Clinical Trials Group, Bristol Dental School, University of Bristol, Lower Maudlin Street, Bristol, BS1 2LY, UK.
Cardiff University, Cardiff, CF10 3AT, UK.
J Dent. 2019 Jan;80 Suppl 1:S26-S32. doi: 10.1016/j.jdent.2018.12.002.
This study tested the efficacy of a toothpaste containing enzymes and proteins reflecting those naturally occurring in saliva which play an important role in maintaining bacterial balance to improve gingival health condition and reduce supra-gingival plaque formation over a period of 13 weeks as compared to a commercial control toothpaste.
This study was a double-blind, randomised, parallel group, 3 month home use study in healthy volunteers. Non-smokers with a mean modified gingival index (MGI) score of between 2.00-2.75 and at least 20 natural teeth, a minimum of 5 teeth in each quadrant were enrolled in the study. At screening, participants underwent a dental prophylaxis and were issued with a standard fluoride toothpaste and toothbrush to use for 4 weeks. After 4 weeks, participants demonstrating ongoing eligibility were assessed for gingival health and plaque score and randomised to either test or control toothpaste, which they used at home twice daily. After 13 weeks, gingival health and plaque were re-scored.
229 participants completed the study. There were no treatment associated adverse events. Plaque and gingival scores were significantly better in the test group as compared to the control group. Furthermore, in the test group plaque and gingival scores fell, while those in the control group rose over the 13 week period.
The test toothpaste containing enzymes and proteins demonstrated significant plaque and gingival benefit compared to the control toothpaste, and was well tolerated.
Toothbrushing with the test product derived from naturally occurring enzymes and proteins had a clinical adjunctive improvement on gingival health compared to brushing alone with a commercially available fluoride toothpaste.
本研究测试了一种含有酶和蛋白质的牙膏的功效，这些酶和蛋白质反映了唾液中天然存在的、在维持细菌平衡方面发挥重要作用的物质，以改善牙龈健康状况并减少 13 周内龈上菌斑的形成，与商业对照牙膏相比。
这是一项为期 3 个月的、在家中使用的、双盲、随机、平行组的研究，纳入了健康志愿者。非吸烟者，改良牙龈指数（MGI）评分在 2.00-2.75 之间，至少有 20 颗天然牙齿，每个象限至少有 5 颗牙齿。在筛选时，参与者接受了牙齿洁治，并发放了标准的氟化物牙膏和牙刷，让他们使用 4 周。4 周后，对参与者的牙龈健康和菌斑评分进行评估，以确定其是否符合继续入选的标准，并将其随机分配到试验牙膏或对照牙膏组，让他们在家中每天使用两次。13 周后，重新评估牙龈健康和菌斑。
229 名参与者完成了研究。无与治疗相关的不良事件。试验组的菌斑和牙龈评分明显优于对照组。此外，试验组的菌斑和牙龈评分下降，而对照组的评分则在 13 周期间上升。
含有酶和蛋白质的试验牙膏与对照牙膏相比，具有显著的菌斑和牙龈益处，且耐受性良好。
与单独使用市售含氟牙膏刷牙相比，使用源自天然酶和蛋白质的试验产品刷牙，对牙龈健康具有临床辅助改善作用。
