX and 0.05% CPC). All variables were evaluated at baseline and 1 month after SRP. Quantitative variables were compared by means of anova or Kruskal-Wallis test and qualitative variables by chi-square or McNemar tests.
Thirty patients (10 per group) were included. After 1 month, there were significant differences among groups in plaque levels (P = 0.016) as test-1 showed less sites with plaque than test-2 (31.15% [standard error-SE 2.21%] versus 49.39% [SE 4.60%), respectively). No significant differences were found for global patient perception of the product or in adverse effects. Test groups showed better results in levels and proportions (P = 0.022) of Capnocytophaga spp.
Within the limitations of this pilot study, it can be concluded that the newly formulated 0.12% CHX and 0.05% CPC mouthrinse showed larger plaque level reductions, without showing more adverse effects, when compared to the other two mouthrinses, after SRP.
在接受牙周刮治和根面平整术（SRP）后，比较两种新配方的洗必泰（CHX）和氯化十六烷基吡啶（CPC）漱口液在临床、微生物学、基于患者的变量和不良事件方面的效果，与具有相同活性成分的阳性对照进行比较，该阳性对照已经上市并经过测试。
进行了一项试点、随机、临床试验，采用双盲、平行设计，随访 1 个月。纳入需要非手术牙周治疗的慢性牙周炎患者，并随机分配到以下三组：（i）SRP 和测试 1（新配方：0.12%CHX 和 0.05%CPC）；（ii）SRP 和测试 2（新配方：0.03%CHX 和 0.05%CPC）；或（iii）SRP 和阳性对照（市售产品：0.12%CHX 和 0.05%CPC）。所有变量均在 SRP 前和 1 个月后进行评估。定量变量采用方差分析或 Kruskal-Wallis 检验进行比较，定性变量采用卡方检验或 McNemar 检验进行比较。
共纳入 30 名患者（每组 10 名）。1 个月后，三组间菌斑水平有显著差异（P = 0.016），测试 1 组的菌斑少于测试 2 组（分别为 31.15%[标准误差-SE 2.21%]和 49.39%[SE 4.60%]）。患者对产品的整体感知或不良事件无显著差异。测试组的 Capnocytophaga spp. 水平和比例（P = 0.022）改善更好。
在本试点研究的限制范围内，可以得出结论，与其他两种漱口液相比，新配方的 0.12%CHX 和 0.05%CPC 漱口液在接受 SRP 后，显示出更大的菌斑水平降低，且没有显示出更多的不良反应。
