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评价含番石榴叶提取物的漱口液作为综合口腔护理方案的一部分 - 一项随机安慰剂对照临床试验。

Evaluation of a mouthrinse containing guava leaf extract as part of comprehensive oral care regimen- a randomized placebo-controlled clinical trial.

机构信息

Department of Periodontology, Manipal College of Dental Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.

Department of Microbiology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Karnataka, India.

出版信息

BMC Complement Altern Med. 2019 Nov 21;19(1):327. doi: 10.1186/s12906-019-2745-8.

Abstract

BACKGROUND

The control of biofilm adherence on tooth surface has always been the keystone of periodontal therapeutic systems. However, prevalence of gingivitis suggest inadequacy of self-performed oral hygiene measures and need for adjunctive aid for mechanical plaque control. Oral rinses containing chlorhexidine, has been widely used however, with certain limitations. Herbal products have been used widely reflecting its action as alternative and complementary remedy. Hence, the purpose of the present study was to evaluate the antimicrobial and antioxidant efficacy of a Guava leaf extract based mouthrinse in patients with chronic generalized gingivitis as an adjunct to oral prophylaxis.

METHODS

Sixty subjects (n = 20) in compliance with the inclusion criteria were randomly assigned to one of the 3 study groups i.e. Group A- 0.15%Guava mouth rinse, Group B- 0.2% Chlorhexidine (CHX) mouth rinse, Group C- Distilled water (placebo). All the participants received professional oral prophylaxis and were dispensed with experimental mouth rinses and instructed to use for period of 30 days. Clinical parameters such as gingival index, plaque index along with microbial colony forming units using plaque samples and antioxidant levels in saliva were estimated at baseline, 30 and 90 days' time intervals.

RESULTS

All 3 groups showed gradual reduction in GI, PI and microbial counts. Considering the mean scores of recorded parameters at the scheduled time intervals, notable changes were observed between chlorhexidine and guava mouth rinse compared to placebo group. Although there was improvement in the antioxidant status in all study participants, yet there was no statistically significant difference observed.

CONCLUSION

Guava mouth rinse can be used as an empirical adjunct to professional oral prophylaxis owing to its multifactorial properties and favourable acceptance. However, long term studies need to be conducted to validate its use for an extended period of time.

TRIAL REGISTRATION

The clinical trial has been prospectively registered on 17th February 2017 by the Clinical Trials Registry-India (CTRI/2017/02/007898).

摘要

背景

控制牙面生物膜附着一直是牙周治疗系统的关键。然而,牙龈炎的流行表明自我进行的口腔卫生措施不足,需要机械菌斑控制的辅助手段。含洗必泰的口腔冲洗剂已被广泛使用,但存在一定的局限性。草药产品已被广泛使用,反映了其作为替代和补充疗法的作用。因此,本研究的目的是评估基于番石榴叶的口腔冲洗剂在慢性广泛性牙龈炎患者中的抗菌和抗氧化功效,作为口腔预防的辅助手段。

方法

符合纳入标准的 60 名受试者(n=20)被随机分配到以下 3 个研究组之一:A 组-0.15%番石榴口腔冲洗剂,B 组-0.2%洗必泰(CHX)口腔冲洗剂,C 组-蒸馏水(安慰剂)。所有参与者均接受专业口腔预防,并给予实验性口腔冲洗剂,并指导其使用 30 天。在基线、30 天和 90 天的时间间隔内,使用菌斑样本评估临床参数(如牙龈指数、菌斑指数)和微生物菌落形成单位以及唾液中的抗氧化水平。

结果

所有 3 组的 GI、PI 和微生物计数均逐渐降低。考虑到记录参数的平均得分在预定的时间间隔内,与安慰剂组相比,洗必泰和番石榴口腔冲洗剂组观察到明显的变化。虽然所有研究参与者的抗氧化状态都有所改善,但没有观察到统计学上的显著差异。

结论

番石榴口腔冲洗剂可作为专业口腔预防的经验性辅助手段,因其具有多因素特性和良好的接受性。然而,需要进行长期研究来验证其在延长时间内的使用。

试验注册

该临床试验于 2017 年 2 月 17 日由印度临床试验注册处(CTRI/2017/02/007898)前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/836e/6873761/8654a9e3cb61/12906_2019_2745_Fig1_HTML.jpg

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