An interventional study of OHT Parent targeted text messages and CWT Parent targeted text messages in Caries, Dental and Health Behavior, sponsored by Boston University. Completed at 1 site in United States. Open to participants aged 0 Months to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Boston University · Not applicable, Interventional, and Prevention
Among 193 studies in Dental Caries with a site in United States — 16 open to participants now, 19 under way, 3 of them phase 3. Dental Caries · United States.
Among the 193 studies in Dental Caries with a site in United States, this one is the 21st largest by enrollment of the 168 interventional ones that give a count, is one of 12 that started in 2018, is one of 110 with no phase, and was the 111th registered.
1,171 studies on the registry are indexed under Dental Caries; 209 are open to participants now.
Browse Dental Caries studies →16 of the 193 studies in Dental Caries with a site in United States are open now. Recruiting first, the newest first:
University of Michigan · Sites in United States
Ages 8–12
University of Michigan · Sites in United States
Ages 18–99
A.T. Still University of Health Sciences · Sites in United States
Ages 6–10
University of Pennsylvania · Sites in United States
Ages 5–13 · Healthy volunteers
University of Massachusetts, Worcester · Sites in United States
Ages 12 mo–45 yrs · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 86 Dental Caries studies recruiting now, 18 (21%) set no upper age limit and 66 (77%) stop at 75 or younger; 60 take children under 18; 53 take healthy volunteers.
This study: 0 Months to 7 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
193 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 19 · Phase 3 23 · Phase 4 4
First in 1996; this study’s year is marked. 12 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 754 is above the median of 60 across 967 interventional studies indexed under Dental Caries.
Median enrollment 60 across the 168 interventional studies, 264 across the 25 observational. Of the 166 that completed or were terminated, 68 (41%) have results posted.
This tab as a report to print or save as PDF → With an account.
44 of 193 have an industry lead sponsor. The 10 most frequent:
Boston University is the lead sponsor of 271 studies on the registry; 37 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Boston University has 2 studies filed under Dental Caries — fewer than ten, so there is no comparison to draw.
6 of the studies in Dental Caries with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07124533Phase 3Loma Linda UniversityEffectiveness of Toothpaste Tablets on Plaque, Gingival Health and Caries Experiences | 2026-12 |
| NCT06588725Vanderbilt University Medical CenterBrief Interventions to Improve Behavior Outcomes and Prevent Cavities | 2027-01 |
| NCT05756413University of IowaBirth to Three - Cavity Free | 2027-03-31 |
| NCT07648212University of MichiganArtificial Intelligence (AI) for Proximal Caries Detection and Its Impact on Treatment Threshold | 2027-05 |
| NCT06714929Virginia Commonwealth UniversityAdvancing Water Security: A Community Participatory School-Based Hydration Intervention | 2027-05-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 193 studies in Dental Caries with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a randomized clinical trial to test the efficacy of a parent-targeted text message-based intervention program on caries incidence and oral health behaviors (child and parent). Parents (n= 850) across all pediatric clinic sites (Boston Medical Center and Community Health Centers (CHCs); DotHouse CHC, South End Community Health Center, and Codman Square CHC) will be randomized to receive either text messages (TMs) regarding oral health or TMs regarding child wellness. The study will enroll English and Spanish speaking parents and their youngest child who is \< 7 years old, has at least one tooth showing, and attends the targeted pediatric clinic to receive primary care (n= 1700). Parents will complete self-report surveys at baseline, and 2, 4, 12, and 24-months after baseline; receive and respond to TM assessments during the 4-month intervention; and will also receive TMs during a 'booster' period of one month, which will occur 12-months post baseline. Parent's children will be assessed for caries by a clinical oral examination performed by licensed Clinical Examiners at baseline, 12-and-24-months post-baseline.
Inclusion Criteria: Caregiver and child must meet all of the following:
Exclusion Criteria: If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study
Participants in this arm will receive the OHT parent targeted text messages to reduce caries and improve oral health behaviors among low income families visiting community-based, urban pediatric clinics.
Other: OHT Parent targeted text messages
Participants in this arm will receive the CWT parent targeted text messages to improve child wellness (e.g., reading time, safety) among low income families visiting community-based, urban pediatric clinics.
