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比较含proxabrushes牙刷与普通牙刷以及仅使用普通牙刷对泰国老年人口腔健康贡献的多中心随机对照试验。

Multicenter Randomized Controlled Trial Comparing the Contribution of Proxabrushes with Regular Toothbrushes and Only Regular Toothbrushes to the Oral Health of Thai Elderly.

作者信息

Gururatana Orachad, Vejvithee Warangkana, Ekpatcha Narisa

机构信息

Strategy and Quality Assurance Division, Sirindhorn College of Public Health, 29 Wachiraprakarn Road, Chonburi 20000, Thailand.

Department of Health, Ministry of Public Health, Nonthaburi, Thailand.

出版信息

Int J Dent. 2022 Mar 31;2022:5323092. doi: 10.1155/2022/5323092. eCollection 2022.

Abstract

OBJECTIVE

The aim of this two-group experimental study was to explore the effects of proxabrush on Thai elderly oral health. . Multicenter randomized controlled trial, parallel grouped, open label, blocked randomization was used at each province to allocate treatment. The study was conducted at public hospitals in 16 provinces in Thailand between November 2019 and January 2020.

METHODS

Participants in the test group used proxabrushes and regular toothbrushes, and participants in the control group used only regular toothbrushes for 6 weeks. Plaque accumulation, gingival status, and oral healthcare data were collected at baseline and at 6-week follow-up. Clinical oral health examiner was blinded to group assignment. Randomization was computer-generated, with allocation concealment by opaque sequentially number sealed envelopes. Data analysis compared plaque and gingival indices between the test and control groups.

RESULTS

A total of 510 elderly with at least 20 natural teeth and interdental spaces were randomized (test  = 255; control  = 255), and 35 were excluded from analysis because of early drop out leaving 239 in the test group and 236 in the control group. A sample of 475 aged between 60 and 91 years participated in the study; 158 (33.3%) were males and 317 (66.7%) were females. The results revealed that, compared to baseline knowledge, attitude and practice were improved at follow-up for both the test and control groups ( < 0.05). At follow-up, the independent-samples -test compares the test group plaque index mean of 0.49 (SD 0.44) to the control group mean of 0.60 (SD 0.56); a mean difference of 0.11 (95% CI 0.02 to 0.20) obtained demonstrated statistical significance ( = 0.014), and comparing the test group gingival index mean of 0.52 (SD 0.50) to the control group mean of 0.65 (SD 0.60), a mean difference of 0.13 (95% CI 0.03 to 0.23) obtained demonstrated statistical significance ( = 012). At follow-up, the test group had lower plaque accumulation and better gingival status than the control group. Gender, medical problems, educational level, occupation, and age were not different between the test and control groups. A combination of daily proxabrush and regular toothbrush use yielded significant benefits over regular tooth-brushing alone.

CONCLUSIONS

In conclusion, proxabrush has been found to be an effective interdental cleaning aid among Thai elderly. This trial is registered with TCTR20220127004.

摘要

目的

本两组实验研究旨在探讨牙间隙刷对泰国老年人口腔健康的影响。采用多中心随机对照试验,平行分组,开放标签,在每个省份进行区组随机化以分配治疗。该研究于2019年11月至2020年1月在泰国16个省份的公立医院进行。

方法

试验组参与者使用牙间隙刷和普通牙刷,对照组参与者仅使用普通牙刷,为期6周。在基线和6周随访时收集牙菌斑堆积、牙龈状况和口腔保健数据。临床口腔健康检查人员对分组情况不知情。随机化由计算机生成,通过不透明的顺序编号密封信封进行分配隐藏。数据分析比较了试验组和对照组之间的牙菌斑和牙龈指数。

结果

共有510名至少有20颗天然牙和牙间隙的老年人被随机分组(试验组=255;对照组=255),35人因早期退出被排除在分析之外,试验组剩余239人,对照组剩余236人。475名年龄在60至91岁之间的样本参与了研究;158名(33.3%)为男性,317名(66.7%)为女性。结果显示,与基线知识相比,试验组和对照组在随访时的态度和行为均有所改善(P<0.05)。在随访时,独立样本t检验比较试验组牙菌斑指数均值为0.49(标准差0.44)与对照组均值0.60(标准差0.56);获得的平均差值为0.11(95%置信区间0.02至0.20),具有统计学意义(P=0.014),比较试验组牙龈指数均值0.52(标准差0.50)与对照组均值0.65(标准差0.60),获得的平均差值为0.13(95%置信区间0.03至0.23),具有统计学意义(P=0.012)。在随访时,试验组的牙菌斑堆积低于对照组,牙龈状况更好。试验组和对照组在性别、医疗问题、教育水平、职业和年龄方面没有差异。每天联合使用牙间隙刷和普通牙刷比单独使用普通牙刷有显著益处。

结论

总之,已发现牙间隙刷对泰国老年人是一种有效的牙间隙清洁辅助工具。本试验已在泰国临床试验注册中心注册,注册号为TCTR20220127004。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9faf/8989556/36efd30e42fd/IJD2022-5323092.001.jpg

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