Learning Brushing Using Game Elements in Mobile Phones Apps

NCT ID: NCT03935009

Last Updated: 2019-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Manual toothbrush Curaprox 5460 ultra soft

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Manual toothbrush Curaprox 5460 ultra soft

Intervention Type BEHAVIORAL

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°2

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Electric toothbrush Play Smart Brush N°1

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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;
Minimum Eligible Age

10 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Playbrush GmbH

UNKNOWN

Sponsor Role collaborator

Flegis d.o.o.

UNKNOWN

Sponsor Role collaborator

Middle-sized public primary school Videm pri Ptuju

UNKNOWN

Sponsor Role collaborator

University Maribor

OTHER

Sponsor Role lead

Responsible Party

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Nino Fijačko

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nino Fijacko

Role: STUDY_CHAIR

University Maribor

Locations

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University Maribor

Maribor, , Slovenia

Site Status RECRUITING

University of Maribor Faculty of health sciences

Maribor, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Nino Fijacko

Role: CONTACT

+38623004764

Gregor Stiglic

Role: CONTACT

+38623004731

Facility Contacts

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Nino Fijacko

Role: primary

+38623004764

Gregor Stiglic

Role: backup

+38623004731

Nino Fijacko

Role: primary

+38623004764

Gregor Stiglic

Role: backup

+38623004731

References

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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.

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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.

Reference Type BACKGROUND

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Reference Type BACKGROUND
PMID: 28592239 (View on PubMed)

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.

Reference Type BACKGROUND

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.

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PMID: 24117628 (View on PubMed)

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.

Reference Type BACKGROUND

GREENE JC, VERMILLION JR. THE SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.

Reference Type BACKGROUND
PMID: 14076341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17453426 (View on PubMed)

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.

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PMID: 2489825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22747831 (View on PubMed)

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.

Reference Type BACKGROUND
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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.

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Reference Type BACKGROUND

Related Links

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https://gih.instructure.com/files/2040/download?download_frd=1

Official questionnaire about intrinsic motivation which will be used for measure motivation for learning oral hygiene.

Other Identifiers

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UM2019

Identifier Type: -

Identifier Source: org_study_id

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