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Learning Brushing Using Game Elements in Mobile Phones Apps (GAMIFYBRUSH)

Primary Purpose

Oral Hygiene, Dental Plaque, Children, Only

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Manual toothbrush Curaprox 5460 ultra soft
Electric toothbrush Play Smart Brush N°1
Electric toothbrush Play Smart Brush N°2
Sponsored by
University Maribor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Hygiene focused on measuring Oral hygiene, Dental Plaque, Brushing, Flossing, Gamification, Game elements, Motivation, Education, Children, Parents

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • University MariborRecruiting
  • University of Maribor Faculty of health sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Manual toothbrush with electric toothbrush N°1

Manual toothbrush with electric toothbrush N°2

Electric toothbrush N°1 with electric toothbrush N°2

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Control 1: Intrinsic motivation
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.
Control 1: Oral hygiene index
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.
Control 2: Intrinsic motivation
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.
Control 2: Oral hygiene index
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.
Control 3: Intrinsic motivation
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.
Control 3: Oral hygiene index
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

Oral hygiene knowledge of participants 1
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.
Oral hygiene knowledge of participants 2
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.

Full Information

First Posted
April 16, 2019
Last Updated
April 29, 2019
Sponsor
University Maribor
Collaborators
Playbrush GmbH, Flegis d.o.o., Middle-sized public primary school Videm pri Ptuju
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1. Study Identification

Unique Protocol Identification Number
NCT03935009
Brief Title
Learning Brushing Using Game Elements in Mobile Phones Apps
Acronym
GAMIFYBRUSH
Official Title
Learning Oral Hygiene Using Gamification: a Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Maribor
Collaborators
Playbrush GmbH, Flegis d.o.o., Middle-sized public primary school Videm pri Ptuju

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. The second group will receive electric toothbrush Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App. The third group will receive electric toothbrush Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual toothbrush with electric toothbrush N°1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Manual toothbrush with electric toothbrush N°2
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Electric toothbrush N°1 with electric toothbrush N°2
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Manual toothbrush Curaprox 5460 ultra soft
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Electric toothbrush Play Smart Brush N°1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Electric toothbrush Play Smart Brush N°2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Control 1: Intrinsic motivation
Description
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.
Time Frame
Baseline
Title
Control 1: Oral hygiene index
Description
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.
Time Frame
Baseline
Title
Control 2: Intrinsic motivation
Description
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.
Time Frame
Two weeks after baseline
Title
Control 2: Oral hygiene index
Description
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.
Time Frame
Two weeks after baseline
Title
Control 3: Intrinsic motivation
Description
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.
Time Frame
Six weeks after baseline
Title
Control 3: Oral hygiene index
Description
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.
Time Frame
Six weeks after baseline
Secondary Outcome Measure Information:
Title
Oral hygiene knowledge of participants 1
Description
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.
Time Frame
Baseline
Title
Oral hygiene knowledge of participants 2
Description
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.
Time Frame
Six weeks after baseline
Other Pre-specified Outcome Measures:
Title
Indirect influence on oral hygiene of participants 1
Description
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.
Time Frame
Baseline
Title
Indirect influence on oral hygiene of participants 2
Description
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.
Time Frame
Six weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nino Fijacko
Phone
+38623004764
Email
nino.fijacko@um.si
First Name & Middle Initial & Last Name or Official Title & Degree
Gregor Stiglic
Phone
+38623004731
Email
gregor.stiglic@um.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nino Fijacko
Organizational Affiliation
University Maribor
Official's Role
Study Chair
Facility Information:
Facility Name
University Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nino Fijacko
Phone
+38623004764
Email
nino.fijacko@um.si
First Name & Middle Initial & Last Name & Degree
Gregor Stiglic
Phone
+38623004731
Email
gregor.stiglic@um.si
Facility Name
University of Maribor Faculty of health sciences
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nino Fijacko
Phone
+38623004764
Email
nino.fijacko@um.si
First Name & Middle Initial & Last Name & Degree
Gregor Stiglic
Phone
+38623004731
Email
gregor.stiglic@um.si

