CariesNCT00793507
Oral Health Care Early Intervention Project
A study testing Oral Health Care Early Intervention Project in people with Caries, run by University of Colorado, Denver at 5 sites in United States.
Trial summary
This pilot project consists of co-locating dental hygienist services in medical primary care offices. Dental hygienists will work in close collaboration with the primary care offices, providing preventive dental care to young children either before or after scheduled well-child visits. Read more about this study
- Who is it for?
- Ages Up to 36 months
- Conditions the study is for
- Caries
- What is being tested?
- Oral Health Care Early Intervention Project
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,178 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2008to Apr 2011
- 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 Up to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with the following characteristics will be included in the study:
- 0 - 36 months;
- Have at least one tooth;
- Have had one or more visits to a study practice in the prior 18 months.
Who cannot join
- Children with the following characteristics will be excluded from the study:
- No teeth; in essence child has not had any teeth erupt yet;
- Chronic medical condition affecting oral health or the ability to perform routine preventive dental care, such as cerebral palsy, mental retardation, ectodermal dysplasia, and other genetic syndromes affecting oral health
- Reports receiving primary health care somewhere else other than at one of the study practices;
- Parents < 18 years of age.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Rocky Mountain Youth
Aurora, Colorado, 80011
Grand Mesa Dental Hygiene, LLC
Delta, Colorado, 81416
Salud Family Health Centers
Fort Collins, Colorado, 80524
The Pediatric Associates
Montrose, Colorado, 81401
Rocky Mountain Youth
Thornton, Colorado, 80229
About this study
This pilot project consists of co-locating dental hygienist services in medical primary care offices. Dental hygienists will work in close collaboration with the primary care offices, providing preventive dental care to young children either before or after scheduled well-child visits.
Read the detailed description
This investigation is designed to determine the effect of having co-located dental hygienists in primary care offices on the incidence of early childhood caries among young children seen at these primary care offices. The dental hygienists will provide routine preventive dental care and oral health education within the usual scope of their practice. The study is also designed to assess parent knowledge, attitudes, and beliefs about oral health and perceived barriers to preventive dental care, as well as how their oral health-related attitudes change over time.
The specific aims for this project are:
Specific Aim 1: Among parents of young children seen in pediatric and family medicine primary care practices, determine the knowledge, attitudes, and beliefs of parents regarding the importance of oral health, means of preventing caries, and perceived barriers to accessing regular preventive dental care.
Specific Aim 2: After co-locating dental hygienists within pediatric and family medicine primary care practices, determine by randomized controlled trial the effect of routine preventive dental care provided by dental hygienists on the incidence of early childhood caries.
Specific Aim 3: Among parents of young children seen in pediatric and family medicine primary care practices, determine how parental oral health-related knowledge, attitudes, beliefs, and perceived barriers change over time, among parents of children seen by a co-located dental hygienist.
The major hypotheses for this project are:
- Parents of children with public health insurance (Medicaid or Child Health Plan-Plus) will have one-half the odds of reporting a usual source of preventive dental care compared to children with private health insurance.
- Among young children receiving routine preventive dental care by a co-located dental hygienist, 10% will develop dental caries over a 24-month period, compared with 20% caries experience among children who do not receive routine preventive dental care by a co-located dental hygienist.
- Parents of children with early childhood caries (any caries in a primary tooth) which developed over a 24-month period will have more than twice the odds of reporting barriers to accessing a dental provider than parents of children with no early childhood caries.
- Conditions
- Caries
- Being tested
- Oral Health Care Early Intervention Project
- Keywords
- childhood caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Health Care Early Intervention ProjectOther
The intervention group will receive routine preventive dental care, 2 to 4 times per year depending on risk of caries. The intervention group will also receive pre-scheduling, reminders, and care coordination by the dental hygienist. The control group will receive usual care, but will not receive pre-scheduling, reminders, or care coordination by the dental hygienist. In order to determine the incidence of early childhood caries at study enrollment, both intervention and control groups will receive a standardized oral examination with an assessment of caries presence and extent on the day of enrollment, at 12 months and at 24 months after enrollment. Both children in the control group and intervention group will be referred to a dentist if found to need restorative care.
| Study group | Role | What they receive |
|---|---|---|
| 1: Intervention Group | Experimental | All participants in the intervention group will be receiving standard preventive dental care received by children in their dental providers' office. These intervention children will receive dental scaling, cleaning and fluoride varnish at visits every three to six months. All participants in the intervention group will receive active reminder/recall from the hygienist, encouraging the participants to return every three to six months for the oral exam, cleaning, scaling and fluoride application. Receives: Other: Oral Health Care Early Intervention Project |
| 2: Control Group | Active comparator | The control group will receive usual care, but will not receive pre-scheduling, reminders, or care coordination by the dental hygienist. Receives: Other: Oral Health Care Early Intervention Project |
What is being measured
The primary outcome is the main question the study is designed to answer.
