Caries, DentaliSmileNCT03294590
Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
A study testing OHT Parent targeted text messages and CWT Parent targeted text messages in people with Caries, Dental and Health Behavior, run by Boston University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 0 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Dental, Health Behavior
- What is being tested?
- OHT Parent targeted text messages and CWT Parent targeted text messages
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 754 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2018to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 0 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Inclusion Criteria: Caregiver and child must meet all of the following:
- Caregiver must be a parent or legal guardian of a child less than 7 years old, and the child must have their first tooth showing
- The child must receive medical care at one of the participating pediatric clinics.
- Speak, understand, and read either English or Spanish
- Have a mobile phone.
Exclusion Criteria: If the caregiver or child meets any of the following criteria, the dyad will be excluded from participation in this study
- Children with severe congenital tooth malformations: At screening the caregiver will be asked if their child has known systemic diseases associated with abnormal tooth development or abnormal oral health status such as cleft lip or palate, amelogenesis imperfecta, or dentinogenesis imperfecta.
- Children who cannot complete the baseline oral health exam.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
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.
- Conditions
- Caries, Dental, Health Behavior
- Being tested
- OHT Parent targeted text messages, CWT Parent targeted text messages
- Keywords
- Child oral health behaviors, Text messages, Motivation, Self efficacy, Outcome Expectations, Sugar sweetened beverage consumption, Fluoride varnish, Healthy eating, Parent oral health behaviors, Parent oral health attitudes, Fluoride, early childhood caries
- Medical subject headings
- Dental Caries, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHT Parent targeted text messagesOther
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.
CWT Parent targeted text messagesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral health text messages (OHT) | Experimental | 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. Receives: Other: OHT Parent targeted text messages |
| Child wellness text messages (CWT) | Active comparator | 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. Receives: Other: CWT Parent targeted text messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 24-month time point (oral assessment)
Secondary outcomes (16)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 4-month time point (survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start9 Mar 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries, DentalStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Belinda Borrelli, PhD, Principal investigator, Henry M. Goldman School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294590
- Sponsor's protocol ID
- H-36857
- Other IDs
- 4UH3DE025492-03
- Acronym
- iSmile
- Status last verified
- Oct 2023
- First submitted
- 21 Sep 2017
- Last updated
- 24 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borrelli B, Endrighi R, Heeren T, Adams WG, Gansky SA, Werntz S, Rueras N, Stephens D, Ameli N, Henshaw MM. Parent-Targeted Oral Health Text Messaging for Underserved Children Attending Pediatric Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452780. doi: 10.1001/jamanetworkopen.2024.52780.
PubMed 39745701
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children
- ClinicalTrials.gov ID
- NCT03294590
- Acronym / sponsor ID
- iSmile / H-36857
- Conditions
- Caries, Dental, Health Behavior
- Keywords
- Child oral health behaviors, Text messages, Motivation, Self efficacy, Outcome Expectations, Sugar sweetened beverage consumption, Fluoride varnish, Healthy eating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 27 Sep 2017 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral health text messages (OHT) | Experimental | Other: OHT Parent targeted text messagesParticipants 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. |
| Child wellness text messages (CWT) | Active comparator | Other: CWT Parent targeted text messagesParticipants 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. |
Who may qualify
- Ages
- 0 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
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 |
|---|---|---|
| OHT Parent targeted text messagesFor 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. | Other | Oral health text messages (OHT) |
| CWT Parent targeted text messagesFor 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. | Other | Child wellness text messages (CWT) |
Primary outcome
Dental Caries Increment
Time frame: 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).
Parent/Caregiver Confidence to Brush
Time frame: 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)
Parent/Caregiver Motivation to Perform Oral Health Behaviors
Time frame: 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)
Parent/Caregiver Outcome Expectations for Oral Health Behaviors
Time frame: 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).
Self-efficacy to Perform Oral Health Behaviors
Time frame: 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).
Dental Caries Increment (Surface Level)
Time frame: 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).
16 secondary outcomes
Text Message Program Length Satisfaction
Time frame: 4-month time point (survey)
Parents' Perceived Impact of iSmile
Time frame: 4-month time point (survey)
Child Preventive Dental Visits
Time frame: 4-month, 12-month, and 24-month time points (survey)
Fluoridated Toothpaste Use
Time frame: 4-month, 12-month, and 24-month time points (survey)
Perceived Impact of OHT Program on Parental Awareness
Time frame: 24-month (survey)
Child Diet - Food Frequency
Time frame: 4-month, 12-month, and 24-month time points (survey)
Child Diet - Beverage Intake
Time frame: 4-month, 12-month, and 24-month time points (survey)
Child Tooth Brushing
Time frame: 4-month, 12-month, and 24-month time points (survey)
Parent/Caregiver Tooth Brushing
Time frame: 4-month, 12-month, and 24-month time points (survey)
Child Oral Health-related Quality of Life
Time frame: 4-month, 12-month, and 24-month time points (survey)
Satisfaction With Text Message Program Features
Time frame: 4-month time point (survey)
Child Toothbrushing (Clinical Guidelines)
Time frame: 4-month, 12-month, and 24-month time points (survey)
Parents/Caregivers Toothbrushing (Clinical Guidelines)
Time frame: 4-month, 12-month, and 24-month time points (survey)
Diffusion of Text Messages (Satisfaction)
Time frame: 4-month time point (survey)
Text Message Program Star Rating
Time frame: 4-month time point (survey)
Text Message Program Quality
Time frame: 4-month time point (survey)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39745701Borrelli B, Endrighi R, Heeren T, Adams WG, Gansky SA, Werntz S, Rueras N, Stephens D, Ameli N, Henshaw MM. Parent-Targeted Oral Health Text Messaging for Underserved Children Attending Pediatric Clinics: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452780. doi: 10.1001/jamanetworkopen.2024.52780.
- Individual participant dataSharing planned: No
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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.
Belinda Borrelli, PhD principal investigator
Henry M. Goldman School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OHT Parent targeted text messages and CWT Parent targeted text messages in people with Caries, Dental and Health Behavior, run by Boston University 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?
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 24 Oct 2023. 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?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dental Caries Increment (time frame: 24-month time point (oral assessment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03294590, which also lists 1 linked publication.
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 24 Oct 2023.