Other: CWT Parent targeted text messages
For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.
For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.
Dental Caries Increment
Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
Time frame: 24-month time point (oral assessment)
Parent/Caregiver Confidence to Brush
9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)
Time frame: 4-month time point (survey)
Parent/Caregiver Motivation to Perform Oral Health Behaviors
A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)
Time frame: 4-month time point (survey)
Parent/Caregiver Outcome Expectations for Oral Health Behaviors
An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).
Time frame: 4-month time point (survey)
Self-efficacy to Perform Oral Health Behaviors
The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).
Time frame: 4-month time point (survey)
Dental Caries Increment (Surface Level)
Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
Time frame: 24-month time point (oral assessment)
Text Message Program Length Satisfaction
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
Time frame: 4-month time point (survey)
Parents' Perceived Impact of iSmile
Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).
Time frame: 4-month time point (survey)
Child Preventive Dental Visits
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.
Time frame: 4-month, 12-month, and 24-month time points (survey)
Fluoridated Toothpaste Use
One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.
Time frame: 4-month, 12-month, and 24-month time points (survey)
Perceived Impact of OHT Program on Parental Awareness
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.
Time frame: 24-month (survey)
Child Diet - Food Frequency
Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).
Time frame: 4-month, 12-month, and 24-month time points (survey)
Child Diet - Beverage Intake
Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).
Time frame: 4-month, 12-month, and 24-month time points (survey)
Child Tooth Brushing
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).
Time frame: 4-month, 12-month, and 24-month time points (survey)
Parent/Caregiver Tooth Brushing
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).
Time frame: 4-month, 12-month, and 24-month time points (survey)
Child Oral Health-related Quality of Life
The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).
Time frame: 4-month, 12-month, and 24-month time points (survey)
Satisfaction With Text Message Program Features
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).
Time frame: 4-month time point (survey)
Child Toothbrushing (Clinical Guidelines)
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into "child met clinical guidelines for brushing" (brushing at least two times per day, seven days of the week) vs not.
Time frame: 4-month, 12-month, and 24-month time points (survey)
Parents/Caregivers Toothbrushing (Clinical Guidelines)
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into "parent/caregiver participants met clinical guidelines for brushing" (brushed at least two times per day, seven days of the week) vs not.
Time frame: 4-month, 12-month, and 24-month time points (survey)
Diffusion of Text Messages (Satisfaction)
One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else
Time frame: 4-month time point (survey)
Text Message Program Star Rating
One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.
Time frame: 4-month time point (survey)
Text Message Program Quality
Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).
Time frame: 4-month time point (survey)
Type of Beverage Consumed Between Meals
Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.
Time frame: 4-month, 12-month, and 24-month time points (survey)
Challenge Week During the OHT Text Message Program
We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.
Time frame: 4-month time point
Dental Caries (Per Subject)
Number of primary teeth with new dental caries per child
Time frame: 24-Month (oral health assessment)
| Milestone | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Started | 377 | 377 |
| Number of parent/caregiver participants | 377 | 377 |
| Number of children participants | 377 | 377 |
| 4-month time point (survey) | 290 | 288 |
| 12-month time point (survey) | 282 | 290 |
| 12-month time point (oral exam) | 206 | 185 |
| 24-month time point (survey) | 272 | 270 |
| 24-month time point (oral exam) | 160 | 156 |
| Completed | 272 | 270 |
| Not completed | 105 | 107 |
| Withdrew: Lost to follow-up | 105 | 107 |
Surface level caries data in children was collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Dental Caries Increment | 162 | 161 |
9-item self-efficacy measure to assess parent/caregiver participant confidence in their ability to brush their child's teeth under different situations. (Finlayson measure; range 1 - 4; higher scores mean better outcome)
| score on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Parent/Caregiver Confidence to Brush | 2.9 ± 1.2 | 2.8 ± 1.2 |
A oral health motivation measure to assess parent/caregiver participants motivation to engage in recommended child oral health behaviors (score range 1 - 7; higher scores mean better outcome)
| score on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Parent/Caregiver Motivation to Perform Oral Health Behaviors | 6.2 ± 1.2 | 6.0 ± 1.3 |
An outcome expectancies measure to assess the degree to which parent/caregiver participants perceive that performing the oral health behaviors (e.g., brushing) will lead to the desired outcome (e.g., reduced dental caries) in their children (Stewart et al., 1997; range 1 - 4; higher scores mean better outcome).
