NCT03935009

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

April 16, 2019

Last Update Submit

April 29, 2019

Conditions

Keywords

Oral hygieneDental PlaqueBrushingFlossingGamificationGame elementsMotivationEducationChildrenParents

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (2)

  • Oral hygiene knowledge of participants 1

    Baseline

  • Oral hygiene knowledge of participants 2

    Six weeks after baseline

Other Outcomes (2)

  • Indirect influence on oral hygiene of participants 1

    Baseline

  • Indirect influence on oral hygiene of participants 2

    Six weeks after baseline

Study Arms (3)

Manual toothbrush with electric toothbrush N°1

ACTIVE COMPARATOR

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 softBehavioral: Electric toothbrush Play Smart Brush N°1

Manual toothbrush with electric toothbrush N°2

ACTIVE COMPARATOR

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 softBehavioral: Electric toothbrush Play Smart Brush N°2

Electric toothbrush N°1 with electric toothbrush N°2

ACTIVE COMPARATOR

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°1Behavioral: Electric toothbrush Play Smart Brush N°2

Interventions

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.

Manual toothbrush with electric toothbrush N°1Manual toothbrush with electric toothbrush N°2

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 N°1 with electric toothbrush N°2Manual toothbrush with electric toothbrush N°1

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°2Manual toothbrush with electric toothbrush N°2

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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;

You may not qualify if:

  • Children with the fixed orthodontic appliance;
  • Children above 14 years;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Maribor

Maribor, 2000, Slovenia

RECRUITING

University of Maribor Faculty of health sciences

Maribor, 2000, Slovenia

RECRUITING

Related 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.

    PMID: 21612316BACKGROUND
  • 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.

    PMID: 30596050BACKGROUND
  • 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.

    PMID: 28879241BACKGROUND
  • 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.

    PMID: 22629353BACKGROUND
  • Credé M, Phillips LA. A meta-analytic review of the Motivated Strategies for Learning Questionnaire. Learning and individual differences 21(4): 337-46, 2011.

    BACKGROUND
  • 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.

    PMID: 28592239BACKGROUND
  • 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.

    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.

    PMID: 24117628BACKGROUND
  • 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.

    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.

    PMID: 14076341BACKGROUND
  • 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.

    PMID: 17453426BACKGROUND
  • 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.

    PMID: 2489825BACKGROUND
  • 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.

    PMID: 22747831BACKGROUND
  • 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.

    PMID: 23157162BACKGROUND
  • 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.

    PMID: 30577724BACKGROUND
  • 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.

    BACKGROUND

Related Links

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Nino Fijacko

    University Maribor

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching assistant

Study Record Dates

First Submitted

April 16, 2019

First Posted

May 2, 2019

Study Start

May 1, 2019

Primary Completion

July 1, 2019

Study Completion

December 1, 2019

Last Updated

May 2, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will share

The study protocol and all data will be part of the published article in the journal.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD will be available after publishing an article in the journal.
Access Criteria
No special criteria.
More information

Locations