New ECC*(presence/absence)
Measured: At end of study, 24 months
Secondary outcomes (4)
Association of ECC with perceived barriers to accessing a dental provider.
Measured: Day 1 of entry into study
Changes in parental knowledge, attitude, beliefs and barriers from pre- to post-study
Measured: At end of study, 24 months
Frequencies of parental knowledge, attitudes, beliefs and barriers (Descriptive variables: scales constructed of 4-point Likert items
Measured: Day 1 of entry into study
Severity of caries( presence/absence of S-ECC)
Measured: At end of study, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for CariesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Masking
- None (open label)
- Enrolment
- 1,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Delta Dental Foundation
- Responsible party
- Sponsor
- Investigators
- Matthew F. Daley, MD, Principal investigator, University of Colorado, DenverPatricia Braun, MD, Study director, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793507
- Sponsor's protocol ID
- 07-0198
- Other IDs
- PN200703-001
- Status last verified
- Jan 2009
- First submitted
- 17 Nov 2008
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Beltran-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43.
PubMed 16121123U.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. 1-332. 2000. Rockville, MD, U.S. Department of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes of Health. Ref Type: Report
Yu SM, Bellamy HA, Kogan MD, Dunbar JL, Schwalberg RH, Schuster MA. Factors that influence receipt of recommended preventive pediatric health and dental care. Pediatrics. 2002 Dec;110(6):e73. doi: 10.1542/peds.110.6.e73.
PubMed 12456940Kenney GM, McFeeters JR, Yee JY. Preventive dental care and unmet dental needs among low-income children. Am J Public Health. 2005 Aug;95(8):1360-6. doi: 10.2105/AJPH.2004.056523.
PubMed 16043667Liu J, Probst JC, Martin AB, Wang JY, Salinas CF. Disparities in dental insurance coverage and dental care among US children: the National Survey of Children's Health. Pediatrics. 2007 Feb;119 Suppl 1:S12-21. doi: 10.1542/peds.2006-2089D.
PubMed 17272579Edelstein BL. Disparities in oral health and access to care: findings of national surveys. Ambul Pediatr. 2002 Mar-Apr;2(2 Suppl):141-7. doi: 10.1367/1539-4409(2002)0022.0.co;2.
PubMed 11950385Lewis CW, Johnston BD, Linsenmeyar KA, Williams A, Mouradian W. Preventive dental care for children in the United States: a national perspective. Pediatrics. 2007 Mar;119(3):e544-53. doi: 10.1542/peds.2006-1958.
PubMed 17332174dela Cruz GG, Rozier RG, Slade G. Dental screening and referral of young children by pediatric primary care providers. Pediatrics. 2004 Nov;114(5):e642-52. doi: 10.1542/peds.2004-1269.
PubMed 15520094Lewis CW, Grossman DC, Domoto PK, Deyo RA. The role of the pediatrician in the oral health of children: A national survey. Pediatrics. 2000 Dec;106(6):E84. doi: 10.1542/peds.106.6.e84.
PubMed 11099627Mofidi M, Rozier RG, King RS. Problems with access to dental care for Medicaid-insured children: what caregivers think. Am J Public Health. 2002 Jan;92(1):53-8. doi: 10.2105/ajph.92.1.53.
PubMed 11772761Siegal MD, Marx ML, Cole SL. Parent or caregiver, staff, and dentist perspectives on access to dental care issues for head start children in Ohio. Am J Public Health. 2005 Aug;95(8):1352-9. doi: 10.2105/AJPH.2004.054858. Epub 2005 Jul 7.
PubMed 16006416Kelly SE, Binkley CJ, Neace WP, Gale BS. Barriers to care-seeking for children's oral health among low-income caregivers. Am J Public Health. 2005 Aug;95(8):1345-51. doi: 10.2105/AJPH.2004.045286.
PubMed 16043666Finlayson TL, Siefert K, Ismail AI, Delva J, Sohn W. Reliability and validity of brief measures of oral health-related knowledge, fatalism, and self-efficacy in mothers of African American children. Pediatr Dent. 2005 Sep-Oct;27(5):422-8.