| score on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Parent/Caregiver Outcome Expectations for Oral Health Behaviors | 3.69 ± 0.67 | 3.68 ± 0.60 |
The overall self-efficacy score represents how sure parent/caregiver participants are that they can engage in recommended behavior to take care of their children's teeth. (Based on Albino et al 2017; range 1 - 7; higher scores mean better outcome).
| score on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Self-efficacy to Perform Oral Health Behaviors | 6.3 ± 1.1 | 6.2 ± 1.2 |
Caries data in children participants collected by calibrated clinical examiners (blind to treatment condition), utilizing the OHDC Modified ICDAS methodology, will allow calculation of a surface of tooth-level caries increment (development of a new cavitated lesion or filled surface on a previously sound tooth surface).
| Tooth surfaces | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Dental Caries Increment (Surface Level) | 545 | 496 |
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| It was just about right | 193 | 172 |
| The program should last longer | 68 | 80 |
| The program should be shorter | 29 | 36 |
Three items adapted from the MARS to measure the perceived impact of the OHT text message program on parent/caregiver participants' attitudes towards their child's oral health (range 1 - 7; higher scores mean a better outcome).
| units on a scale | OHT Group |
|---|---|
| Making sure your child's teeth are brushed | 6.4 ± 1.3 |
| Decreasing the amount of sugar-sweetened beverages your child drinks | 5.9 ± 1.8 |
| Your feelings on taking your child to the dentist | 6.1 ± 1.6 |
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to assess the number of parent/caregiver participants who indicated that their child had a preventive dental visit.
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-month | 207 | 181 |
| 12-month | 180 | 157 |
| 4-month | 162 | 131 |
One item derived from the Basic Research Factors Questionnaire (BRFQ) to measure whether parent/caregiver participants use toothpaste containing fluoride when brushing their child's teeth.
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-month | 225 | 207 |
| 12-month | 229 | 215 |
| 4-month | 225 | 210 |
One item adapted from the Basic Research Factors Questionnaire (BRFQ) to measure parent/caregiver participants' (in the OHT arm) awareness of their child oral health.
| Participants | OHT Group |
|---|---|
| 1 - strongly disagree | 7 |
| 2 - | 3 |
| 3 - | 14 |
| 4 - | 33 |
| 5 - strongly agree | 207 |
| prefer not to answer | 8 |
Parent/caregiver participants completed a food frequency questionnaire (FFQ) to assess their child's diet. Food/beverages items in the FFQ are categorized into groups according to the degree to which they promote dental caries, and a weighted estimated cariogenicity score (ECS) is computed (minimum and maximum scores range 0 - 3.80; higher scores mean a worse outcome).
| score on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-month | 2.22 ± 0.31 | 2.27 ± 0.27 |
| 12-month | 2.23 ± 0.30 | 2.23 ± 0.24 |
| 4-month | 2.18 ± 0.28 | 2.22 ± 0.24 |
Parent/caregiver participants completed the beverage questionnaire for preschoolers (BEVQ-PS) to assess their child's beverage intake. For each beverage item, the frequency and the amount of consumption are computed as average fluid ounces per day, and a composite score is computed for sugar sweetened beverages (including 100% fruit juice) consumption and then categorized into higher consumption (vs lower).
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-month | 125 | 142 |
| 12-month | 145 | 131 |
| 4-month | 128 | 141 |
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week (range: 0 - 21; higher scores mean a better outcome).
| units on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-month | 12.0 ± 4.5 | 11.1 ± 5.1 |
| 12-month | 12.0 ± 4.4 | 11.6 ± 4.6 |
| 4-month | 12.9 ± 3.7 | 11.3 ± 5.0 |
An investigator-developed composite measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week (range: 0 - 21; higher scores mean a better outcome).
| units on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-month | 12.7 ± 3.8 | 12.3 ± 4.5 |
| 12-month | 12.7 ± 4.2 | 12.5 ± 4.4 |
| 4-month | 13.1 ± 3.8 | 12.4 ± 4.2 |
The Early Childhood Oral Health Impact Scale (ECOHIS) to measure parent/caregiver participants' perceptions of their child's oral health (range 0 - 16; higher scores mean a worse outcome).
