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双氧水和透明质酸在第三磨牙拔除后漱口液中的作用:一项三盲平行随机对照临床试验。

Effect of hydrogen peroxide and hyaluronic acid in mouth rinse after third molar extraction: a triple-blind parallel randomized controlled clinical trial.

机构信息

Department of Biomedical, Surgical, and Dental Science, University of Milan, Milan, Italy.

出版信息

Eur Rev Med Pharmacol Sci. 2024 Jul;28(13):3946-3957. doi: 10.26355/eurrev_202407_36527.

DOI:10.26355/eurrev_202407_36527
PMID:39012233
Abstract

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.

PATIENTS AND 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.

CLINICALTRIAL

gov: NCT04438434.

摘要

目的

本研究旨在探讨过氧化氢(H2O2)和透明质酸(HA)联合配方在第三磨牙手术后牙槽窝愈合中的潜在有益作用。生物材料,包括漱口剂配方,被假设可以促进牙槽窝愈合和减少术后并发症。

患者和方法

在意大利米兰的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。该试验纳入了 114 名接受埋伏、部分萌出和完全萌出第三磨牙拔除的患者。患者被随机分为三组:组 1(H2O2 和 HA)、组 2(安慰剂)和组 3(0.2%洗必泰)。该试验在 ClinicalTrials.gov 上注册(注册号 NCT04438434)。主要观察指标包括与牙槽窝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、上皮再形成、触诊时出血、异味和味觉改变。患者随访 7 天。

结果

所有 114 名入组患者均完成了研究,无脱落或失访。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%洗必泰:23.05±10.16)。与安慰剂组相比,H2O2 和 HA 组的视觉模拟评分(VAS)疼痛水平和其他观察指标均显著降低(p<0.001)。这些发现表明 H2O2 和 HA 联合使用对第三磨牙手术后牙槽窝愈合有积极影响。

结论

本研究表明,过氧化氢和透明质酸的联合使用可以被认为是一种潜在的漱口水,对第三磨牙手术后牙槽窝愈合有有益的影响。然而,建议进行更多的临床试验来进一步验证其有效性,并提供更多支持其在临床环境中使用的证据。

临床试验

gov:NCT04438434。

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