Acceptance and Efficacy of a Digital Application Among Parents to Control Early Childhood Caries
Condition: Early Childhood Caries; Oral Hygiene; Oral Health
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Hypothesis:

      The acceptance, usability and parental perception of a digital application (FU-APP) developed
      to promote evidence based oral hygiene knowledge among parents of young children to control
      ECC is positive and there is an additional positive effect in improving parental knowledge,
      behavior and self-reported practices/attitudes related to the oral health preventive measures
      while testing the efficacy of the FU-APP.

      Application development:

      An account is made on a certified online web-development platform and an application is
      developed on it. It will provide information related to oral health care for the parents of
      children between 6 to 72 months of age. FU application will be a web based application using
      guidelines and recommendations provided by the current German "Ratgeber 2020".

      Sample size calculation:

      Pilot study: Purposive sample including N = 20 parents of medically fit children aged between
      6 months to 72 months.

      RCT: The sample size was calculated assuming a difference of 0,5 between groups at
      follow-ups, setting α=5% and power (1-ß)=0.80 resulting in 28 children for every group.
      Adding an expected drop-out of 15%, a total sample size of 33 in every group (test and
      control) is needed.

      Randomisation and allocation concealment:

      Participants will be randomised through a computer-generated random-number list with
      allocation concealment to 1 of the 2 arms. Proper allocation concealment will be assured by a
      second investigator (RS), different to the investigator in charge of participants recruiting
      (JH). This investigator will have no possibility of knowing, which participant will go in
      which group avoiding influence on the randomisation.

      Statistical analysis:

      Part 1 - Pilot Data was primarily recorded on a spreadsheet Microsoft Excel (2017), then
      analysed using SPSS version 27. Spearman's correlation coefficient was applied to assess the
      strength of association between overall satisfaction and usage, acceptance, content and
      usefulness of the FU-App. Kruskal-Wallis analysis of variance and the non-parametric
      Mann-Whitney U test were applied to assess differences between FU category and overall
      satisfaction. P-value≤0.05 was taken as statistically significant.

      Part 2 - Normality was checked for quantitative variables. Comparisons between the test and
      control were done using independent samples t-test, or Mann-Whitney U test for quantitative
      variables (according to the variable normality), while comparisons of qualitative variables
      were done using chi-square and Fisher exact tests, with Monte Carlo correction whenever
      indicated. Comparing the baseline and follow-up in each group was done using Wilcoxon signed
      rank and Mc-Nemar tests. Significance was inferred at p value <0.05. Data were analysed using
      IBM-SPSS for Windows (v. 23.0).

      Quality assurance information:

      Quality Assurance consisted of multiple steps in order to maintain a standard protocol during
      the study. As a first step, standard guidelines were set up for the data collection process
      through consensus by FU-Team. Secondly a detailed recruitment plan was developed to
      strategize and be aligned on the recruitment and data collection. Lastly the final step was
      to monitor and evaluate the process in the study field during the data collection and along
      with it identify the areas of improvement to strengthen the study further.

      Standard procedures were used to ensure accurate and consistent measurements throughout the
      study. Standardized training was done in order to be familiar with the navigation of the
      FU-APP. Principal investigator (JH) was trained to conduct recruitment, measurement, and data
      collection for the RCT. The Principal investigator (JH) participated in a Quality Assurance
      (QA) training before starting the recruitment process. The training reviewed all data
      collection components and consisted of standardized measurements to minimize error. The
      training held before the follow-up sessions also included a mock data collection session.

      The collected data information and documents were stored securely in the cabinets at the
      University Department. The consent forms and questionaries were filed properly in a
      customized folder designed and allocated to each recruited study participant. At the follow
      up appointment further documents were filed in the same individualized folder ensuring that
      each study participant had a customized protected folder and all quality assurance protocols
      are met. Only the principal investigator and study supervisors had the access to study
      participant's customized folders. Each study participant also received a copy of consent form
      and the confirmation form of willingness to participate in the study.
    

Intervention name(s): FU-APP; Oral health recommendations
Intervention type(s): Other; Other
Intervention description(s): FU-APP is a web-based application using the guidelines and oral health recommendations provided by the current German "Ratgeber 2020". It provides information related to oral health care for the parents of children between 6 to 72 months of age. An account was made on a certified online web-development platform and an application was developed on it.
This application serves as a practical guide for the parents of children under 6 years of age. It provides all the essential German guidelines related to first dental visits, expected dental findings, practical brushing technique steps, plaque disclosing activity, motivational brushing video, nutritional facts and behavioral habits to be avoided. It is a complete package of essential information and with high quality content that promotes prevention of ECC at an early age.; Oral health recommendations provided as usual (verbal/oral) according to the current German "Ratgeber 2020"
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two arm, care-based, controlled, randomized clinical trial (RCT) using questionnaires and intraoral assessment.
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: digital application; parental knowledge; parental behaviour; self-reported practices; self-reported attitude