Tooth DecayNCT04845594
Efficacy Trial of MySmileBuddy
A study testing MySmileBuddy (MSB) in people with Tooth Decay, run by Columbia University.
Trial summary
This study seeks to evaluate the best way to encourage a healthy diet and proper fluoride use in children at greatest risk for tooth decay. To do so, this study will evaluate whether or not a family focused intervention, MySmileBuddy, is able to reduce tooth decay progression in Hispanic preschoolers at high risk of… Read more about this study
- Who is it for?
- Ages 24 to 71 months
- Conditions the study is for
- Tooth Decay
- What is being tested?
- MySmileBuddy (MSB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to 2 Dec 2020
- 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 24 to 71 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 24 to 71 months of age, have a minimum of 12 teeth present, and have early childhood caries (ECC)
- Will reside in the New York City (NYC) metropolitan for the following 12 months
- Parents must be 18 years or older and must report having a cell phone with texting capabilities
Who cannot join
- Children with developmental delays or medical conditions that would impede oral dietary intake, at-home oral hygiene practices, or receipt of oral exams
- Children with parents who are under the age of 18 years of age, do not report having a mobile phone, do not plan to reside in the New York City (NYC) metropolitan area for the following 12 months
- Children of parents who do not provide consent to participate.
About this study
Official title: Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries
This study seeks to evaluate the best way to encourage a healthy diet and proper fluoride use in children at greatest risk for tooth decay. To do so, this study will evaluate whether or not a family focused intervention, MySmileBuddy, is able to reduce tooth decay progression in Hispanic preschoolers at high risk of this disease.
Read the detailed description
Tooth decay in young children has traditionally been treated through surgical dental repair, an approach that does not address the oral hygiene and dietary behaviors that cause the disease. Professionals agree that behavioral strategies to prevent tooth decay are needed, but they have not been well studied in Hispanic children in the United States that have disproportionately high rates of this disease. Use of fluoridated toothpaste twice a day and consumption of a healthy diet can both prevent tooth decay and stop it from progressing.
- Conditions
- Tooth Decay
- Being tested
- MySmileBuddy (MSB)
- Keywords
- Oral hygiene, Decay, Decay Progression
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MySmileBuddy (MSB)Behavioural
Also called MSB
The technology-based MSB program equips community health workers (CHWs) with an iPad-based app that facilitates assessment of a child's early childhood caries (ECC).
| Study group | Role | What they receive |
|---|---|---|
| MySmileBuddy | Experimental | Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will receive a family-focused intervention called MySmileBuddy. Receives: Behavioral: MySmileBuddy (MSB) |
| Control | No intervention | Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Decayed, Missing, or Filled Teeth or Surfaces
Early childhood caries status will be determined by visual examination, assisted by an examination light, mirror, and probe with caries experience defined by number of teeth (t) and surfaces (s) that either have decay (d), are missing due to decay (m), or have had a dental filling (f) due to a cavity.
Measured: 12 months post-randomization
Proportion of Participants with Early Childhood Caries Progression
The number of decayed, missing, or filled teeth (dmft)/decayed filled surfaces (dfs) as a count variable will be measured to determine the proportion of participants who have a positive change in the number of dmft/dfs post-intervention.
Measured: 12 months post-randomization
Secondary outcomes (2)
Change in Twice Daily Fluoridated Toothpaste Use
Tooth brushing behaviors will be assess by asking parents a series of multiple choice and open-ended questions and direct observation of tooth brushing behavior measured using the Tooth Brushing Observation Scale (Collett, et al., 2016) at baseline (T1) and 12 months post-randomization (T2).
Measured: 12 months post-randomization
Change in Consumption of a Low Cariogenic Diet
Cariogenic diet behaviors will be assessed by asking parents a series of multiple choice and open-ended questions using: (1) an age-appropriate modification of the University of Iowa's Diet Assessment of Caries Risk tool (Marshall, 2009); and (2) the MSB-developed modified 24-hour dietary recall widget.
Measured: 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study startOct 2019 (estimated)
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
Why it stopped: This study was halted prior to the start of enrollment due to the COVID-19 pandemic. The inability to conduct planned in-person intervention activities during the pandemic related to inherent risks of the virus necessitated withdrawal of the study.
