Dental CariesNCT01707797
Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings
An observational study of Dental Caries, run by University of Michigan at 3 sites in United States.
Trial summary
The study aims to develop a questionnaire that can be used to help uncover a child's risk of developing dental caries (also known as tooth decay or a cavity). The aim is to develop a practical and easily-scored risk tool that a primary medical care provider can use to help find young children with the highest risk for… Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 1,326 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Nov 2012to 30 Mar 2017
- Phase
- Observational
- 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 9 to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian.
Who may be able to join
- Adults
- If Primary Caregiver is the Parent/Legal guardian: The parent/legal guardian must provide written informed consent for the child and her/himself (if s/he is the primary caregiver) prior to participation.
- If Primary Caregiver is not the Parent/Legal Guardian: If another individual is the primary caregiver, then this individual must provide written informed consent for her/himself prior to participation.
- The parent/legal guardian and the participating primary caregiver must each be at least 18 years old or an emancipated minor
- The parent/legal guardian must consent and allow examination of the oral cavity of her/his child. The primary caregiver must complete the caries risk assessment questionnaire.
- The primary caregiver must be willing to participate, anticipate being the child's primary caregiver during the study period, and anticipate being available for all examinations (baseline, 18 month follow up, and 36 month follow up), in addition to intermediate contacts in between examinations.
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- Children
- Child must be 9-15 months of age at the time of the baseline study visit.
- Child must be generally healthy (i.e., no current medical condition that makes it difficult for her/him to receive a dental examination).
- Child must allow examination of the oral cavity.
Who cannot join
- Adults
- A participant pair (adult-child) who demonstrates an inability to comply with study protocol requirements will be excluded - this determination will be at the Site Primary Investigator's discretion.
- Non-English, non-Spanish reading/speaking individuals will be excluded, as they will not be able to comprehend the consent document or complete the risk questionnaire.
- Children
- Children who are in foster care at study initiation will be excluded, due to the likelihood that their primary caregiver will change multiple times during the length of the study.
- Need for antibiotic and/or sedative premedication prior to dental exam.
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- Uncontrolled epilepsy.
- Active cancer treatment.
- Unrepaired congenital heart defects that would require premedication prior to dental exam.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Health Center
Durham, North Carolina, 27704
Indiana University Oral Health Research Institute
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings A Stratified (by Race, Ethnicity, and Medicaid Status) Study to Develop a Caries Risk Prediction Questionnaire
The study aims to develop a questionnaire that can be used to help uncover a child's risk of developing dental caries (also known as tooth decay or a cavity). The aim is to develop a practical and easily-scored risk tool that a primary medical care provider can use to help find young children with the highest risk for developing cavities.
Read the detailed description
The duration of expected time to participate is 3 years (which includes 3 dental examinations).
- Conditions
- Dental Caries
- Keywords
- dental caries, high risk, dental cavities, children dental care
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy children aged 9-15 months | Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations
Outcomes will be defined at the participant level.
- Presence of any caries at baseline (defined as ICDAS ≥ 3, filling, or missing due to caries).
- Incidence (ICDAS ≥ 3, filling, or missing due to caries) and/or progression (change from ICDAS= 3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries) of any caries lesions at the follow-up examinations.
Measured: 3 years
Secondary outcomes (3)
Presence of any caries at baseline
Presence of any caries at baseline (defined as ICDAS > 0, which includes all early caries, filling, or missing due to caries). Presence of any caries at baseline (defined as ICDAS ≥ 5, which includes only frank cavitation, filling, or missing due to caries)
Measured: Baseline
Incidence and/or progression of any caries lesions at the follow-up examinations.
Incidence and/or progression of any caries lesions at the follow-up examinations. Progression is defined as change from ICDAS=0 to ICDAS=1 or higher, or filling, or missing due to caries; change from ICDAS=1 or 2 to ICDAS=3 or higher, or filling, or missing due to caries; or change from ICDAS=3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries.
Incidence of any caries lesions at the follow-up examinations. Because only distinct cavitation is included at baseline, no progression outcomes from baseline to follow-up will be defined.
Measured: 3 years
counts of the number of carious surfaces
- Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 3 to define decayed surfaces.
- Counts of the number of carious surfaces (dmfs), using ICDAS > 0 to define decayed surfaces.
- Counts of the number of carious surfaces (dmfs), using ICDAS ≥ 5 to define decayed surfaces
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study start15 Nov 2012
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,326 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Margherita Fontana, DDS, PhD, University of Michigan
- Investigators
- Margherita Fontana, DDS, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707797
- Sponsor's protocol ID
- NIDCR 11-101
- Other IDs
- U01DE021412-01A1
- Status last verified
- Sep 2018
- First submitted
- 12 Oct 2012
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fontana M, Eckert GJ, Keels MA, Jackson R, Katz BP, Kemper AR, Levy BT, Levy SM, Yanca E, Kelly S, Daly JM, Patterson B, McKnight P. Predicting Caries in Medical Settings: Risk Factors in Diverse Infant Groups. J Dent Res. 2019 Jan;98(1):68-76. doi: 10.1177/0022034518799080. Epub 2018 Sep 11.
