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临床试验/NCT03989427
NCT03989427已完成不适用

The Effectiveness of Brushing and Flossing Sequence on Control of Plaque and Gingival Inflammation-A Randomized Controlled Clinical Trial in Klinik Pergigian, MMMC, Melaka

Melaka Manipal Medical College2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change From Baseline in Mean BPI Index Scores at 2 Weeks

研究概览

简要总结

This study evaluates the effectiveness of brushing and flossing sequence in the control of dental plaque and gingival inflammation.

详细描述

Periodontal disease is the disease of the supporting dental tissues like alveolar bone,periodontal ligament cementum and gingiva. The most common form is plaque-induced gingivitis . Bleeding on gingival probing is one of the hallmarks of gingival inflammation.The removal of dental plaque is the most crucial action for preventing and treating gingival inflammation. Toothbrush along with toothpaste are still the most reliable means of plaque control. However, cleaning should be thorough and performed at regular intervals.

Toothbrush has a limited ability to reach all the areas around the tooth. Inter-dental areas are prone for plaque accumulation and gingival inflammation. Dental floss is one of the most effective tool in addition to tooth brush to remove inter-dental plaque. The sequence of using toothbrush and dental floss may influence the removal of dental plaque and consequently reducing the bleeding on probing of gingiva. There is conflicting evidence in the literature. The hypothesis of this study is that the sequence of brushing and flossing will not influence control of plaque control and gingival inflammation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will record measurements at baseline and post intervention. The assessor will be blinded from the sequence of intervention allocation.

入排标准

年龄范围
18 Years 至 28 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Dental students of Dental school of Melaka-Manipal Medical College

排除标准

  • Participants who had systemic diseases
  • Gingivitis or periodontitis
  • Use of antibiotics in the past 3 months,
  • Pregnancy,
  • Orthodontic appliances.

结局指标

主要结局

Change From Baseline in Mean BPI Index Scores at 2 Weeks

时间窗: Baseline and 2 weeks

Bleeding on probing (BOP) is an objective indicator of inflammation. BPI (Bleeding Point Index) is a validated index used to measure BOP. BOP is determined at the buccal, lingual and proximal surfaces of all teeth using BPI scores. BPI scores are measured at baseline and 2 weeks, followed by a wash out period of one week. BPI score is measured again at baseline and 2 weeks after cross over in intervention. Change in BPI scores will give the estimation of effect of the intervention. BPI score- minimum value is 0% and Maximum is 100% of bleeding surfaces in each individual patient with teeth. A positive error means that the predicted value is larger than the true value, and a negative error means that the predicted value is less than the true value. The mean error should be close to zero. Sometimes it will be negative or positive depending on the population.. Higher mean score is poor outcome. However, higher reduction in mean score compared to baseline is better outcome.

次要结局

  • Change From Baseline in Mean RMNPI Index Score at 2 Weeks(Baseline and 2 weeks)

研究者

发起方
Melaka Manipal Medical College
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rajesh Hosadurga

Professor

Melaka Manipal Medical College

研究点 (2)

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