Caries,DentalNCT04632667
CATCH Healthy Smiles:An Elementary School Oral Health Intervention Trial
A study testing Comparison School Group and Intervention School Group in people with Caries,Dental, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 9 years
- Conditions the study is for
- Caries,Dental
- What is being tested?
- Comparison School Group and Intervention School Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,084 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- -No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention
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.
- Conditions
- Caries,Dental
- Being tested
- Comparison School Group, Intervention School Group
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison School GroupBehavioural
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.
Intervention School GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Comparison School Group | Active comparator | Not described Receives: Behavioral: Comparison School Group |
| Intervention School Group | Experimental | Not described Receives: Behavioral: Intervention School Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Measured: Baseline(beginning of kindergarten)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Measured: end of year 1(Kindergarten)
Number of tooth and tooth surfaces that became decayed or were treated for dental caries (by filling or extraction)
Measured: 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)
Measured: end of year 3( second grade)
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: end of year 3
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Measured: Baseline
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Measured: 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
Measured: 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
Measured: End of year 3 about 33 months from start of intervention
Number of times a child brushes their teeth a day
Measured: Baseline
Number of times a child brushes their teeth a day
Measured: end of year 1 about 9 months from start of intervention
Number of times a child brushes their teeth a day
Measured: End of year 2 about 23 months from start of intervention
Number of times a child brushes their teeth a day
Measured: 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.
Measured: baseline, end of Year 1, Year 2 and Year 3
Change in Child Oral health quality of life measured using parent self-report surveys
Measured: baseline, end of Year 1, Year 2 and Year 3
Frequency of flossing teeth for the child measured using parent self-report surveys
Measured: Baseline
Frequency of flossing teeth for the child measured using parent self-report surveys
Measured: end of year 1
Frequency of flossing teeth for the child measured using parent self-report surveys
Measured: end of year 2
Frequency of flossing teeth for the child measured using parent self-report surveys
Measured: end of year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start5 Feb 2022
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Schools will be cluster randomized to the intervention or comparison group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,084 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Shreela V Sharma, The University of Texas Health Science Center, Houston
- Investigators
- Shreela Sharma, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632667
- Sponsor's protocol ID
- HSC-SPH-19-0838
- Status last verified
- Jul 2025
- First submitted
- 12 Oct 2020
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36387989
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CATCH Healthy Smiles: A Cluster-RCT of an Elementary School Oral Health Intervention
- ClinicalTrials.gov ID
- NCT04632667
- Acronym / sponsor ID
- HSC-SPH-19-0838
- Conditions
- Caries,Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,084 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Schools will be cluster randomized to the intervention or comparison group
| Arm | Type | Receives |
|---|---|---|
| Comparison School Group | Active comparator | Behavioral: Comparison School Group |
| Intervention School Group | Experimental | Behavioral: Intervention School Group |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- -No congenital dental conditions such as cleft palate, children with enamel hypoplasia, severe fluorosis, or special dental setting needs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison School GroupAll 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. | Behavioural | Comparison School Group |
| Intervention School GroupThis 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. | Behavioural | Intervention School Group |
Primary outcome
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)
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)
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)
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)
22 secondary outcomes
Number of children with good oral hygiene as measured by the child plaque index
Time frame: Baseline
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
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
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
Child dietary intake as measured by the Block food frequency screener
Time frame: Baseline
Child dietary intake as measured by the Block food frequency screener
Time frame: end of year 1
Child dietary intake as measured by the Block food frequency screener
Time frame: end of year 2
Child dietary intake as measured by the Block food frequency screener
Time frame: end of year 3
Child and parent behavioral, psychosocial and environmental factors will be measured using self-report surveys
Time frame: Baseline
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
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
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
Number of times a child brushes their teeth a day
Time frame: Baseline
Number of times a child brushes their teeth a day
Time frame: end of year 1 about 9 months from start of intervention
Number of times a child brushes their teeth a day
Time frame: End of year 2 about 23 months from start of intervention
Number of times a child brushes their teeth a day
Time frame: End of year 3 about 33 months from start of intervention
Change in Body Mass Index (BMI)
Time frame: baseline, end of Year 1, Year 2 and Year 3
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
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: Baseline
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: end of year 1
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: end of year 2
Frequency of flossing teeth for the child measured using parent self-report surveys
Time frame: end of year 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Derived from this study: PubMed 36387989Chuang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shreela Sharma, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison School Group and Intervention School Group in people with Caries,Dental, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.