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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison School Group | Active Comparator |
| |
| Intervention School Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison School Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) | Baseline(beginning of kindergarten) | |
| Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) | end of year 1(Kindergarten) | |
| Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) | end of year 2(first grade) | |
| number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction) | end of year 3( second grade) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of children with good oral hygiene as measured by the child plaque index | 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. |
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Inclusion Criteria:
For schools:
For parent and child to participate in the measures:
Exclusion Criteria:
-No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
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| Name | Affiliation | Role |
|---|---|---|
| Shreela Sharma, PhD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36387989 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Schools will be cluster randomized to the intervention or comparison group
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For post measurements, all data collection staff will be blinded to the intervention status.
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| Intervention School Group | Behavioral | 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. |
|
| Baseline |
| Number of children with good oral hygiene as measured by the child plaque index | 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. | end of year 1 about 9 months form start of intervention |
| Number of children with good oral hygiene as measured by the child plaque index | 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. | end of year 2 about 23 months from start of intervention |
| Number of children with good oral hygiene as measured by the child plaque index | 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. | end of year 3 about 33 months form start of intervention |
| Child dietary intake as measured by the Block food frequency screener | 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 | Baseline |
| Child dietary intake as measured by the Block food frequency screener | 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 | end of year 1 |
| Child dietary intake as measured by the Block food frequency screener | 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 | end of year 2 |
| Child dietary intake as measured by the Block food frequency screener | 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 | end of year 3 |
| Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys | Baseline |
| Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys | end of year 1 about 9 months from start of intervention |
| Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys | End of year 2 about 23 months from start of intervention |
| Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys | End of year 3 about 33 months from start of intervention |
| Number of times a child brushes their teeth a day | Baseline |
| Number of times a child brushes their teeth a day | end of year 1 about 9 months from start of intervention |
| Number of times a child brushes their teeth a day | End of year 2 about 23 months from start of intervention |
| Number of times a child brushes their teeth a day | End of year 3 about 33 months from start of intervention |
| Change in Body Mass Index (BMI) | Child height and weight measured at the school using stadiometers and digital scales respectively. | baseline, end of Year 1, Year 2 and Year 3 |
| Change in Child Oral health quality of life measured using parent self-report surveys | baseline, end of Year 1, Year 2 and Year 3 |
| Frequency of flossing teeth for the child measured using parent self-report surveys | Baseline |
| Frequency of flossing teeth for the child measured using parent self-report surveys | end of year 1 |
| Frequency of flossing teeth for the child measured using parent self-report surveys | end of year 2 |
| Frequency of flossing teeth for the child measured using parent self-report surveys | end of year 3 |