目的:该研究旨在研究过氧化氢(H2O2)和透明质酸(HA)组合制剂在第三磨牙手术后的窝愈合中的潜在有益作用。生物材料,包括漱口水配方,被假设有助于改善窝愈合和减少术后并发症。
方法:在米兰一家单中心牙科医院进行了一项三盲平行随机对照临床试验,意大利。该试验包括114名患者,他们接受了受影响的拔除,部分爆发,第三磨牙完全爆发了.患者被随机分配到三个平行组:第1组(H2O2和HA),第2组(安慰剂),和第3组(0.2%氯己定)。该试验在ClinicalTrial.gov注册(注册号NCT04438434)。主要结果测量包括与插座愈合相关的各种参数,如疼痛,炎症,肿胀,菌斑指数,出血指数,肉芽组织,化脓,再上皮化,触诊时出血,气味,和味道的改变。患者随访7天。
结果:所有114名入选患者完成了研究,没有辍学或失去随访。三组患者的平均年龄不同(H2O2和HA:30.9±14.9;安慰剂:27.6±13.1;0.2%氯己定:23.05±10.16)。与安慰剂组相比,在H2O2和HA组中观察到视觉模拟评分(VAS)疼痛水平和其他结果测量的显著降低(p<0.001)。这些发现表明H2O2和HA组合对第三磨牙手术后的窝愈合具有积极作用。
结论:该研究得出结论,过氧化氢和透明质酸的组合可以被认为是一种潜在的漱口水,对第三磨牙手术后的牙槽愈合具有有益作用。然而,我们建议进行更多临床试验以进一步验证其有效性,并提供更多证据支持其在临床应用.
背景:gov:NCT04438434。
OBJECTIVE: The
study aimed to investigate the potential beneficial role of hydrogen peroxide (H2O2) and hyaluronic acid (HA) combination formulation in socket healing after third molar surgery. Biomaterials, including mouthwash formulations, were hypothesized to contribute to improved socket healing and reduced post-operative complications.
METHODS: A triple-blinded parallel randomized controlled clinical
trial was conducted at a single-center dental hospital in Milan, Italy. The
trial included 114 patients who underwent extraction of impacted, partially erupted, and completely erupted third molars. Patients were randomly assigned to three parallel groups: Group 1 (H2O2 and HA), Group 2 (placebo), and Group 3 (0.2% chlorhexidine). The
trial was registered at ClinicalTrial.gov (registration number NCT04438434). The main outcome measures included various parameters related to socket healing, such as pain, inflammation, swelling, plaque index, bleeding index, granulation tissue, suppuration, re-epithelialization, bleeding upon palpation, odor, and taste alteration. Patients were followed up for 7 days.
RESULTS: All 114 enrolled patients completed the study, with no dropouts or loss to follow-up. The mean age of patients in the three groups differed (H2O2 and HA: 30.9±14.9; placebo: 27.6±13.1; 0.2% chlorhexidine: 23.05±10.16). Significant reductions (p<0.001) in visual analog scale (VAS) pain levels and other outcome measures were observed in the H2O2 and HA group compared to the placebo group. These findings suggest a positive effect of the H2O2 and HA combination on socket healing after the third molar surgery.
CONCLUSIONS: The
study concludes that the combination of hydrogen peroxide and hyaluronic acid can be considered a potential mouthwash with beneficial effects on socket healing following third molar surgery. However, additional clinical trials are recommended to validate its effectiveness further and provide additional evidence supporting its use in clinical settings.
BACKGROUND: gov: NCT04438434.