Acceptance and Efficacy of a Digital Application Among Parents to Control Early Childhood Caries

NCT05515510 | Completed DMC

• 1 other identifier: BB-097/20
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early Childhood Caries; Oral Hygiene; Oral Health

Keywords

digital application; parental knowledge; parental behaviour; self-reported practices; self-reported attitude

Outcome Measures

Primary Outcomes (3)

• Acceptance of the digital application

  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.

  Baseline

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

  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.

  2-4 weeks, and 3 months

• Change in acceptance of a digital application

  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.

  2-4 weeks, and 3 months

Secondary Outcomes (3)

• O'Leary Plaque Index

  Baseline and 3 months

• Papilla Bleeding Index (PBI)

  Baseline and 3 months

• dmft caries index

  Baseline and 3 months

Study Arms (2)

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.

Other: Oral health recommendations

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.

Other: FU-APP; Other: Oral health recommendations

Interventions

FU-APP OTHER

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.

Test

Oral health recommendations OTHER

Oral health recommendations provided as usual (verbal/oral) according to the current German "Ratgeber 2020"

Control; Test

Eligibility Criteria

• Age: 6 Months - 72 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Universitätmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, 17489, Germany

Location

Related Links

• The German "Ratgeber 2020" (Bundeszahnärztekammer 2019)

Study Officials

• Jameela Abdul Haq, MSc

  Universitätmedizin Greifswald

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm, care-based, controlled, randomized clinical trial (RCT) using questionnaires and intraoral assessment.

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: August 25, 2022
• Study Start: October 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)