PubMed 16435644American Academy of Pediatric Dentistry; American Academy of Pediatrics; American Academy of Pediatric Dentistry Council on Clinical Affairs. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2005-2006;27(7 Suppl):31-3. No abstract available.
PubMed 16541878Truman BI, Gooch BF, Sulemana I, Gift HC, Horowitz AM, Evans CA, Griffin SO, Carande-Kulis VG; Task Force on Community Preventive Services. Reviews of evidence on interventions to prevent dental caries, oral and pharyngeal cancers, and sports-related craniofacial injuries. Am J Prev Med. 2002 Jul;23(1 Suppl):21-54. doi: 10.1016/s0749-3797(02)00449-x.
PubMed 12091093
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Health Care Early Intervention Project
- ClinicalTrials.gov ID
- NCT00793507
- Acronym / sponsor ID
- 07-0198
- Conditions
- Caries
- Keywords
- childhood caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,178 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Delta Dental Foundation
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Nov 2008 (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.
This pilot project consists of co-locating dental hygienist services in medical primary care offices. Dental hygienists will work in close collaboration with the primary care offices, providing preventive dental care to young children either before or after scheduled well-child visits.
Detailed description
This investigation is designed to determine the effect of having co-located dental hygienists in primary care offices on the incidence of early childhood caries among young children seen at these primary care offices. The dental hygienists will provide routine preventive dental care and oral health education within the usual scope of their practice. The study is also designed to assess parent knowledge, attitudes, and beliefs about oral health and perceived barriers to preventive dental care, as well as how their oral health-related attitudes change over time.
The specific aims for this project are:
Specific Aim 1: Among parents of young children seen in pediatric and family medicine primary care practices, determine the knowledge, attitudes, and beliefs of parents regarding the importance of oral health, means of preventing caries, and perceived barriers to accessing regular preventive dental care.
Specific Aim 2: After co-locating dental hygienists within pediatric and family medicine primary care practices, determine by randomized controlled trial the effect of routine preventive dental care provided by dental hygienists on the incidence of early childhood caries.
Specific Aim 3: Among parents of young children seen in pediatric and family medicine primary care practices, determine how parental oral health-related knowledge, attitudes, beliefs, and perceived barriers change over time, among parents of children seen by a co-located dental hygienist.
The major hypotheses for this project are:
- Parents of children with public health insurance (Medicaid or Child Health Plan-Plus) will have one-half the odds of reporting a usual source of preventive dental care compared to children with private health insurance.
- Among young children receiving routine preventive dental care by a co-located dental hygienist, 10% will develop dental caries over a 24-month period, compared with 20% caries experience among children who do not receive routine preventive dental care by a co-located dental hygienist.
- Parents of children with early childhood caries (any caries in a primary tooth) which developed over a 24-month period will have more than twice the odds of reporting barriers to accessing a dental provider than parents of children with no early childhood caries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Intervention Group | Experimental | Other: Oral Health Care Early Intervention ProjectAll participants in the intervention group will be receiving standard preventive dental care received by children in their dental providers' office. These intervention children will receive dental scaling, cleaning and fluoride varnish at visits every three to six months. All participants in the intervention group will receive active reminder/recall from the hygienist, encouraging the participants to return every three to six months for the oral exam, cleaning, scaling and fluoride application. |
| 2: Control Group | Active comparator | Other: Oral Health Care Early Intervention ProjectThe control group will receive usual care, but will not receive pre-scheduling, reminders, or care coordination by the dental hygienist. |
Who may qualify
- Ages
- Up to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 0 - 36 months;
- Have at least one tooth;
- Have had one or more visits to a study practice in the prior 18 months.
Key exclusion criteria (5 listed)
- No teeth; in essence child has not had any teeth erupt yet;
- Chronic medical condition affecting oral health or the ability to perform routine preventive dental care, such as cerebral palsy, mental retardation, ectodermal dysplasia, and other genetic syndromes affecting oral health
- Reports receiving primary health care somewhere else other than at one of the study practices;
- Parents < 18 years of age.