| score on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-month | 1.03 ± 2.00 | 0.99 ± 1.80 |
| 12-month | 1.14 ± 2.03 | 0.96 ± 1.79 |
| 4-month | 0.65 ± 1.55 | 0.80 ± 1.76 |
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants' overall level of satisfaction with the text message program features (range 1 - 7; higher scores mean a better outcome).
| units on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Satisfaction With Text Message Program Features | 6.12 ± 1.27 | 6.04 ± 1.35 |
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed or supervised brushing their child's teeth during a week recoded into "child met clinical guidelines for brushing" (brushing at least two times per day, seven days of the week) vs not.
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-Month | 177 | 147 |
| 12-Month | 167 | 160 |
| 4-Month | 214 | 156 |
An investigator-developed measure derived from the number of days and number of times parent/caregiver participants brushed their teeth during a week recoded into "parent/caregiver participants met clinical guidelines for brushing" (brushed at least two times per day, seven days of the week) vs not.
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-Month | 188 | 175 |
| 12-Month | 195 | 183 |
| 4-Month | 208 | 191 |
One item adapted from the Mobile App Rating Scale (MARS) asks parent/caregiver participants whether they showed (or forwarded) text messages to anyone else
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Diffusion of Text Messages (Satisfaction) | 168 | 177 |
One item adapted from the Mobile App Rating Scale (MARS) asks participants to give a star rating of the text message program. The star rating score range 1 star to 5 stars; a higher number of stars mean a better outcome.
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 1 star | 1 | 3 |
| 2 stars | 12 | 7 |
| 3 stars | 43 | 50 |
| 4 stars | 89 | 88 |
| 5 stars | 145 | 139 |
| prefer not to answer | 0 | 1 |
Parent/caregiver participants responded to an investigator developed survey to measure several aspects of text messages quality (range 1 - 7; higher scores mean a better outcome).
| units on a scale | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Relevant to cultural background | 5.81 ± 1.65 | 5.56 ± 1.71 |
| Age appropriate for child | 6.0 ± 1.4 | 6.0 ± 1.4 |
| Content of TMs easy to understand | 6.5 ± 1.1 | 6.6 ± 1.0 |
| Easy to integrate into day/routine | 6.2 ± 1.2 | 6.2 ± 1.3 |
| Language appropriate | 6.5 ± 1.1 | 6.5 ± 1.1 |
| Relevant for you and your child | 6.2 ± 1.4 | 6.2 ± 1.4 |
Parent/caregiver participants are asked to indicate what beverage their child consumes most often between meals.
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 24-Month — 1. Cow's milk | 31 | 31 |
| 24-Month — 2. Juice or juice drinks | 63 | 77 |
| 24-Month — 3. Diet soda pop or other sugar free beverages | 1 | 0 |
| 24-Month — 4. Water | 164 | 149 |
| 24-Month — 5. Regular soda pop or other sugared beverages | 1 | 1 |
| 24-Month — 6. Flavored milk | 4 | 4 |
| 24-Month — 7. Other | 3 | 2 |
| 24-Month — Do not know | 2 | 1 |
| 24-Month — Prefer not to answer | 3 | 5 |
| 12-Month — 1. Cow's milk | 50 | 42 |
| 12-Month — 2. Juice or juice drinks | 63 | 70 |
| 12-Month — 3. Diet soda pop or other sugar free beverages | 1 | 0 |
| 12-Month — 4. Water | 154 | 166 |
| 12-Month — 5. Regular soda pop or other sugared beverages | 2 | 1 |
| 12-Month — 6. Flavored milk | 4 | 4 |
| 12-Month — 7. Other | 5 | 1 |
| 12-Month — Do not know | 0 | 1 |
| 12-Month — Prefer not to answer | 3 | 5 |
| 4-Month — 1. Cow's milk | 48 | 56 |
| 4-Month — 2. Juice or juice drinks | 63 | 69 |
| 4-Month — 3. Diet soda pop or other sugar free beverages | 1 | 4 |
| 4-Month — 4. Water | 159 | 147 |
| 4-Month — 5. Regular soda pop or other sugared beverages | 3 | 0 |
| 4-Month — 6. Flavored milk | 4 | 3 |
| 4-Month — 7. Other | 6 | 7 |
| 4-Month — Do not know | 2 | 1 |
| 4-Month — Prefer not to answer | 4 | 1 |
We assessed the number of parent/caregiver participants in the OHT arm who agreed to do the challenge (setting the goal of brushing their child's teeth every day, twice per day) that occurred within the 4-month text message program.