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol and all data will be part of the published article in the journal.
IPD Sharing Time Frame
IPD will be available after publishing an article in the journal.
IPD Sharing Access Criteria
No special criteria.
IPD Sharing URL
https://sites.google.com/view/zobek
Citations:
PubMed Identifier
21612316
Citation
Acharya S, Goyal A, Utreja AK, Mohanty U. Effect of three different motivational techniques on oral hygiene and gingival health of patients undergoing multibracketed orthodontics. Angle Orthod. 2011 Sep;81(5):884-8. doi: 10.2319/112210-680.1. Epub 2011 May 25.
Results Reference
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PubMed Identifier
30596050
Citation
Kotha SB, Alabdulaali RA, Dahy WT, Alkhaibari YR, Albaraki ASM, Alghanim AF. The Influence of Oral Health Knowledge on Parental Practices among the Saudi Parents of Children Aged 2-6 Years in Riyadh City, Saudi Arabia. J Int Soc Prev Community Dent. 2018 Nov-Dec;8(6):565-571. doi: 10.4103/jispcd.JISPCD_341_18. Epub 2018 Nov 29.
Results Reference
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PubMed Identifier
28879241
Citation
Marshman Z, Ahern SM, McEachan RRC, Rogers HJ, Gray-Burrows KA, Day PF. Parents' Experiences of Toothbrushing with Children: A Qualitative Study. JDR Clin Trans Res. 2016 Jul;1(2):122-130. doi: 10.1177/2380084416647727. Epub 2016 Apr 26.
Results Reference
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PubMed Identifier
22629353
Citation
Harnacke D, Mitter S, Lehner M, Munzert J, Deinzer R. Improving oral hygiene skills by computer-based training: a randomized controlled comparison of the modified Bass and the Fones techniques. PLoS One. 2012;7(5):e37072. doi: 10.1371/journal.pone.0037072. Epub 2012 May 21.
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Credé M, Phillips LA. A meta-analytic review of the Motivated Strategies for Learning Questionnaire. Learning and individual differences 21(4): 337-46, 2011.
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PubMed Identifier
28592239
Citation
Pan N, Cai L, Xu C, Guan H, Jin Y. Oral health knowledge, behaviors and parental practices among rural-urban migrant children in Guangzhou: a follow-up study. BMC Oral Health. 2017 Jun 7;17(1):97. doi: 10.1186/s12903-017-0385-2.
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Soltani R, Ali Eslami A, Mahaki B, Alipoor M, Sharifirad G. Do maternal oral health-related self-efficacy and knowledge influence oral hygiene behavior of their children?. International Journal of Pediatrics 4(7): 2035-42, 2016.
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Citation
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Wilson M, Morgan M. A survey of children's toothbrushing habits in Wales: Are parents following the guidelines?. Journal of Health Visiting 4(2):95-9, 2016.
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Citation
Poutanen R, Lahti S, Seppa L, Tolvanen M, Hausen H. Oral health-related knowledge, attitudes, behavior, and family characteristics among Finnish schoolchildren with and without active initial caries lesions. Acta Odontol Scand. 2007 Apr;65(2):87-96. doi: 10.1080/00016350601058077.
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D'Cruz AM, Aradhya S. Impact of oral health education on oral hygiene knowledge, practices, plaque control and gingival health of 13- to 15-year-old school children in Bangalore city. Int J Dent Hyg. 2013 May;11(2):126-33. doi: 10.1111/j.1601-5037.2012.00563.x. Epub 2012 Jun 30.
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Links:
URL
https://gih.instructure.com/files/2040/download?download_frd=1
Description
Official questionnaire about intrinsic motivation which will be used for measure motivation for learning oral hygiene.
URL
http://www.designedtosmile.org/wp-content/uploads/2017/06/2013-D2S-Part-II-Evaluation-Interim-Report-II-December-2013.pdf
Description
Questionnaire about oral health-related knowledge, attitudes, belief, and behavior we will get information about the knowledge of children and parents about oral health.

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Learning Brushing Using Game Elements in Mobile Phones Apps

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