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School-Based Intervention for Tooth Decay

N/A
Recruiting
Led By Shreela Sharma, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of year 1, year 2 and year 3
Awards & highlights

Study Summary

This trial will test a school-based intervention to reduce the risk of dental caries in low-income, ethnically-diverse children in kindergarten through 2nd grade. Results will help determine the impact of the intervention on child behavioral, psychosocial, and environmental outcomes, and whether these factors mediate improvements in child caries risk.

Who is the study for?
This trial is for children in kindergarten through 2nd grade at schools where most kids get free or reduced lunch. They should be able to do regular school activities and their parents must understand English or Spanish at a 4th-grade level. Kids with certain dental conditions like cleft palate, enamel issues, severe fluorosis, or those needing special dental care can't join.Check my eligibility
What is being tested?
The study tests CATCH Healthy Smiles, a program aimed at reducing tooth decay by changing behavior in young students from low-income families. It compares results between schools that use the program (Intervention Group) and those that don't (Comparison Group).See study design
What are the potential side effects?
Since this is an educational intervention focusing on oral health behaviors rather than medication, there are no direct side effects like you would expect with drugs. However, it's important to monitor for any unintended consequences of the behavioral changes promoted.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of year 1, year 2 and year 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, end of year 1, year 2 and year 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Secondary outcome measures
Change in Body Mass Index (BMI)
Change in Child Oral health quality of life measured using parent self-report surveys
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention School GroupExperimental Treatment1 Intervention
Group II: Comparison School GroupActive Control1 Intervention

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
319,931 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
847,278 Total Patients Enrolled
Shreela Sharma, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
1 Previous Clinical Trials
620 Total Patients Enrolled

Media Library

CATCH Healthy Smiles Clinical Trial Eligibility Overview. Trial Name: NCT04632667 — N/A
Tooth Decay Research Study Groups: Comparison School Group, Intervention School Group
Tooth Decay Clinical Trial 2023: CATCH Healthy Smiles Highlights & Side Effects. Trial Name: NCT04632667 — N/A
CATCH Healthy Smiles 2023 Treatment Timeline for Medical Study. Trial Name: NCT04632667 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate participant count for this clinical trial?

"Affirmative. According to the data housed on clinicaltrials.gov, this medical investigation is actively enrolling participants since February 5th 2022 and its last edit was made in June 9th of the same year. The study requires 1066 individuals from a single location for completion."

Answered by AI

Is this clinical trial open to participants over the age of eighty?

"This medical study is only open to patients aged 5-9. For minors under 18, there are 55 different trials available; for those over 65 the number of applicable studies rises to 31."

Answered by AI

Are patient enrolments still being accepted for this clinical investigation?

"According to the data on clinicaltrials.gov, this medical experiment is currently in need of participants. It was initially advertised on February 5th 2022 and has been freshly updated as recent as June 9th 2022."

Answered by AI

What criteria should be met to qualify for involvement in this investigation?

"This clinical trial is enrolling 1066 children aged 5 to 9 who suffer from dental caries. They must also agree to comply with the CATCH Healthy Smiles program, be able to keep up with normal school activities, and attend a participating school in kindergarten during 2021-2022 while at least 75% of their peers are enrolled in free/reduced lunch programs."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
The University of Texas Health Science Center at Houston
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial
Shreela V Sharma 2022. "CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04632667.
~512 spots leftby Apr 2026
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