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 |
|---|---|---|
| Oral Health Care Early Intervention ProjectThe intervention group will receive routine preventive dental care, 2 to 4 times per year depending on risk of caries. The intervention group will also receive pre-scheduling, reminders, and care coordination by the dental hygienist. The control group will receive usual care, but will not receive pre-scheduling, reminders, or care coordination by the dental hygienist. In order to determine the incidence of early childhood caries at study enrollment, both intervention and control groups will receive a standardized oral examination with an assessment of caries presence and extent on the day of enrollment, at 12 months and at 24 months after enrollment. Both children in the control group and intervention group will be referred to a dentist if found to need restorative care. | Other | 1: Intervention Group, 2: Control Group |
Primary outcome
New ECC*(presence/absence)
Time frame: At end of study, 24 months
4 secondary outcomes
Association of ECC with perceived barriers to accessing a dental provider.
Time frame: Day 1 of entry into study
Changes in parental knowledge, attitude, beliefs and barriers from pre- to post-study
Time frame: At end of study, 24 months
Frequencies of parental knowledge, attitudes, beliefs and barriers (Descriptive variables: scales constructed of 4-point Likert items
Time frame: Day 1 of entry into study
Severity of caries( presence/absence of S-ECC)
Time frame: At end of study, 24 months
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 5 Feb 2013.
- Background: PubMed 16121123Beltran-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43.
- BackgroundU.S. Department of Health and Human Services. Oral Health in America: A Report of the Surgeon General. 1-332. 2000. Rockville, MD, U.S. Department of Health and Human Services, National Institute of Dental and Craniofacial Research, National Institutes of Health. Ref Type: Report
- Background: PubMed 12456940Yu SM, Bellamy HA, Kogan MD, Dunbar JL, Schwalberg RH, Schuster MA. Factors that influence receipt of recommended preventive pediatric health and dental care. Pediatrics. 2002 Dec;110(6):e73. doi: 10.1542/peds.110.6.e73.
- Background: PubMed 16043667Kenney GM, McFeeters JR, Yee JY. Preventive dental care and unmet dental needs among low-income children. Am J Public Health. 2005 Aug;95(8):1360-6. doi: 10.2105/AJPH.2004.056523.
- Background: PubMed 17272579Liu J, Probst JC, Martin AB, Wang JY, Salinas CF. Disparities in dental insurance coverage and dental care among US children: the National Survey of Children's Health. Pediatrics. 2007 Feb;119 Suppl 1:S12-21. doi: 10.1542/peds.2006-2089D.
- Background: PubMed 11950385Edelstein BL. Disparities in oral health and access to care: findings of national surveys. Ambul Pediatr. 2002 Mar-Apr;2(2 Suppl):141-7. doi: 10.1367/1539-4409(2002)0022.0.co;2.
- Background: PubMed 17332174Lewis CW, Johnston BD, Linsenmeyar KA, Williams A, Mouradian W. Preventive dental care for children in the United States: a national perspective. Pediatrics. 2007 Mar;119(3):e544-53. doi: 10.1542/peds.2006-1958.
- Background: PubMed 15520094dela Cruz GG, Rozier RG, Slade G. Dental screening and referral of young children by pediatric primary care providers. Pediatrics. 2004 Nov;114(5):e642-52. doi: 10.1542/peds.2004-1269.
- Background: PubMed 11099627Lewis CW, Grossman DC, Domoto PK, Deyo RA. The role of the pediatrician in the oral health of children: A national survey. Pediatrics. 2000 Dec;106(6):E84. doi: 10.1542/peds.106.6.e84.
- Background: PubMed 11772761Mofidi M, Rozier RG, King RS. Problems with access to dental care for Medicaid-insured children: what caregivers think. Am J Public Health. 2002 Jan;92(1):53-8. doi: 10.2105/ajph.92.1.53.
- Background: PubMed 16006416Siegal MD, Marx ML, Cole SL. Parent or caregiver, staff, and dentist perspectives on access to dental care issues for head start children in Ohio. Am J Public Health. 2005 Aug;95(8):1352-9. doi: 10.2105/AJPH.2004.054858. Epub 2005 Jul 7.
- Background: PubMed 16043666Kelly SE, Binkley CJ, Neace WP, Gale BS. Barriers to care-seeking for children's oral health among low-income caregivers. Am J Public Health. 2005 Aug;95(8):1345-51. doi: 10.2105/AJPH.2004.045286.
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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.
Matthew F. Daley, MD principal investigator
University of Colorado, Denver
Patricia Braun, MD study director
University of Colorado, Denver
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Health Care Early Intervention Project in people with Caries, run by University of Colorado, Denver at 5 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 4 inclusion and 5 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 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
New ECC*(presence/absence) (time frame: At end of study, 24 months). 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 NCT00793507, which also lists 15 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 5 Feb 2013.