Clinical trial NCT03935009: Learning Brushing Using Game Elements in Mobile Phones Apps
Official title: Learning Oral Hygiene Using Gamification: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Hygiene
Dental Plaque
Children, Only
Dental Devices, Home Care
Motivation
Learning
Keywords: Oral hygiene
Dental Plaque
Brushing
Flossing
Gamification
Game elements
Motivation
Education
Children
Parents
Lead sponsor: University Maribor
Sponsor class: OTHER
Collaborators: name: Playbrush GmbH
name: Flegis d.o.o.
name: Middle-sized public primary school Videm pri Ptuju
First posted: 2019-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to compare the efficacy of using gamification for oral hygiene in children at home environment.

Detailed description: Subjects will be randomized into three groups:

1. The first group will receive a manual toothbrush Curaprox 5460 ultra soft, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Chomper Chums.
2. The second group will receive electric toothbrush Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App.
3. The third group will receive electric toothbrush Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia.

Eligibility criteria: Inclusion Criteria:

* Children with secondary dentition (not completed);
* Children age 10 years and above and don't have mental or physical disabilities;
* Children brushing teeth by themselves;
* Children using manual or electric toothbrush;
* Children using a mobile phone;

Exclusion Criteria:

* Children with the fixed orthodontic appliance;
* Children above 14 years;

Primary outcomes:
measure: Control 1: Intrinsic motivation
timeFrame: Baseline
measure: Control 1: Oral hygiene index
timeFrame: Baseline
measure: Control 2: Intrinsic motivation
timeFrame: Two weeks after baseline
measure: Control 2: Oral hygiene index
timeFrame: Two weeks after baseline
measure: Control 3: Intrinsic motivation
timeFrame: Six weeks after baseline
measure: Control 3: Oral hygiene index
timeFrame: Six weeks after baseline
Secondary outcomes:
measure: Oral hygiene knowledge of participants 1
timeFrame: Baseline
measure: Oral hygiene knowledge of participants 2
timeFrame: Six weeks after baseline
Other outcomes:
measure: Indirect influence on oral hygiene of participants 1
timeFrame: Baseline
measure: Indirect influence on oral hygiene of participants 2
timeFrame: Six weeks after baseline
Locations:
city: Maribor
country: Slovenia
facility: University Maribor
city: Maribor
country: Slovenia
facility: University of Maribor Faculty of health sciences
Study officials:
affiliation: University Maribor
name: Nino Fijacko
role: STUDY_CHAIR
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