Trial Outcomes & Findings for BEhavioral EConomics for Oral Health iNnovation Trial (NCT NCT03576326)
NCT ID: NCT03576326
Last Updated: 2025-09-19
Results Overview
Mean of the number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. (A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
244 participants
Primary outcome timeframe
Baseline visit through the Month 6 visit
Results posted on
2025-09-19
Participant Flow
Child-Parent Dyads were recruited and Dyad is the unit of analysis Protocol Enrollment number is the number of Dyads recruited, enrolled, and analyzed; total number of participants who Started the study is the number of Individual participants in the study (i.e., 2x number of dyads).
Participant milestones
| Measure |
Incentive Drawing: Children
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
Incentive Drawing: Parents
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
Control - Delayed Incentive: Children
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Control - Delayed Incentive: Parents
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
122
|
122
|
122
|
122
|
|
Overall Study
3 Months
|
107
|
107
|
106
|
106
|
|
Overall Study
6 Months
|
101
|
101
|
103
|
103
|
|
Overall Study
COMPLETED
|
92
|
92
|
94
|
94
|
|
Overall Study
NOT COMPLETED
|
30
|
30
|
28
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BEhavioral EConomics for Oral Health iNnovation Trial
Baseline characteristics by cohort
| Measure |
Incentive Drawing: Children
n=122 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
Incentive Drawing: Parents
n=122 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
Control - Delayed Incentive: Children
n=122 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Control - Delayed Incentive: Parents
n=122 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Total
n=488 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
122 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
245 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
120 Participants
n=4 Participants
|
242 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
1.6 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
1.6 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
32.7 years
STANDARD_DEVIATION 6.7 • n=4 Participants
|
17.1 years
STANDARD_DEVIATION 16.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
346 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
142 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
106 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
416 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
71 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
77 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
83 Participants
n=4 Participants
|
321 Participants
n=21 Participants
|
|
Study Site
Location A
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Study Site
Location B
|
87 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
354 Participants
n=21 Participants
|
|
Study Site
Location C
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline visit through the Month 6 visitPopulation: any post-baseline evaluable data from 0 to 6 months
Mean of the number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth. (A Bluetooth-recorded toothbrushing episode qualifies if it lasts at least one minute within one of 14 half-day windows in the week.)
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=116 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=116 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Toothbrushing Performance
|
4.6 qualifying half-day episodes per week
Standard Deviation 2.8
|
5.6 qualifying half-day episodes per week
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Baseline visit through the Month 1 visitPopulation: any post-baseline evaluable data from 0 to 1 months
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=111 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=109 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Short-term (Immediate) Toothbrushing Performance
|
5.4 qualifying half-day episodes per week
Standard Deviation 3.2
|
6.2 qualifying half-day episodes per week
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline visit through the Month 3 visitPopulation: any post-baseline evaluable data from 0 to 3 months
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=113 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=112 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Mid-term Toothbrushing Performance
|
4.9 qualifying half-day episodes per week
Standard Deviation 3.0
|
5.8 qualifying half-day episodes per week
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Month 6 visit through the Month 12 visitPopulation: any post-baseline evaluable data from 6 to 12 months
Mean number of qualifying half-day episodes per week in which a parent/caregiver brushes a child's teeth.
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=97 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=98 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Toothbrushing Performance Sustainability
|
4.3 qualifying half-day episodes per week
Standard Deviation 2.6
|
4.8 qualifying half-day episodes per week
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: Month 6 visitPopulation: some participants did not complete the self-efficacy instrument at 6 months
Caregiver (parent) oral health self-efficacy items (total score ranges 6-30 with higher score indicating more self-efficacy; 6 items each on 1-5 ordinal scale, Albino et al.; Finlayson et al.)
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=103 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=101 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Self-efficacy Scale
|
26.4 score on a scale
Standard Deviation 2.6
|
25.9 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Month 6 visit and Month 12 visitPopulation: Not all randomized children were available for evaluation at Month 6 and Month 12.
Debris Index of the Simplified Oral Hygiene Index for Maxillary Incisors (OHI-MIS) to measure child's plaque on primary maxillary incisor facial (labial) tooth surfaces (mean of 4 ordinal scores each with values ranging from no plaque (1) - which is best - to abundant plaque (4) - which is worst)
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=90 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=86 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Modified Simplified Oral Hygiene Index
Month 6
|
2.2 units on a scale
Standard Deviation 0.6
|
2.1 units on a scale
Standard Deviation 0.5
|
|
Modified Simplified Oral Hygiene Index
Month 12
|
2.2 units on a scale
Standard Deviation 0.6
|
2.1 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: From Baseline to Month 6 visit and From Month 6 visit to Month 12 visitPopulation: Data were only available for participants who brought toothpaste tube back on follow-up visits at Month 6 and Month 12.