PubMed 30205016Fontana M, Eckert GJ, Keels MA, Jackson R, Katz B, Levy BT, Levy SM. Fluoride Use in Health Care Settings: Association with Children's Caries Risk. Adv Dent Res. 2018 Feb;29(1):24-34. doi: 10.1177/0022034517735297.
PubMed 29355412
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Caries Risk in Underserved Toddlers in Primary Healthcare Settings A Stratified (by Race, Ethnicity, and Medicaid Status) Study to Develop a Caries Risk Prediction Questionnaire
- ClinicalTrials.gov ID
- NCT01707797
- Acronym / sponsor ID
- NIDCR 11-101
- Conditions
- Dental Caries
- Keywords
- dental caries, high risk, dental cavities, children dental care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,326 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 15 Nov 2012 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 16 Oct 2012 (estimated)
- 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 study aims to develop a questionnaire that can be used to help uncover a child's risk of developing dental caries (also known as tooth decay or a cavity). The aim is to develop a practical and easily-scored risk tool that a primary medical care provider can use to help find young children with the highest risk for developing cavities.
Detailed description
The duration of expected time to participate is 3 years (which includes 3 dental examinations).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy children aged 9-15 months | – | –Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian. |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy children aged 12 months (± 3 months) at baseline stratified by Medicaid status and/or race/ethnicity to ensure a diverse representation. Each child will be paired with the primary caregiver, whom the investigators expect to most likely be the adult parent or legal guardian.
Key inclusion criteria (10 listed)
- Adults
- If Primary Caregiver is the Parent/Legal guardian: The parent/legal guardian must provide written informed consent for the child and her/himself (if s/he is the primary caregiver) prior to participation.
- If Primary Caregiver is not the Parent/Legal Guardian: If another individual is the primary caregiver, then this individual must provide written informed consent for her/himself prior to participation.
- The parent/legal guardian and the participating primary caregiver must each be at least 18 years old or an emancipated minor
- The parent/legal guardian must consent and allow examination of the oral cavity of her/his child. The primary caregiver must complete the caries risk assessment questionnaire.
Key exclusion criteria (9 listed)
- Adults
- A participant pair (adult-child) who demonstrates an inability to comply with study protocol requirements will be excluded - this determination will be at the Site Primary Investigator's discretion.
- Non-English, non-Spanish reading/speaking individuals will be excluded, as they will not be able to comprehend the consent document or complete the risk questionnaire.
- Children
- Children who are in foster care at study initiation will be excluded, due to the likelihood that their primary caregiver will change multiple times during the length of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations
Time frame: 3 years
Outcomes will be defined at the participant level. 1. Presence of any caries at baseline (defined as ICDAS ≥ 3, filling, or missing due to caries). 2. Incidence (ICDAS ≥ 3, filling, or missing due to caries) and/or progression (change from ICDAS= 3 or 4 to ICDAS=5 or 6, or filling, or missing due to caries) of any caries lesions at the follow-up examinations.
3 secondary outcomes
Presence of any caries at baseline
Time frame: Baseline
Incidence and/or progression of any caries lesions at the follow-up examinations.
Time frame: 3 years
counts of the number of carious surfaces
Time frame: 3 years
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 17 Sep 2018.
- Derived from this study: PubMed 30205016Fontana M, Eckert GJ, Keels MA, Jackson R, Katz BP, Kemper AR, Levy BT, Levy SM, Yanca E, Kelly S, Daly JM, Patterson B, McKnight P. Predicting Caries in Medical Settings: Risk Factors in Diverse Infant Groups. J Dent Res. 2019 Jan;98(1):68-76. doi: 10.1177/0022034518799080. Epub 2018 Sep 11.
- Derived from this study: PubMed 29355412Fontana M, Eckert GJ, Keels MA, Jackson R, Katz B, Levy BT, Levy SM. Fluoride Use in Health Care Settings: Association with Children's Caries Risk. Adv Dent Res. 2018 Feb;29(1):24-34. doi: 10.1177/0022034517735297.
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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.
Margherita Fontana, DDS, PhD principal investigator
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Caries, run by University of Michigan at 3 sites 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 10 inclusion and 9 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 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Presence of any caries at baseline and incidence and/or progression of any caries lesions at follow up examinations (time frame: 3 years). 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 NCT01707797, which also lists 2 linked publications.
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 17 Sep 2018.