| Participants | OHT Group |
|---|---|
| Challenge one | 189 |
| Challenge two | 157 |
Number of primary teeth with new dental caries per child
| Participants | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| 0 teeth with new caries | 91 | 95 |
| 1 tooth with new caries | 19 | 15 |
| 2 teeth with new caries | 13 | 16 |
| 3 to 5 teeth with new caries | 22 | 16 |
| 6 or more teeth with new caries | 15 | 14 |
Collected over Up to 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Health Text Messages (OHT) | 1/377 (0.3%) | 1/377 (0.3%) | 0/377 (0%) |
| Child Wellness Text Messages (CWT) | 0/377 (0%) | 0/377 (0%) | 0/377 (0%) |
| Event | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) |
|---|---|---|
| Death - Probably not related to a study deviceSocial circumstances | 1/377 | — |
754 parent/caregiver-child dyads were assessed for baseline measures (total 1,508 participants)
| Age, Continuous(years) | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) | Total |
|---|---|---|---|
| Parent/caregiver participants | 32.8 ± 7.0 | 33.0 ± 7.4 | 32.9 ± 7.2 |
| Children participants | 2.9 ± 1.7 | 2.8 ± 1.6 | 2.9 ± 1.7 |
| Sex: Female, Male(Participants) | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) | Total |
|---|---|---|---|
| Parent/caregiver participants — Female | 358 | 355 | 713 |
| Parent/caregiver participants — Male | 19 | 22 | 41 |
| Children participants — Female | 186 | 191 | 377 |
| Children participants — Male | 191 | 186 | 377 |
| Ethnicity (NIH/OMB)(Participants) | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) | Total |
|---|---|---|---|
| Parent/caregiver participants — Hispanic or Latino | 98 | 96 | 194 |
| Parent/caregiver participants — Not Hispanic or Latino | 270 | 270 | 540 |
| Parent/caregiver participants — Unknown or Not Reported | 9 | 11 | 20 |
| Children participants — Hispanic or Latino | 114 | 113 | 227 |
| Children participants — Not Hispanic or Latino | 252 | 251 | 503 |
| Children participants — Unknown or Not Reported | 11 | 13 | 24 |
| Race (NIH/OMB)(Participants) | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) | Total |
|---|---|---|---|
| Parent/caregiver participants — American Indian or Alaska Native | 2 | 1 | 3 |
| Parent/caregiver participants — Asian | 7 | 9 | 16 |
| Parent/caregiver participants — Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| Parent/caregiver participants — Black or African American | 235 | 205 | 440 |
| Parent/caregiver participants — White | 46 | 48 | 94 |
| Parent/caregiver participants — More than one race | 25 | 39 | 64 |
| Parent/caregiver participants — Unknown or Not Reported | 61 | 73 | 134 |
| Children participants — American Indian or Alaska Native | 2 | 1 | 3 |
| Children participants — Asian | 6 | 4 | 10 |
| Children participants — Native Hawaiian or Other Pacific Islander | 1 | 1 | 2 |
| Children participants — Black or African American | 225 | 199 | 424 |
| Children participants — White | 33 | 41 | 74 |
| Children participants — More than one race | 58 | 72 | 130 |
| Children participants — Unknown or Not Reported | 52 | 59 | 111 |
| Region of Enrollment(participants) | Oral Health Text Messages (OHT) | Child Wellness Text Messages (CWT) | Total |
|---|---|---|---|
| United States | 754 | 754 | 1508 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Feb 2022, 47 months.
Results were first posted in May 2023, 1 year 2 months after primary completion.
Of 469 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's 47 months is above that.
Counting every sponsor, half of 502 studies reached it within 15 months; a quarter within 7 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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