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 Tooth DecayStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Carol Kunzel, Columbia University
- Investigators
- Carol Kunzel, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845594
- Sponsor's protocol ID
- AAAR7549
- Other IDs
- 1U01DE026739-01A1
- Status last verified
- Apr 2021
- First submitted
- 9 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lumsden CL, Edelstein BL, Basch CE, Wolf RL, Koch PA, McKeague I, Leu CS, Andrews H. Protocol for a family-centered behavioral intervention to reduce early childhood caries: the MySmileBuddy program efficacy trial. BMC Oral Health. 2021 May 7;21(1):246. doi: 10.1186/s12903-021-01582-4.
PubMed 33962602
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Efficacy Trial of MySmileBuddy, a Family-centered Behavioral Intervention to Reduce Early Childhood Caries
- ClinicalTrials.gov ID
- NCT04845594
- Acronym / sponsor ID
- AAAR7549
- Conditions
- Tooth Decay
- Keywords
- Oral hygiene, Decay, Decay Progression
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was halted prior to the start of enrollment due to the COVID-19 pandemic. The inability to conduct planned in-person intervention activities during the pandemic related to inherent risks of the virus necessitated withdrawal of the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Oct 2019 (estimated)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (actual)
- First posted
- 15 Apr 2021 (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.
This study seeks to evaluate the best way to encourage a healthy diet and proper fluoride use in children at greatest risk for tooth decay. To do so, this study will evaluate whether or not a family focused intervention, MySmileBuddy, is able to reduce tooth decay progression in Hispanic preschoolers at high risk of this disease.
Detailed description
Tooth decay in young children has traditionally been treated through surgical dental repair, an approach that does not address the oral hygiene and dietary behaviors that cause the disease. Professionals agree that behavioral strategies to prevent tooth decay are needed, but they have not been well studied in Hispanic children in the United States that have disproportionately high rates of this disease. Use of fluoridated toothpaste twice a day and consumption of a healthy diet can both prevent tooth decay and stop it from progressing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MySmileBuddy | Experimental | Behavioral: MySmileBuddy (MSB)Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will receive a family-focused intervention called MySmileBuddy. |
| Control | No intervention | –Children, aged 24-71 months of age, who have tooth decay will be enrolled, along with their caregiver, and will not receive any intervention. |
Who may qualify
- Ages
- 24 to 71 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 24 to 71 months of age, have a minimum of 12 teeth present, and have early childhood caries (ECC)
- Will reside in the New York City (NYC) metropolitan for the following 12 months
- Parents must be 18 years or older and must report having a cell phone with texting capabilities
Key exclusion criteria (3 listed)
- Children with developmental delays or medical conditions that would impede oral dietary intake, at-home oral hygiene practices, or receipt of oral exams
- Children with parents who are under the age of 18 years of age, do not report having a mobile phone, do not plan to reside in the New York City (NYC) metropolitan area for the following 12 months
- Children of parents who do not provide consent to participate.
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 |
|---|---|---|
| MySmileBuddy (MSB)Also: MSBThe technology-based MSB program equips community health workers (CHWs) with an iPad-based app that facilitates assessment of a child's early childhood caries (ECC). | Behavioural | MySmileBuddy |
Primary outcome
Change in Number of Decayed, Missing, or Filled Teeth or Surfaces
Time frame: 12 months post-randomization
Early childhood caries status will be determined by visual examination, assisted by an examination light, mirror, and probe with caries experience defined by number of teeth (t) and surfaces (s) that either have decay (d), are missing due to decay (m), or have had a dental filling (f) due to a cavity.
Proportion of Participants with Early Childhood Caries Progression
Time frame: 12 months post-randomization
The number of decayed, missing, or filled teeth (dmft)/decayed filled surfaces (dfs) as a count variable will be measured to determine the proportion of participants who have a positive change in the number of dmft/dfs post-intervention.
2 secondary outcomes
Change in Twice Daily Fluoridated Toothpaste Use
Time frame: 12 months post-randomization
Change in Consumption of a Low Cariogenic Diet
Time frame: 12 months post-randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Derived from this study: PubMed 33962602Lumsden CL, Edelstein BL, Basch CE, Wolf RL, Koch PA, McKeague I, Leu CS, Andrews H. Protocol for a family-centered behavioral intervention to reduce early childhood caries: the MySmileBuddy program efficacy trial. BMC Oral Health. 2021 May 7;21(1):246. doi: 10.1186/s12903-021-01582-4.
- 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.
Carol Kunzel, PhD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing MySmileBuddy (MSB) in people with Tooth Decay, run by Columbia University.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in Number of Decayed, Missing, or Filled Teeth or Surfaces (time frame: 12 months post-randomization). The study lists 2 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 NCT04845594, 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 15 Apr 2021.