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N/A N=1,305 Randomized Quadruple-blind Health Services Research

Family Access to Dentist Study

Dental Caries

Enrolled (actual)
1,305
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants With Receipt of Dental Care-restoration or Extraction of at Least One Tooth at Final Exam — 68; 76; 8; 14 Participants — p=<0.05

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Standard letter (Behavioral); Intervention letter (Behavioral); Reduced intervention letter (Behavioral); DIG (Behavioral); Reduced DIG (Behavioral)
Age
Pediatric · 5+ yrs
Sex
All
Sponsor
Case Western Reserve University
Primary completion
May 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Receipt of Dental Care-restoration or Extraction of at Least One Tooth at Final Exam
68; 76; 8; 14; 71 <0.05 sig
SECONDARY
Change in Illness Perception Assessed by IPQ-RD
-2.65; -2.79; -1.96; 1.96; -1.10
SECONDARY
Number of Caregivers With Change in Behavioral Intention
25; 34; 1; 5; 33

Summary

The study is a multi-site, double blind, parallel arm, community-based randomized controlled trial (phase III RCT) to evaluate the effectiveness of new referral approaches to increase receipt of dental care among inner-city urban and rural elementary school children who were screened at school and have restorative treatment needs. The study has 5 arms: The experimental intervention is the use of a theoretically driven CSM referral letter alone, the letter plus a Dental Information Guide, a reduced CSM referral letter alone, or a reduced CSM referral letter plus a reduced Dental Information Guide. The control strategy is the use of a standard referral letter. All participating K-4 grade children will receive a screening at the beginning of the school year and at the study end point 7 months later to determine if the child received dental care. Due to lower than expected enrollment in both the Ohio and Washington sites, a second year of recruitment was added to include Bedford School District and East Cleveland School District (only KG and other grades if they did not enroll in the first year). The same study procedures, schedule and design was utilized for the second year of recruitment. The primary aim is to evaluate the effectiveness of experimental (new) versus standard referral approach given to parents/caregivers in increasing receipt of dental care among their children in grades K-4. The secondary aim is to assess changes in parent/caregiver illness representation/perception and behavioral intention between enrollment (beginning of school year) and follow-up (end of school year) to understand the underlying mechanisms of the new vs. standard referral approach that result in receipt of dental care. The hypothesis is that CSM-based interventions will increase receipt of dental care compared to the standard referral letter.

Eligibility Criteria

Inclusion Criteria: (parents/caregivers and their children)

  • Provide signed and dated consent form (also assent form for children 7 and older)
  • Willing to comply with all study procedures and be available for the duration of the study
  • Male or female child, grades K-4
  • Child in good general health as evidenced by parent report (including children with special health care needs)
  • Based on the beginning of the school year dental screening, caregivers will be randomized if their child has tooth with an International Caries Detection and Assessment System (ICDAS) active lesion score of ≥ 2

Exclusion Criteria: (parents/caregivers)

  • Illiterate
  • Non-English speaking (in East Cleveland Public Schools)
  • Under 18 years of age
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02395120). 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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