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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Learning Brushing Using Game Elements in Mobile Phones Apps

Clinicaltrials.gov identifier NCT03935009

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted May 2, 2019

Study Description

Brief summary:

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

  • Condition or Disease:Dental Plaque
    Children, Only
    Oral Hygiene
    Dental Devices, Home Care
    Motivation
    Learning
  • Intervention/Treatment: Behavioral: Manual toothbrush Curaprox 5460 ultra soft
    Behavioral: Electric toothbrush Play Smart Brush N°1
    Behavioral: Electric toothbrush Play Smart Brush N°2
  • Phase: N/A
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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Investigator)
  • Primary Purpose: Prevention
  • Official Title: Learning Oral Hygiene Using Gamification: a Randomized Clinical Study
  • Estimated Study Start Date: May 2019
  • Estimated Primary Completion Date: July 2019
  • Estimated Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
Active Comparator: Manual toothbrush with electric toothbrush N°1
Participants will receive manual toothbrush (Curaprox 5460 ultra soft, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Chomper Chums) and an electric toothbrush N°1 (Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App) and will be instructed to use them for six weeks.
Behavioral: Manual toothbrush Curaprox 5460 ultra soft
Soft manual toothbrush (Curaprox 5460 ultra soft) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Chomper Chumswill will be used to brush teeth.

Behavioral: Electric toothbrush Play Smart Brush N°1
Electric toothbrush (Play Smart Brush N°1) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App will be used to brush teeth.
Active Comparator: Manual toothbrush with electric toothbrush N°2
Participants will receive manual toothbrush (Curaprox 5460 ultra soft, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Chomper Chums) and an electric toothbrush N°2 (Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia) and will be instructed to use them for six weeks.
Behavioral: Manual toothbrush Curaprox 5460 ultra soft
Soft manual toothbrush (Curaprox 5460 ultra soft) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Chomper Chumswill will be used to brush teeth.

Behavioral: Electric toothbrush Play Smart Brush N°2
Electric toothbrush (Play Smart Brush N°2) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia will be used to brush teeth.
Active Comparator: Electric toothbrush N°1 with electric toothbrush N°2
Participants will receive an electric toothbrush N°1 (Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App) and an electric toothbrush N°2 (Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia) and will be instructed to use them for six weeks.
Behavioral: Electric toothbrush Play Smart Brush N°1
Electric toothbrush (Play Smart Brush N°1) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App will be used to brush teeth.

Behavioral: Electric toothbrush Play Smart Brush N°2
Electric toothbrush (Play Smart Brush N°2) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia will be used to brush teeth.
Outcome Measures
  • Primary Outcome Measures: 1. Control 1: Intrinsic motivation [ Time Frame: Baseline ]
    The investigators will be using the Intrinsic Motivation Inventory (IMI) for measuring the participant intrinsic motivation (McAuley, Duncan, & Tammen, 1987). The IMI will have in total 37 items, measured on a 7-point scale.
  • 2. Control 1: Oral hygiene index [ Time Frame: Baseline ]
    The investigators will be using the Oral Hygiene Index (OHI) for measuring the participant debris Index (DI) and Calculus Index (CI) (Greene and Vermillion, 1960). Each index has a scale from 0 to 3. After the scores for DI and CI are recorded, the OHI (OHI range from 0 to 12) values are calculated. Higher the OHI, poorer is the oral hygiene of the participant.
  • 3. Control 2: Intrinsic motivation [ Time Frame: Two weeks after baseline ]
    The investigators will be using the Intrinsic Motivation Inventory (IMI) for measuring the participant intrinsic motivation (McAuley, Duncan, & Tammen, 1987). The IMI will have in total 37 items, measured on a 7-point scale.
  • 4. Control 2: Oral hygiene index [ Time Frame: Two weeks after baseline ]
    The investigators will be using the Oral Hygiene Index (OHI) for measuring the participant debris Index (DI) and Calculus Index (CI) (Greene and Vermillion, 1960). Each index has a scale from 0 to 3. After the scores for DI and CI are recorded, the OHI (OHI range from 0 to 12) values are calculated. Higher the OHI, poorer is the oral hygiene of the participant.
  • 5. Control 3: Intrinsic motivation [ Time Frame: Six weeks after baseline ]
    The investigators will be using the Intrinsic Motivation Inventory (IMI) for measuring the participant intrinsic motivation (McAuley, Duncan, & Tammen, 1987). The IMI will have in total 37 items, measured on a 7-point scale.
  • 6. Control 3: Oral hygiene index [ Time Frame: Six weeks after baseline ]
    The investigators will be using the Oral Hygiene Index (OHI) for measuring the participant debris Index (DI) and Calculus Index (CI) (Greene and Vermillion, 1960). Each index has a scale from 0 to 3. After the scores for DI and CI are recorded, the OHI (OHI range from 0 to 12) values are calculated. Higher the OHI, poorer is the oral hygiene of the participant.
  • Secondary Outcome Measures: 1. Oral hygiene knowledge of participants 1 [ Time Frame: Baseline ]
    The investigators will use a questionnaire (Poutanen et al., 2007) about demographic factors and oral health-related knowledge attitudes, belief, and behavior to get information about the knowledge of participants oral health. Knowledge, attitudes, and beliefs are measured with 4-point Likert-scale questions; the alternatives were: strongly agree, partly agree, partly disagree, strongly disagree. Behaviors are measured with 7-point Likert-scale questions with alternatives that described the frequency of the behavior.
  • 2. Oral hygiene knowledge of participants 2 [ Time Frame: Six weeks after baseline ]
    The investigators will use a questionnaire (Poutanen et al., 2007) about oral health-related knowledge attitudes, belief, and behavior to get information about the knowledge of participants oral health. Knowledge, attitudes, and beliefs are measured with 4-point Likert-scale questions; the alternatives were: strongly agree, partly agree, partly disagree, strongly disagree. Behaviors are measured with 7-point Likert-scale questions with alternatives that described the frequency of the behavior.
  • Other Outcome Measures: 1. Indirect influence on oral hygiene of participants 1 [ Time Frame: Baseline ]
    The investigators will use a combination of a different questionnaire from research (D'Cruz & Aradhya, 2012; de Silva-Sanigorski et al., 2013; Ramesh Kumar et al., 2013; Eden et al., 2018) about oral health to get information about the indirect influence on the oral hygiene of participants.
  • 2. Indirect influence on oral hygiene of participants 2 [ Time Frame: Six weeks after baseline ]
    The investigators will use a combination of a different questionnaire from research (D'Cruz & Aradhya, 2012; de Silva-Sanigorski et al., 2013; Ramesh Kumar et al., 2013; Eden et al., 2018) about oral health to get information about the indirect influence on the oral hygiene of participants.
Eligibility Criteria
  • Ages Eligible for Study: 10 to 14 Years (Child)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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;

Contacts and Locations
Contacts

Contact: Nino Fijacko +38623004764 nino.fijacko@um.si

Contact: Gregor Stiglic +38623004731 gregor.stiglic@um.si

Locations

Slovenia
University Maribor
Maribor

Slovenia
University of Maribor Faculty of health sciences
Maribor

Sponsors and Collaborators

University Maribor

Playbrush GmbH

Flegis d.o.o.

Middle-sized public primary school Videm pri Ptuju

Investigators

Study Chair: Nino Fijacko University Maribor

More Information