CariesAOTSMNCT02027597
Improving Oral Health With Serious Games
A study testing Attack of the S. Mutans, Follow-up and SnowWorld in people with Caries and Tooth Decay, run by University of Washington at 1 site in United States.
Trial summary
This study investigated if computer games can be effective at changing the way children take care of their teeth. We a museum exhibit with 3D virtual reality games called "Attack of the S. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Tooth Decay, Cavities
- What is being tested?
- Attack of the S. Mutans, Follow-up and SnowWorld
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2011
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For participation in the study, enrollment criteria are as follows: 1) a dentist's diagnosis of tooth decay, or restorative dental work in the previous year; and 2) Parents or guardians provide usable baseline data, including contact information for follow-up questionnaires.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Firsthand Technology Inc.
Seattle, Washington, 98112
About this study
This study investigated if computer games can be effective at changing the way children take care of their teeth. We a museum exhibit with 3D virtual reality games called "Attack of the S. Mutans!" Our hypothesis was that children who played the games and visited the exhibit would show improved attitudes about oral health, which would translate into improved brushing and self-care habits.
In this randomized controlled study with school children aged 8-12, we compared the outcomes for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on classroom presentation about virtual reality being used for healthcare; Group 3) Received no-treatment.
- Conditions
- Caries, Tooth Decay, Cavities, Gingivitis
- Being tested
- Attack of the S. Mutans, Follow-up, SnowWorld
- Keywords
- video games, oral health, social cognitive theory, behavior change, randomized trial, growth modeling, minority, gender
- Medical subject headings
- Dental Caries, Gingivitis, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attack of the S. MutansOther
Also called AOTSM
A research assistant led groups of students through the Attack of the S. Mutans exhibit. All participants played all the games and viewed all the graphical content of the exhibit.
Follow-upOther
This group experienced the Attack of the S. Mutans! exhibit and 3 doses of follow-up booster content at a web site.
SnowWorldOther
SnowWorld is a 3D first-person-shooter game developed by Firsthand Technology. In SnowWorld, the player shoots snowballs at penguins, polar bears, and other features of a frozen landscape. The game is designed to help burn victims cope with pain, and has no oral health messages.
| Study group | Role | What they receive |
|---|---|---|
| Video Game Treatment | Experimental | This group received the AOTSM game experience followed by additional oral health information. They did not receive any follow-up treatment after the exhibit. Receives: Other: Attack of the S. Mutans |
| Control | Active comparator | Instead of playing Attack of the S. Mutans!, children in the control group attended a 90 minute classroom session about virtual reality applications for relieving pain and for therapy. This content was unrelated to oral health. Receives: Other: SnowWorld |
| Video Game Treatment Plus Follow-Up | Experimental | Children assigned to the Treatment-Plus conditions not only had the Attack of the S. Mutans video game experience, but also gained access to an educational website that reinforced the exhibit's teachings two months later. These students received a special login and password in the mail and were instructed to visit the site before completing their next questionnaire. Receives: Other: Attack of the S. Mutans; Other: Follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy
Follow-up surveys were conducted at 3 points after the intervention for all groups. The survey included questions about the children's attitudes (self-efficacy) toward oral health and taking care of their teeth. Surveys were paper-pencil self-reports from both parents and children. Items were drawn from Morowatisharifabad and Shirazi, (2007) and adapted for ease of understanding for English speaking children.
Measured: 8 months post treatment
Secondary outcomes (1)
Self-care behavior
Separate surveys of children and their parents were conducted at 3 points after the intervention all groups. The survey included questions about how often and how well the children took care of their teeth.
Measured: 8 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startOct 2008
- Primary completionDec 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Participant
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Jacqueline E. Pickrell, University of Washington
- Investigators
- Howard A Rose, M.Ed., Principal investigator, Firsthand TechnologyAri J Hollander, MSE, Principal investigator, Firsthand Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027597
- Sponsor's protocol ID
- 35095-EB
- Other IDs
- 5R44DE019043-02
- Acronym
- AOTSM
- Status last verified
- Jan 2014
- First submitted
- 2 Jan 2014
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Oral Health With Serious Games
- ClinicalTrials.gov ID
- NCT02027597
- Acronym / sponsor ID
- AOTSM / 35095-EB
- Conditions
- Caries, Tooth Decay, Cavities, Gingivitis
- Keywords
- video games, oral health, social cognitive theory, behavior change, randomized trial, growth modeling, minority, gender
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR), National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Oct 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Jan 2014 (estimated)
- 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.
This study investigated if computer games can be effective at changing the way children take care of their teeth. We a museum exhibit with 3D virtual reality games called "Attack of the S. Mutans!" Our hypothesis was that children who played the games and visited the exhibit would show improved attitudes about oral health, which would translate into improved brushing and self-care habits.
In this randomized controlled study with school children aged 8-12, we compared the outcomes for three groups: Group 1) Visited Attack of the S. Mutans!; Group 2) Experienced a hands-on classroom presentation about virtual reality being used for healthcare; Group 3) Received no-treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video Game Treatment | Experimental | Other: Attack of the S. MutansThis group received the AOTSM game experience followed by additional oral health information. They did not receive any follow-up treatment after the exhibit. |
| Control | Active comparator | Other: SnowWorldInstead of playing Attack of the S. Mutans!, children in the control group attended a 90 minute classroom session about virtual reality applications for relieving pain and for therapy. This content was unrelated to oral health. |
| Video Game Treatment Plus Follow-Up | Experimental | Other: Attack of the S. Mutans, Other: Follow-upChildren assigned to the Treatment-Plus conditions not only had the Attack of the S. Mutans video game experience, but also gained access to an educational website that reinforced the exhibit's teachings two months later. These students received a special login and password in the mail and were instructed to visit the site before completing their next questionnaire. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- For participation in the study, enrollment criteria are as follows: 1) a dentist's diagnosis of tooth decay, or restorative dental work in the previous year; and 2) Parents or guardians provide usable baseline data, including contact information for follow-up questionnaires.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Attack of the S. MutansAlso: AOTSMA research assistant led groups of students through the Attack of the S. Mutans exhibit. All participants played all the games and viewed all the graphical content of the exhibit. | Other | Video Game Treatment, Video Game Treatment Plus Follow-Up |
| Follow-upThis group experienced the Attack of the S. Mutans! exhibit and 3 doses of follow-up booster content at a web site. | Other | Video Game Treatment Plus Follow-Up |
| SnowWorldSnowWorld is a 3D first-person-shooter game developed by Firsthand Technology. In SnowWorld, the player shoots snowballs at penguins, polar bears, and other features of a frozen landscape. The game is designed to help burn victims cope with pain, and has no oral health messages. | Other | Control |
Primary outcome
Self-Efficacy
Time frame: 8 months post treatment
Follow-up surveys were conducted at 3 points after the intervention for all groups. The survey included questions about the children's attitudes (self-efficacy) toward oral health and taking care of their teeth. Surveys were paper-pencil self-reports from both parents and children. Items were drawn from Morowatisharifabad and Shirazi, (2007) and adapted for ease of understanding for English speaking children.
1 secondary outcome
Self-care behavior
Time frame: 8 months post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Web site for Firsthand Technology, creators of Attack of the S. Mutans!Link provided by the sponsor.
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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.
Howard A Rose, M.Ed. principal investigator
Firsthand Technology
Ari J Hollander, MSE principal investigator
Firsthand Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attack of the S. Mutans, Follow-up and SnowWorld in people with Caries and Tooth Decay, run by University of Washington at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy (time frame: 8 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2014.