Oral HygieneGAMIFYBRUSHNCT03935009
Learning Brushing Using Game Elements in Mobile Phones Apps
A study testing Manual toothbrush Curaprox 5460 ultra soft, Electric toothbrush Play Smart Brush N°1 and Electric toothbrush Play Smart Brush N°2 in people with Oral Hygiene and Dental Plaque, run by University Maribor at 2 sites in Slovenia.
Trial summary
The study aims to compare the efficacy of using gamification for oral hygiene in children at home environment. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Oral Hygiene, Dental Plaque, Children, Only
- What is being tested?
- Manual toothbrush Curaprox 5460 ultra soft, Electric toothbrush Play Smart Brush N°1 and Electric toothbrush Play Smart Brush N°2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesSlovenia
- Study dates
- May 2019to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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;
Who cannot join
- Children with the fixed orthodontic appliance;
- Children above 14 years;
Trial locations and contacts
2 sites in 1 country.
Slovenia2 sites, 2 recruiting
- Recruiting
University Maribor
Maribor, 2000
Nino Fijacko, +38623004764, nino.fijacko@um.si
Gregor Stiglic, +38623004731, gregor.stiglic@um.si
- Recruiting
University of Maribor Faculty of health sciences
Maribor, 2000
Nino Fijacko, +38623004764, nino.fijacko@um.si
Gregor Stiglic, +38623004731, gregor.stiglic@um.si
About this study
Official title: 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.
Read the 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.
- Conditions
- Oral Hygiene, Dental Plaque, Children, Only, Dental Devices, Home Care, Motivation, Learning
- Being tested
- Manual toothbrush Curaprox 5460 ultra soft, Electric toothbrush Play Smart Brush N°1, Electric toothbrush Play Smart Brush N°2
- Keywords
- Oral hygiene, Dental Plaque, Brushing, Flossing, Gamification, Game elements, Motivation, Education, Children, Parents
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual toothbrush Curaprox 5460 ultra softBehavioural
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°1Behavioural
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°2Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Manual toothbrush Curaprox 5460 ultra soft; Behavioral: 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. Receives: Behavioral: Manual toothbrush Curaprox 5460 ultra soft; Behavioral: 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. Receives: Behavioral: Electric toothbrush Play Smart Brush N°1; Behavioral: Electric toothbrush Play Smart Brush N°2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six weeks after baseline
Secondary outcomes (2)
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.
Measured: 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.
Measured: Six weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study startMay 2019 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- Playbrush GmbH, Flegis d.o.o., Middle-sized public primary school Videm pri Ptuju
- Responsible party
- Principal investigator, Nino Fijačko, University Maribor
- Investigators
- Nino Fijacko, Study chair, University Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935009
- Sponsor's protocol ID
- UM2019
- Acronym
- GAMIFYBRUSH
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and all data will be part of the published article in the journal.
Publications
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.
PubMed 21612316Kotha 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.
PubMed 30596050Marshman 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.
PubMed 28879241Harnacke 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.
PubMed 22629353Credé 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.
PubMed 28592239Soltani 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.
PubMed 24117628Wilson 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 SIMPLIFIED ORAL HYGIENE INDEX. J Am Dent Assoc. 1964 Jan;68:7-13. doi: 10.14219/jada.archive.1964.0034. No abstract available.
PubMed 14076341Poutanen 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.
PubMed 17453426McAuley 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.
PubMed 2489825D'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.
PubMed 22747831de 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.
PubMed 23157162Eden 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.
PubMed 30577724
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Oral Hygiene Using Gamification: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT03935009
- Acronym / sponsor ID
- GAMIFYBRUSH / UM2019
- Conditions
- Oral Hygiene, Dental Plaque, Children, Only, Dental Devices, Home Care, Motivation, Learning
- Keywords
- Oral hygiene, Dental Plaque, Brushing, Flossing, Gamification, Game elements, Motivation, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University MariborUniversity, hospital or other
- Collaborators
- Playbrush GmbH, Flegis d.o.o., Middle-sized public primary school Videm pri Ptuju
- Study start
- May 2019 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual toothbrush with electric toothbrush N°1 | Active comparator | Behavioral: Manual toothbrush Curaprox 5460 ultra soft, Behavioral: Electric toothbrush Play Smart Brush N°1Participants 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. |
| Manual toothbrush with electric toothbrush N°2 | Active comparator | Behavioral: Manual toothbrush Curaprox 5460 ultra soft, Behavioral: Electric toothbrush Play Smart Brush N°2Participants 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. |
| Electric toothbrush N°1 with electric toothbrush N°2 | Active comparator | Behavioral: Electric toothbrush Play Smart Brush N°1, Behavioral: Electric toothbrush Play Smart Brush N°2Participants 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (2 listed)
- Children with the fixed orthodontic appliance;
- Children above 14 years;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual toothbrush Curaprox 5460 ultra softSoft 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. | Behavioural | Manual toothbrush with electric toothbrush N°1, Manual toothbrush with electric toothbrush N°2 |
| Electric toothbrush Play Smart Brush N°1Electric 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. | Behavioural | Electric toothbrush N°1 with electric toothbrush N°2, Manual toothbrush with electric toothbrush N°1 |
| Electric toothbrush Play Smart Brush N°2Electric 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. | Behavioural | Electric toothbrush N°1 with electric toothbrush N°2, Manual toothbrush with electric toothbrush N°2 |
Primary outcome
Control 1: Intrinsic motivation
Time frame: Baseline
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
Time frame: Baseline
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
Time frame: Two weeks after baseline
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
Time frame: Two weeks after baseline
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
Time frame: Six weeks after baseline
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
Time frame: Six weeks after baseline
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.
2 secondary outcomes
Oral hygiene knowledge of participants 1
Time frame: Baseline
Oral hygiene knowledge of participants 2
Time frame: Six weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Background: PubMed 21612316Acharya 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.
- Background: PubMed 30596050Kotha 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.
- Background: PubMed 28879241Marshman 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.
- Background: PubMed 22629353Harnacke 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.
- BackgroundCredé M, Phillips LA. A meta-analytic review of the Motivated Strategies for Learning Questionnaire. Learning and individual differences 21(4): 337-46, 2011.
- Background: PubMed 28592239Pan 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.
- BackgroundSoltani 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: PubMed 24117628Wilson 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.
- BackgroundWilson 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: PubMed 14076341GREENE 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.
- Background: PubMed 17453426Poutanen 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.
- Background: PubMed 2489825McAuley 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.
- Official questionnaire about intrinsic motivation which will be used for measure motivation for learning oral hygiene.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study protocol and all data will be part of the published article in the journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nino Fijacko study chair
University Maribor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual toothbrush Curaprox 5460 ultra soft, Electric toothbrush Play Smart Brush N°1 and Electric toothbrush Play Smart Brush N°2 in people with Oral Hygiene and Dental Plaque, run by University Maribor at 2 sites in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nino Fijacko (+38623004764, nino.fijacko@um.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control 1: Intrinsic motivation (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935009, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.