Adults 0 Months to 7, any sex, with Caries, Dental or Health Behavior. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Dental Caries IncrementPrimary· 24-month time point (oral assessment)
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).
Group
Value
95% CI
Oral Health Text Messages (OHT)
162
Child Wellness Text Messages (CWT)
161
Parent/Caregiver Confidence to BrushPrimary· 4-month time point (survey)
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)
Group
Value
95% CI
Oral Health Text Messages (OHT)
2.9
± 1.2
Child Wellness Text Messages (CWT)
2.8
± 1.2
Parent/Caregiver Motivation to Perform Oral Health BehaviorsPrimary· 4-month time point (survey)
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)
Group
Value
95% CI
Oral Health Text Messages (OHT)
6.2
± 1.2
Child Wellness Text Messages (CWT)
6.0
± 1.3
Parent/Caregiver Outcome Expectations for Oral Health BehaviorsPrimary· 4-month time point (survey)
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).
Group
Value
95% CI
Oral Health Text Messages (OHT)
3.69
± 0.67
Child Wellness Text Messages (CWT)
3.68
± 0.60
Self-efficacy to Perform Oral Health BehaviorsPrimary· 4-month time point (survey)
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).
Group
Value
95% CI
Oral Health Text Messages (OHT)
6.3
± 1.1
Child Wellness Text Messages (CWT)
6.2
± 1.2
Dental Caries Increment (Surface Level)Primary· 24-month time point (oral assessment)
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).
Group
Value
95% CI
Oral Health Text Messages (OHT)
545
Child Wellness Text Messages (CWT)
496
Text Message Program Length SatisfactionSecondary· 4-month time point (survey)
One item adapted from the Mobile App Rating Scale (MARS) to measure parent/caregiver participants satisfaction with the duration of the text message program.
Group
Value
95% CI
Oral Health Text Messages (OHT)
193
Child Wellness Text Messages (CWT)
172
Oral Health Text Messages (OHT)
68
Child Wellness Text Messages (CWT)
80
Oral Health Text Messages (OHT)
29
Child Wellness Text Messages (CWT)
36
Parents' Perceived Impact of iSmileSecondary· 4-month time point (survey)
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).
Making sure your child's teeth are brushed
Group
Value
95% CI
OHT Group
6.4
± 1.3
Decreasing the amount of sugar-sweetened beverages your child drinks
Group
Value
95% CI
OHT Group
5.9
± 1.8
Your feelings on taking your child to the dentist
Group
Value
95% CI
OHT Group
6.1
± 1.6
Child Preventive Dental VisitsSecondary· 4-month, 12-month, and 24-month time points (survey)
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.
24-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
207
Child Wellness Text Messages (CWT)
181
12-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
180
Child Wellness Text Messages (CWT)
157
4-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
162
Child Wellness Text Messages (CWT)
131
Fluoridated Toothpaste UseSecondary· 4-month, 12-month, and 24-month time points (survey)
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.
24-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
225
Child Wellness Text Messages (CWT)
207
12-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
229
Child Wellness Text Messages (CWT)
215
4-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
225
Child Wellness Text Messages (CWT)
210
Perceived Impact of OHT Program on Parental AwarenessSecondary· 24-month (survey)
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.
Group
Value
95% CI
OHT Group
7
OHT Group
3
OHT Group
14
OHT Group
33
Child Diet - Food FrequencySecondary· 4-month, 12-month, and 24-month time points (survey)
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).
24-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
2.22
± 0.31
Child Wellness Text Messages (CWT)
2.27
± 0.27
12-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
2.23
± 0.30
Child Wellness Text Messages (CWT)
2.23
± 0.24
4-month
Group
Value
95% CI
Oral Health Text Messages (OHT)
2.18
± 0.28
Child Wellness Text Messages (CWT)
2.22
± 0.24
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 24 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston University
Last refreshed: 24 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03294590.