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

Learning Oral Hygiene Using Gamification: a Randomized Clinical Study

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

Study Overview

• Status: Unknown
• Conditions: Oral Hygiene; Dental Plaque; Motivation; Children, Only; Learning; Dental Devices, Home Care
• 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

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nino Fijacko; Phone Number: +38623004764; Email: nino.fijacko@um.si
• Study Contact Backup: Name: Gregor Stiglic; Phone Number: +38623004731; Email: gregor.stiglic@um.si

Study Locations

• Slovenia
  • Maribor, Slovenia, 2000
    • Recruiting
    • University Maribor
    • Contact: Nino Fijacko; Phone Number: +38623004764; Email: nino.fijacko@um.si
    • Contact: Gregor Stiglic; Phone Number: +38623004731; Email: gregor.stiglic@um.si
  • Maribor, Slovenia, 2000
    • Recruiting
    • University of Maribor Faculty of health sciences
    • Contact: Nino Fijacko; Phone Number: +38623004764; Email: nino.fijacko@um.si
    • Contact: Gregor Stiglic; Phone Number: +38623004731; Email: gregor.stiglic@um.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Two weeks after baseline
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.	Two weeks after baseline
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.	Six weeks after baseline
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.	Six weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Six weeks after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indirect influence on oral hygiene of participants 1	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.	Baseline
Indirect influence on oral hygiene of participants 2	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.	Six weeks after baseline

Collaborators and Investigators

• Sponsor: University Maribor
• Collaborators: Playbrush GmbH; Flegis d.o.o.; Middle-sized public primary school Videm pri Ptuju
• Investigators: Study Chair: Nino Fijacko, University Maribor

Publications and helpful links

General Publications

• McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport. 1989 Mar;60(1):48-58. doi: 10.1080/02701367.1989.10607413.
• 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.
• 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.
• 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.
• 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.
• Credé M, Phillips LA. A meta-analytic review of the Motivated Strategies for Learning Questionnaire. Learning and individual differences 21(4): 337-46, 2011.
• 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.
• 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.
• Wilson A, Brega AG, Batliner TS, Henderson W, Campagna EJ, Fehringer K, Gallegos J, Daniels D, Albino J. Assessment of parental oral health knowledge and behaviors among American Indians of a Northern Plains tribe. J Public Health Dent. 2014 Spring;74(2):159-67. doi: 10.1111/jphd.12040. Epub 2013 Oct 9.
• 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.
• Greene JC, Vermillion JR. The oral hygiene index: a method for classifying oral hygiene status. The Journal of the American Dental Association 61(2): 172-9, 1960.
• 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.
• 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.
• de Silva-Sanigorski A, Ashbolt R, Green J, Calache H, Keith B, Riggs E, Waters E. Parental self-efficacy and oral health-related knowledge are associated with parent and child oral health behaviors and self-reported oral health status. Community Dent Oral Epidemiol. 2013 Aug;41(4):345-52. doi: 10.1111/cdoe.12019. Epub 2012 Nov 17.
• Eden E, Akyildiz M, Sonmez I. Comparison of Two School-Based Oral Health Education Programs in 9-Year-Old Children. Int Q Community Health Educ. 2019 Apr;39(3):189-196. doi: 10.1177/0272684X18819980. Epub 2018 Dec 21.
• Kumar SR, Narayanan MA, Jayanthi D. Comparison of oral hygiene status before and after health education among 12-18-year-old patients. Journal of Indian Association of Public Health Dentistry 14(2):121, 2016.

Helpful Links

• Official questionnaire about intrinsic motivation which will be used for measure motivation for learning oral hygiene.
• Questionnaire about oral health-related knowledge, attitudes, belief, and behavior we will get information about the knowledge of children and parents about oral health.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2019
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 2, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Children; Motivation; Oral hygiene; Parents; Education; Dental Plaque; Brushing; Flossing; Gamification; Game elements
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits; Dental Plaque
• Other Study ID Numbers: UM2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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 Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No