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临床试验/NCT03547531
NCT03547531已完成不适用

Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal in Children Aged 10-12 Years Old

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2017年8月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Baseline Plaque Level

研究概览

简要总结

  1. Plaque level in subjects using the Modified Circular method is different from that in subjects using natural tooth brushing method.
  2. Gingivitis level in subjects using the Modified Circular method is different from that in subjects using natural tooth brushing method.
  3. Level of plaque after using the Modified Circular method is different from that before using the method.
  4. Level of gingivitis after using the Modified Circular method is different from that before using the method.

详细描述

Dental caries and gingivitis prevalences in schoolchildren in Indonesia is high. Dental diseases can potentially caused missed school, concentration disturbance, impaired speech, poor self-esteem, and systemic illness. Caries and gingivitis can be prevented by maintaining oral hygiene. Toothbrushing is one of oral hygiene method to remove and prevent dental plaque that can cause dental caries and gingivitis. The aim of the study was to compare the level of plaque and gingivitis of children aged 10-12 years old that use the Modified Circular and natural tooth brushing methods.

One hundred and twenty four students from two state elementary school in Yogyakarta, Indonesia participated in this study. The age of the participants were between 10 and 12 years old including males and females students. All of the participants were fifth graders from two elementary schools. To be eligible to participate in this study, each participants met the criteria including: students with age 10 to 12 years old and willing as well as permitted by the parents/guardian to join thorough the study. The exclusion criteria were being diagnosed having developmental disorder, using orthodontic appliances, and using antiseptic mouthwash for daily use.

The study began with the baseline data collection. Then it continued with the training for the participants about improving the oral hygiene. Children will be instructed to brush their teeth two times a day in the morning and before bedtime with the duration of 2 minutes. The project provided one toothpaste and one toothbrush for each children. In this stage, the intervention group was demonstrated and instructed to brush their teeth using Modified Circular method, while the control group was not given any instruction to brush their teeth using a specific tooth brushing method and asked to brush their teeth using the way they brushing every day. The period of intervention was started after training and lasted for one month. In intervention period, intervention group was observed once a week to ensure that they brushed their teeth correctly using Modified Circular method. Finally the evaluation was implemented after 1 month of intervention. The duration of the trial was one month, started in 2 August 2017 and finished on 6 September 2017, and the study was finished in time.

This study did not use any invasive treatment due to oral examination. No drugs or chemical materials were used except nontoxic disclosing agent that was used only 2-3 drops for staining the dental plaque. The colors of disclosing agent will gradually disapear and easily removed by brushing.

The benefit of this study was to help teachers, parents, and students to know the level of oral cleanliness and the effective method of toothbrushing in order to maintain oral hygiene and prevent dental caries and gingivitis.

研究设计

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

盲法说明

Examiner was blind to the allocation of the group

入排标准

年龄范围
10 Years 至 12 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Students with age 10 to 12 years old and willing as well as permitted by the parents/guardian to join thorough the study.

排除标准

  • •Being diagnosed having developmental disorder, using orthodontic appliances, and using antiseptic mouthwash for daily use.

研究组 & 干预措施

Natural Tooth Brushing Method

Active Comparator

Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.

干预措施: Natural Tooth Brushing Method (Other)

Modified Circular Tooth Brushing Method

Experimental

Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.

干预措施: Modified Circular Tooth Brushing Method (Other)

结局指标

主要结局

Baseline Plaque Level

时间窗: Baseline

Plaque level is examined using "Turesky Modification of Quigley-Hein Index". The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces).

Baseline Gingival Condition

时间窗: Baseline

The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria: 0= Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).

Plaque Level at 1 Month

时间窗: one month after baseline data collection

Plaque level is examined using "Turesky Modification of Quigley-Hein Index". The scale is ranged from 0 to 5. 0 means no dental plaque existed on the tooth surface. 5 means all of the tooth surface is covered by dental plaque from the area that is closest to gingival to the occlusal area. The higher number of scores means worse. This index examines the buccal and lingual/palatal surfaces of the teeth (each teeth examined in 2 surfaces).

Gingival Condition at 1 Month

时间窗: one month after baseline data collection

The examination of gingival condition was using the Gingival Index by Silness and Loe. A score between 0 and 3 was given based on the criteria: 0= Normal gingiva. 1. Mild inflammation - slight change in color, slight edema. No bleeding on probing. 2. Moderate inflammation - redness, edema and glazing. Bleeding on probing. 3. Severe inflammation - marked redness and edema. Ulceration. Tendency to spontaneous bleeding. This scale examine each teeth in 4 surfaces (mesial, distal, buccal, lingual/palatal).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Istiyanti Hapsari

Comparison of Modified Circular and Natural Tooth Brushing Methods in Effectiveness of Dental Plaque Removal in Children Aged 10-12 Years Old

Prince of Songkla University

研究点 (1)

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