CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial

• ClinicalTrials.gov Identifier: NCT04632667
• Recruitment Status: Recruiting
• First Posted: November 17, 2020
• Last Update Posted: June 14, 2022
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR)
• Information provided by (Responsible Party): Shreela V Sharma, The University of Texas Health Science Center, Houston

Study Description

Brief Summary:

The purpose of this study is to clinically evaluate the effects of a school-based behavioral intervention, CATCH Healthy Smiles, to reduce the risk of dental caries in a cohort of kindergarten through 2nd grade (K-2) children serving low-income, ethnically-diverse children,to determine the impact of CATCH Healthy Smiles on child behavioral, psychosocial, and environmental outcomes beginning in K through 2nd grade, compared to children in the control schools and to examine the extent to which the child behavioral, psychosocial, and environmental factors mediate the improvements in child caries risk.

Condition or disease	Intervention/treatment	Phase
Caries,Dental	Behavioral: Comparison School Group; Behavioral: Intervention School Group	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1066 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Schools will be cluster randomized to the intervention or comparison group
• Masking: Single (Investigator)
• Masking Description: For post measurements, all data collection staff will be blinded to the intervention status.
• Primary Purpose: Prevention
• Official Title: CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention
• Actual Study Start Date: February 5, 2022
• Estimated Primary Completion Date: April 30, 2026
• Estimated Study Completion Date: April 30, 2026

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Comparison School Group	Behavioral: Comparison School Group; All control schools will receive training and materials for the CATCH sun safety curriculum. Ray and the Sunbeatables®: A Sun Safety Curriculum is an evidence-based curriculum educates children, parents and teachers about sun protection and promotes sun safety behaviors in an effort to reduce children's lifetime risk of developing skin cancer. Training will be conducted with booster trainings yearly.
Experimental: Intervention School Group	Behavioral: Intervention School Group; This intervention includes toothbrushing which will be implemented as a daily activity to develop skills and technique,classroom curriculum, which includes theory-based interactive lessons on oral health care,the physical education component consisting of an activity box containing different structured physical activities that will integrate the nutrition and oral health education messages, all cafeteria-based intervention materials including the "tooth friendly" Eat Smart guide, signage, nutrition labeling, menu planning and labeling using the tooth-friendly Go-Slow-Whoa CATCH terminology will be provided to the food service staff that is displayed across the cafeteria and sent home to parents and parents will be provided with tools and tips for maintaining oral health with website resources,parent-child homework activities, send-home infographics on dental care, parent-monitored tracking of child oral health,family fun nights in schools, and social media.

Outcome Measures

Primary Outcome Measures :

1. Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) [ Time Frame: Baseline(beginning of kindergarten) ]
2. Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) [ Time Frame: end of year 1(Kindergarten) ]
3. Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) [ Time Frame: end of year 2(first grade) ]
4. number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) [ Time Frame: end of year 3( second grade) ]

Secondary Outcome Measures :

