Learning Brushing Using Game Elements in Mobile Phones Apps

Dental Plaque Clinical Trial

— GAMIFYBRUSH  

Official title:

Learning Oral Hygiene Using Gamification: a Randomized Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03935009
• Other study ID #: UM2019
• Status: Recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: University Maribor
• Contact: Nino Fijacko
• Phone: +38623004764
• Email: nino.fijacko[@]um.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 14 Years

Eligibility

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;

Related Conditions & MeSH terms

• Children, Only
• Dental Devices, Home Care
• Dental Plaque
• Learning
• Motivation
• Oral Hygiene

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Slovenia	University Maribor	Maribor
Slovenia	University of Maribor Faculty of health sciences	Maribor

Sponsors (4)

Lead Sponsor	Collaborator
University Maribor	Flegis d.o.o., Middle-sized public primary school Videm pri Ptuju, Playbrush GmbH

Country where clinical trial is conducted

Slovenia, 

References & Publications (16)

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. — View Citation

Credé M, Phillips LA. A meta-analytic review of the Motivated Strategies for Learning Questionnaire. Learning and individual differences 21(4): 337-46, 2011.

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. — View Citation

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. — View Citation

Eden E, Akyildiz M, Sönmez 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. — View Citation

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.

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. — View 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. — View Citation

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.

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. — View Citation

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. — View 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. — View Citation

Poutanen R, Lahti S, Seppä 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. — View Citation

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. — View Citation

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.

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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

External 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.