GingivitisNCT02160418
Incentives for Daily Tooth Brushing to Reduce Gingivitis
A study testing Financial Incentives, Cognitive Incentives and Financial and Cognitive Incentives in people with Gingivitis, run by University of Pennsylvania at 1 site in United States.
Trial summary
In this randomized controlled study, the investigators compare two classes of behavioral approaches to change habits and health outcomes with an application to dental health: cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid to correctly answer health-related quizzes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Financial Incentives, Cognitive Incentives and Financial and Cognitive Incentives
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Dec 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female older than 18 years, with at least 10 teeth present.
Who cannot join
- Pregnancy, uncontrolled diabetes, systemic antibiotics taken within the previous 2 months, need for referral for periodontal treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
In this randomized controlled study, the investigators compare two classes of behavioral approaches to change habits and health outcomes with an application to dental health: cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid to correctly answer health-related quizzes. Under behavioral incentives subjects earn money for making healthy choices. The investigators apply these incentives to toothbrushing, a daily health-related behavior critical to the prevention of dental caries and periodontal disease, two high-burden conditions among US adults.
- Conditions
- Gingivitis
- Being tested
- Financial Incentives, Cognitive Incentives, Financial and Cognitive Incentives
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesBehavioural
Cognitive IncentivesBehavioural
Financial and Cognitive IncentivesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 36 Participants will be sent a new toothbrush and will be asked to use it in place of their current brush. They also receive twice daily reminders via sms to brush their teeth. |
| Financial Incentives | Experimental | 36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. They will also be offered financial incentives twice a day to brush their teeth. Receives: Behavioral: Financial Incentives |
| Cognitive Incentives | Experimental | 36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. Twice a week, they will receive text messages (SMS) with a short quiz question related to oral hygiene behavior and oral health. Participants will receive a reward if they answer correctly via text message. Receives: Behavioral: Cognitive Incentives |
| Financial and Cognitive Incentives | Experimental | 36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. Twice daily they receive financial incentives to brush their teeth. Twice a week, they will receive text messages (SMS) with a short quiz question related to oral hygiene behavior and oral health. Participants will receive a reward if they answer correctly via text message. Receives: Behavioral: Financial and Cognitive Incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up Gingival Index
Measured: 6 months
Secondary outcomes (2)
Frequency and duration of toothbrushing
Measured: 3 months
End of treatment Gingival Index
Gingival Index at the end of behavioral incentives
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion14 Apr 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160418
- Sponsor's protocol ID
- 819853
- Status last verified
- Apr 2017
- First submitted
- 3 Jun 2014
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives for Daily Tooth Brushing to Reduce Gingivitis
- ClinicalTrials.gov ID
- NCT02160418
- Acronym / sponsor ID
- 819853
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 10 Jun 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.
In this randomized controlled study, the investigators compare two classes of behavioral approaches to change habits and health outcomes with an application to dental health: cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid to correctly answer health-related quizzes. Under behavioral incentives subjects earn money for making healthy choices. The investigators apply these incentives to toothbrushing, a daily health-related behavior critical to the prevention of dental caries and periodontal disease, two high-burden conditions among US adults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –36 Participants will be sent a new toothbrush and will be asked to use it in place of their current brush. They also receive twice daily reminders via sms to brush their teeth. |
| Financial Incentives | Experimental | Behavioral: Financial Incentives36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. They will also be offered financial incentives twice a day to brush their teeth. |
| Cognitive Incentives | Experimental | Behavioral: Cognitive Incentives36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. Twice a week, they will receive text messages (SMS) with a short quiz question related to oral hygiene behavior and oral health. Participants will receive a reward if they answer correctly via text message. |
| Financial and Cognitive Incentives | Experimental | Behavioral: Financial and Cognitive Incentives36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. Twice daily they receive financial incentives to brush their teeth. Twice a week, they will receive text messages (SMS) with a short quiz question related to oral hygiene behavior and oral health. Participants will receive a reward if they answer correctly via text message. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female older than 18 years, with at least 10 teeth present.
Key exclusion criteria (1 listed)
- Pregnancy, uncontrolled diabetes, systemic antibiotics taken within the previous 2 months, need for referral for periodontal treatment.
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 |
|---|---|---|
| Financial Incentives | Behavioural | Financial Incentives |
| Cognitive Incentives | Behavioural | Cognitive Incentives |
| Financial and Cognitive Incentives | Behavioural | Financial and Cognitive Incentives |
Primary outcome
Follow-up Gingival Index
Time frame: 6 months
2 secondary outcomes
Frequency and duration of toothbrushing
Time frame: 3 months
End of treatment Gingival Index
Time frame: 3 months
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 5 Apr 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives, Cognitive Incentives and Financial and Cognitive Incentives in people with Gingivitis, run by University of Pennsylvania 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 5 Apr 2018. 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?
Follow-up Gingival Index (time frame: 6 months). 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 5 Apr 2018.