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N/A N=754 Randomized Double-blind Prevention

Interactive Parent-Targeted Text Messaging in Pediatric Clinics to Reduce Caries Among Urban Children

Caries, Dental · Health Behavior

Enrolled (actual)
754
Serious AEs
0.1%
Results posted
May 2023
Primary outcome: Primary: Dental Caries Increment — 162; 161 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
OHT Parent targeted text messages (Other); CWT Parent targeted text messages (Other)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
Boston University
Primary completion
Feb 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Dental Caries Increment
162; 161
PRIMARY
Parent/Caregiver Confidence to Brush
2.9; 2.8
PRIMARY
Parent/Caregiver Motivation to Perform Oral Health Behaviors
6.2; 6.0
PRIMARY
Parent/Caregiver Outcome Expectations for Oral Health Behaviors
3.69; 3.68
PRIMARY
Self-efficacy to Perform Oral Health Behaviors
6.3; 6.2
PRIMARY
Dental Caries Increment (Surface Level)
545; 496
SECONDARY
Text Message Program Length Satisfaction
193; 172; 68; 80; 29; 36
SECONDARY
Parents' Perceived Impact of iSmile
6.4; 5.9; 6.1
SECONDARY
Child Preventive Dental Visits
207; 181; 180; 157; 162; 131
SECONDARY
Fluoridated Toothpaste Use
225; 207; 229; 215; 225; 210
SECONDARY
Perceived Impact of OHT Program on Parental Awareness
7; 3; 14; 33; 207; 8
SECONDARY
Child Diet - Food Frequency
2.22; 2.27; 2.23; 2.23; 2.18; 2.22
SECONDARY
Child Diet - Beverage Intake
125; 142; 145; 131; 128; 141
SECONDARY
Child Tooth Brushing
12.0; 11.1; 12.0; 11.6; 12.9; 11.3
SECONDARY
Parent/Caregiver Tooth Brushing
12.7; 12.3; 12.7; 12.5; 13.1; 12.4
SECONDARY
Child Oral Health-related Quality of Life
1.03; 0.99; 1.14; 0.96; 0.65; 0.80
SECONDARY
Satisfaction With Text Message Program Features
6.12; 6.04
SECONDARY
Child Toothbrushing (Clinical Guidelines)
177; 147; 167; 160; 214; 156
SECONDARY
Parents/Caregivers Toothbrushing (Clinical Guidelines)
188; 175; 195; 183; 208; 191
SECONDARY
Diffusion of Text Messages (Satisfaction)
168; 177
SECONDARY
Text Message Program Star Rating
1; 3; 12; 7; 43; 50
SECONDARY
Text Message Program Quality
5.81; 5.56; 6.0; 6.0; 6.5; 6.6

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). 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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03294590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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