"Effectiveness and Adherence to Toothbrushing Habits of Preschool Children, Using Manual or Powered Toothbrushes With or Without a Toothbrushing Assisting Application"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 12
- 主要终点
- Change from baseline of Gingival Index score in one month
研究概览
简要总结
The aim of this study is to investigate the effectiveness of the use of a toothbrushing assisting mobile application in dental plaque removal and adherence to the toothbrushing routine, in preschool children (3-5 yrs old) when brushing with either manual or powered toothbrush.
Objectives: To identify the effectiveness in dental plaque control in relation to the following parental characteristics:
- Sociodemographic (area of residence, average income, education level)
- Oral Health status
- Oral Health Literacy
- Parenting style
- Parental oral hygiene practices
详细描述
This is a single blind randomized clinical trial with 6 months follow up that involves:
- Written parental informed consent for their child's participation in the study
- Completion of self-administered parental questionnaires on: (i) medical and dental history of the child, demographics, parental attitudes and oral hygiene practices, and child's diet and oral hygiene practices and (ii) Parenting style, using Parenting Styles Dimensions Questionnaire (PSDQ)
- Completion, by face-to-face interview, of the Oral Health Literacy instrument (GROHL) validated for Greek language.
- Oral hygiene and toothbrushing instructions to both parents and children
- Toothbrushing at home using manual or powered toothbrushes with and without the use of a toothbrushing assisting app.
- Dental examination of the children regarding oral hygiene status (plaque), gingivitis and dental caries, pre and post the intervention period.
Sample: Parent-child dyads will be recruited from pre-schools in areas of various socio-economic status of Attica. To avoid recruiting the same parent twice, only one child from each family will be recruited as long as the child fulfils the above criteria
Procedures -Informed Consent and Questionnaires:
Prior to the school examination date, written consent forms and questionnaires will be sent to the parents of all groups and will be returned to the school completed in order for the children to take part in the examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
A unique trial identification number (trial ID) will be generated for each participant, details of which will be entered into the trial management system.
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children 3-5 years of age
- •good general health
- •born in Greece and understand Greek language
- •at least 16 fully erupted primary teeth with facial and lingual surfaces that can be scored (erupting teeth will not be scored).
- •living in the same household with the parent consenting for participation in the study
排除标准
- •any medical condition or medications that affect gingival condition (e.g. antiepileptics)
- •tooth surfaces that plaque cannot be scored due to extensive carious lesions
- •presence of abscess or fistula , pain or need for urgent dental treatment
- •difficulties in communication due to language issues
- •lack of cooperation
- •use of powered toothbrush in the past
结局指标
主要结局
Change from baseline of Gingival Index score in one month
时间窗: one month
Gingivitis according to Gingival Index (GI) by Löe - Silness, on 6 sites of teeth.Scoring criteria for GI are 0=Normal gingival, 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 for spontaneous bleeding.
Change from baseline of Calculus Index score in one month
时间窗: one month
Will be recorded using Calculus Surface Index (CSI). Presence (=0) or absence (=1) of calculus on the lingual surface of the lower 4 anterior teeth will be assessed by visual examination with mouth mirror and the percentage of the surfaces with calculus to those examined in total will be recorded for each individual
Change from baseline of mean Plaque score in one month
时间窗: one month
According to TURESKY QUIGLEY/HEIN plaque index: '0' = No plaque present, '1' = Separate flecks of plaque at the cervical margin, '2' = A thin continuous band of plaque (up to 1 mm) at the cervical margin,'3'= A band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth. '4' = Plaque covering at least one-third but less than two-thirds of the side of crown of the tooth, '5' = Plaque covering two-thirds or more of the side of the crown of the tooth.
Change in times of brushing in one month
时间窗: one month
Will be collected via a checklist
Change from baseline of Gingival Index score in six months
时间窗: six months
Gingivitis according to Gingival Index (GI) by Löe - Silness, on 6 sites of teeth.Scoring criteria for GI are 0=Normal gingival, 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 for spontaneous bleeding.
Change from baseline of Calculus Index score in six months
时间窗: six months
Will be recorded using Calculus Surface Index (CSI). Presence (=0) or absence (=1) of calculus on the lingual surface of the lower 4 anterior teeth will be assessed by visual examination with mouth mirror and the percentage of the surfaces with calculus to those examined in total will be recorded for each individual
Change from baseline of mean Plaque score in six months
时间窗: six months
According to TURESKY QUIGLEY/HEIN plaque index: '0' = No plaque present, '1' = Separate flecks of plaque at the cervical margin, '2' = A thin continuous band of plaque (up to 1 mm) at the cervical margin,'3'= A band of plaque wider than 1 mm but covering less than one-third of the side of the crown of the tooth. '4' = Plaque covering at least one-third but less than two-thirds of the side of crown of the tooth, '5' = Plaque covering two-thirds or more of the side of the crown of the tooth.
Change in times of brushing in six month
时间窗: six months
Will be collected via a checklist
次要结局
- Change from baseline in mean dmft score in 6 months(six months)
研究者
Sofia Gkourtsogianni
Principal Investigator
National and Kapodistrian University of Athens