1. Number of children with good oral hygiene as measured by the child plaque index [ Time Frame: Baseline ]
   The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
2. Number of children with good oral hygiene as measured by the child plaque index [ Time Frame: end of year 1 about 9 months form start of intervention ]
   The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
3. Number of children with good oral hygiene as measured by the child plaque index [ Time Frame: end of year 2 about 23 months from start of intervention ]
   The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
4. Number of children with good oral hygiene as measured by the child plaque index [ Time Frame: end of year 3 about 33 months form start of intervention ]
   The plaque score will be measured using the plaque index of Silness and Loe. Six teeth will be examined for presence of plaque/ materia alba and food remnants and calculus. The index will be a numerical score (0-3) as follows: 0 = No Debris or stain; 1 = Soft debris or stain covering no more than 1/3 of tooth surface; 2 = Soft debris or stain covering more than 1/3 of tooth surface and less than 2/3 of tooth surface; 3 = Soft debris or stain covering more than 2/3 of tooth surface.
5. Child dietary intake as measured by the Block food frequency screener [ Time Frame: Baseline ]
   This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
6. Child dietary intake as measured by the Block food frequency screener [ Time Frame: end of year 1 ]
   This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
7. Child dietary intake as measured by the Block food frequency screener [ Time Frame: end of year 2 ]
   This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
8. Child dietary intake as measured by the Block food frequency screener [ Time Frame: end of year 3 ]
   This tools helps to find out how many times a week different kinds of food was consumed and how much quantity of food was consumed each day
9. Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys [ Time Frame: Baseline ]
10. Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys [ Time Frame: end of year 1 about 9 months from start of intervention ]
11. Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys [ Time Frame: End of year 2 about 23 months from start of intervention ]
12. Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys [ Time Frame: End of year 3 about 33 months from start of intervention ]
13. Number of times a child brushes their teeth a day [ Time Frame: Baseline ]
14. Number of times a child brushes their teeth a day [ Time Frame: end of year 1 about 9 months from start of intervention ]
15. Number of times a child brushes their teeth a day [ Time Frame: End of year 2 about 23 months from start of intervention ]
16. Number of times a child brushes their teeth a day [ Time Frame: End of year 3 about 33 months from start of intervention ]
17. Change in Body Mass Index (BMI) [ Time Frame: baseline, end of Year 1, Year 2 and Year 3 ]
    Child height and weight measured at the school using stadiometers and digital scales respectively.
18. Change in Child Oral health quality of life measured using parent self-report surveys [ Time Frame: baseline, end of Year 1, Year 2 and Year 3 ]
19. Frequency of flossing teeth for the child measured using parent self-report surveys [ Time Frame: Baseline ]
20. Frequency of flossing teeth for the child measured using parent self-report surveys [ Time Frame: end of year 1 ]
21. Frequency of flossing teeth for the child measured using parent self-report surveys [ Time Frame: end of year 2 ]
22. Frequency of flossing teeth for the child measured using parent self-report surveys [ Time Frame: end of year 3 ]

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 9 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

For schools:

• greater than 75% of the children enrolled in the dree/reduced school lunch program.
• enrolling children in grade K in the 2021-2022 school year.
• agree to implement the CATCH Healthy Smiles program and agreed to participate in the measurements

For parent and child to participate in the measures:

• ability of the parent to speak and read in English or Spanish at the 4th grade level,
• child enrolled in the participating school in grade K in the 2021-2022 school year
• child ability to participate in the regular activities at the school

Exclusion Criteria:

-No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.

Contacts and Locations

Contacts

Contact: Shreela Sharma, PhD; (713) 500-9344; Shreela.V.Sharma@uth.tmc.edu

Contact: Ru-Jye Chuang, DrPH; (713) 500-9383; Ru-Jye.Chuang@uth.tmc.edu

Locations

United States, Texas

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Contact: Shreela Sharma, PhD 713-500-9344 Shreela.V.Sharma@uth.tmc.edu

Contact: Ru-Jye Chuang, DrPh (713) 500-9383 Ru-Jye.Chuang@uth.tmc.edu

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Principal Investigator: Shreela Sharma, PhD; The University of Texas Health Science Center, Houston

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chuang RJ, Byrd-Williams C, Yamal JM, Johnson K, Kelder S, Nelson S, Mofleh D, Sharma SV. Design for a cluster randomized controlled trial to evaluate the effects of the CATCH Healthy Smiles school-based oral health promotion intervention among elementary school children. Contemp Clin Trials Commun. 2022 Nov 5;30:101033. doi: 10.1016/j.conctc.2022.101033. eCollection 2022 Dec.

• Responsible Party: Shreela V Sharma, Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT04632667
• Other Study ID Numbers: HSC-SPH-19-0838
• First Posted: November 17, 2020
• Last Update Posted: June 14, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dental Caries; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases