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临床试验/NCT05515510
NCT05515510已完成不适用

Acceptance and Efficacy of a Digital Application in Promoting Evidence Based Oral Hygiene Knowledge Among Parents to Control Early Childhood Caries

University Medicine Greifswald1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年10月1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
发起方
入组人数
66
试验地点
1
主要终点
Change in knowledge, behaviour and self-reported practices/attitude related to oral health preventive measures.

研究概览

简要总结

Few educational oral health applications, directed to the preschool children under the age of six years are available world-wide. The overall aim of this study is to evaluate the acceptance and efficacy of a digital application in improving evidence based oral hygiene knowledge among parents of young children to control Early Childhood Caries (ECC).

This study is split into two parts, the first one is aimed to understand the acceptance, usability and parental perception about a digital application being used to promote the evidence based oral hygiene knowledge among parents of young children to control ECC.

In a second phase (randomised clinical trial) the additional effect and acceptance of the digital application, and efficacy in improving parental knowledge, behaviour and self-reported practices/attitudes related to the oral health preventive measures will be presented.

详细描述

This two arm randomized cohort study is being undertaken at the Department of Preventive and Pediatric Dentistry at the University of Greifswald. Assessment of eligibility and application of intervention will be carried out by a single investigator (JH).

This study is being conducted in total in two phases. In the first, pilot phase - the digital application design, acceptance and parental perception will be assessed with the help of a questionnaire. In the second phase a two-arm controlled randomized clinical trial (RCT) will be conducted to assess the acceptance and efficacy of the application in improving parental knowledge, behaviour and self-reported practices/attitudes related to the oral health preventive measures. Clinically oral hygiene status and caries status of the participant children will be recorded too. The total appointment duration will also be measured.

Intervention:

Pilot study: After receiving the informed consent from the parents, the FU-APP digital application was shown to the parents attending the Department of Preventive and Pediatric Dentistry at the University of Greifswald for an oral health check-up on a tablet-PC. Once the parents have gained the experience of using the application and viewing the content, they were asked to fill out a user-acceptability questionnaire.

RCT: After receiving the informed consent from the parents, the child was seated on the dental chair for a normal check-up and the parents received the intervention according to the assigned arm in the form of information delivered. The information was based on the oral hygiene recommendations that followed the current German guidelines (counselling in diet, brushing instructions, and fluoride varnish application, nutrition and behavioural habits) according to the age of the child (Bundeszahnärztekammer 2020). Subsequently, parents in the test arm received additional information with the help of the web-based application (FU-APP) on a tablet-PC. Once the parents gained the experience of using the application and viewing the content, they were asked to fill out a knowledge-testing questionnaire in order to compare the knowledge at a follow up appointment. Parents in the control group also were asked to fill out the Questionnaire. Clinically oral hygiene status and caries status of the participant child were also recorded. For both arms, the follow-up visits took place 2 to 4 weeks and 3 months later and consisted of the same sequence of steps for the given intervention with modified questions included in the questionnaire to compare the improvement in oral health knowledge and the clinical records were recorded again to assess the improvement levels in the oral hygiene status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
6 Months 至 72 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Parents can fully understand German language.
  • •Parents of medically fit children aged 6 months - 72 months.
  • •Parents/children who attend the Department of preventive and Pediatric Dentistry of the University of Greifswald for an oral health check-up.
  • •Willingness to participate in the study.

排除标准

  • •Parents who visit the Department of preventive and Pediatric Dentistry of the University of Greifswald for an emergency treatment or pain.
  • •Parents who decline to participate in the study.

研究组 & 干预措施

Control

Active Comparator

Oral health prevention recommendations (frequency of brushing, technique, diet counselling, fluoride use, etc.) will be provided as usual by the dentist (verbal/oral) according to the current German "Ratgeber 2020" (KZBV,2029), which are implemented as standard oral health recommendation at the Department of Preventive and Pediatric Dentistry of Greifswald University.

Parents in the control group will be ask after the intervention, and at the recalls (between 2 and 12 weeks and 3 months), to answer a questionnaire in order to determine their knowledge, behaviour, attitudes and related oral health practices.

干预措施: Oral health recommendations (Other)

Test

Experimental

Oral health recommendations will be provided according to the current German "Ratgeber 2020" (KZBV,2029), which are implemented as standard at the Department of Preventive and Pediatric Dentistry of Greifswald University. Test arm receives this information with a digital application (FU-APP) in addition to the established oral health recommendation/instruction according to the current German "Ratgeber 2020" (KZBV,2020). After the intervention and at the recalls (between 2 and 12 weeks and 3 months), parents will be asked to answer two questionnaires in order to determine their FU-APP acceptance, knowledge, behaviour, attitudes and related practices.

干预措施: FU-APP (Other)

Test

Experimental

Oral health recommendations will be provided according to the current German "Ratgeber 2020" (KZBV,2029), which are implemented as standard at the Department of Preventive and Pediatric Dentistry of Greifswald University. Test arm receives this information with a digital application (FU-APP) in addition to the established oral health recommendation/instruction according to the current German "Ratgeber 2020" (KZBV,2020). After the intervention and at the recalls (between 2 and 12 weeks and 3 months), parents will be asked to answer two questionnaires in order to determine their FU-APP acceptance, knowledge, behaviour, attitudes and related practices.

干预措施: Oral health recommendations (Other)

结局指标

主要结局

Change in knowledge, behaviour and self-reported practices/attitude related to oral health preventive measures.

时间窗: 2-4 weeks, and 3 months

The questionnaire will be used to test change in knowledge, behavior and self-reported practices, attitude related to oral health preventive measures after having used the FU-APP. The options will be provided in the form of multiple choice.

Acceptance of the digital application

时间窗: Baseline

The pre-tested questionnaire will be used to test the overall acceptance level of the FU-APP. Answers will be as 5-point- Likert Scale (Completely agree, partially agree, neutral, partially disagree, completely disagree) presented. The questionnaire includes different categories: usage, acceptance, content description, usefulness and satisfaction.

Change in acceptance of a digital application

时间窗: 2-4 weeks, and 3 months

The questionnaire will be used to test the overall acceptance level (usage, content description, usefulness and satisfaction) of the FU-APP. Answers will be as 5-point- Likert Scale (Completely agree, partially agree, neutral, partially disagree, completely disagree) presented.

次要结局

  • O'Leary Plaque Index(Baseline and 3 months)
  • Papilla Bleeding Index (PBI)(Baseline and 3 months)
  • dmft caries index(Baseline and 3 months)

研究者

发起方
University Medicine Greifswald
申办方类型
Other
责任方
Sponsor

研究点 (1)

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