Change in child's toothpaste pump weight (grams) from each distribution visit (6 months prior). Negative mean values are a decrease from an earlier time to a subsequent time.
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=67 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=66 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Change From Baseline in Toothpaste Weight
Baseline to Month 6
|
-44.9 grams
Standard Deviation 25.4
|
-40.9 grams
Standard Deviation 27.7
|
|
Change From Baseline in Toothpaste Weight
Month 6 to Month 12
|
-51.4 grams
Standard Deviation 32.5
|
-48.0 grams
Standard Deviation 32.3
|
SECONDARY outcome
Timeframe: Month 6 visit and Month 12 visitPopulation: Not all randomized children were available for evaluation at Month 6 and Month 12.
Number and percent of children with untreated caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's untreated caries status (dt\>0)
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=94 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=90 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Untreated Caries
Month 6
|
14 Participants
|
13 Participants
|
|
Untreated Caries
Month 12
|
9 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Month 6 visit and Month 12 visitPopulation: Not all randomized children were available for evaluation at Month 6 and Month 12.
Number and percent of children with any history of caries using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's caries experience status (dmft\>0)
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=94 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=90 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Caries Experience
Month 6
|
16 Participants
|
17 Participants
|
|
Caries Experience
Month 12
|
12 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Month 6 visit and Month 12 visitPopulation: Not all randomized children were available for evaluation at Month 6 and Month 12.
Number and percent of children with severe caries experience using Association of State and Territorial Dental Directors Basic Screening Survey (ASTDD BSS) binary (yes/no) measure of child's severe caries experience status (dmft\>=4)
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=94 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=90 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Severe Caries
Month 6
|
3 Participants
|
5 Participants
|
|
Severe Caries
Month 12
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Month 12 visitPopulation: Data was not systematically recorded in the Early Head Start (EHS) ChildPlus database for individual child participants. EHS reports total number of visits per month but does not record that info for individuals in the EHS ChildPlus database.
Number and percent of children with a dental visit in the past 12 months, obtained through Early Head Start ChildPlus database which records child's binary annual dental visit (yes/no) and other required health screenings
Outcome measures
| Measure |
Control - Delayed Incentive: Parents
n=8 Participants
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Incentive Drawing: Parents
n=6 Participants
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
|---|---|---|
|
Past Year Dental Visit
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6 Participants
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5 Participants
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Adverse Events
Incentive Drawing: Children
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Incentive Drawing: Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Delayed Incentive: Children
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control - Delayed Incentive: Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Incentive Drawing: Children
n=122 participants at risk
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
Incentive Drawing: Parents
Eligible to earn a weekly drawing entry with different winning probabilities during the 6-month incentive intervention period. Possible winnings depend on toothbrushing performance: low adherence threshold (brushing child's teeth once per day for 7 days in a week) will have an 18% chance of winning $25 and a 1% chance of winning $50 (expected $5 payout); high adherence threshold (brushing twice per day for 14 days in a week) will have a 34% chance of winning $25 and a 3% chance of winning $50 (expected $10 payout).
Drawing Incentive: The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
|
Control - Delayed Incentive: Children
n=122 participants at risk
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
Control - Delayed Incentive: Parents
No rewards during the first 12 months, but information on toothbrushing performance. After the Month 12 follow-up visit, may opt to participate in a delayed 6-month open label extension to earn the same monetary rewards the intervention group could earn Baseline through Month 6. Not a formal part of this trial, but rather a necessary condition to assure all participating parents/caregivers have the chance to earn the same monetary incentives.
|
|---|---|---|---|---|
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Injury, poisoning and procedural complications
Tooth fracture
|
1.6%
2/122 • Number of events 3 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
—
0/0 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
2.5%
3/122 • Number of events 3 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
—
0/0 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
|
Infections and infestations
Dental infection/abscess
|
0.82%
1/122 • Number of events 1 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
—
0/0 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
0.82%
1/122 • Number of events 1 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
—
0/0 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
|
General disorders
Dental crown
|
0.00%
0/122 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
—
0/0 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
0.82%
1/122 • Number of events 1 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
—
0/0 • 2 years
Adverse events were observed for child participants only; parents were not monitored/assessed any of their own adverse events
|
Additional Information
Dr. Stuart Gansky
University of California, San Francisco
Phone: 415-502-8094
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place