Fluoride Varnish and Oral Health PromotionPhase 3NCT01116739

Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs

A Phase 3 study testing Fluoride varnish, Oral health education and Dental services delivered by the Indian Health Service. in people with Fluoride Varnish and Oral Health Promotion and Usual Care, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

An intensive intervention of specially trained paraprofessionals, called community oral health specialists (COHS), administering on a quarterly basis for 2 years fluoride varnish and oral health promotion education, compared to usual care, will reduce decayed, missing, and filled tooth surface measures at 2 years for… Read more about this study

Who is it for?: Ages 3 to 5 yearsHealthy volunteers can take part
Conditions the study is for: Fluoride Varnish and Oral Health Promotion, Usual Care
What is being tested?: Fluoride varnish, Oral health education and Dental services delivered by the Indian Health Service.
Type of treatment: Pill or oral medicine, Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,060 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Dec 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 3 to 5 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and having a primary caregiver (preferably mother, or the child's legal guardian as documented by the HSC)
American Indian, as defined by the tribe, or
Children of other racial/ethnic groups who are in the Head Start classes on the Reservation
Parent/caregiver able to read, understand, and sign the study consent form, and
Willing and able to follow the study procedures and instructions

Who cannot join

Allergy to any of the components of the fluoride varnish
Ulcerative gingivitis
Stomatitis
Other conditions resulting in disrupted or irritated oral mucosa
Any other conditions or findings that, in the opinion of the investigators, would interfere with or preclude participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Colorado
Aurora, Colorado, 80045

Other trials in United States

About this study

Read the detailed description

The study design will be a clustered randomized design. Fifty-two head start classes in a Southwest American Indian Reservation will be randomized, 26 to the intervention program and 26 to usual care. The intervention will be comprised of specially trained paraprofessionals, called community oral health specialists (COHS), administering fluoride varnish and oral health promotion education quarterly for 2 years. Baseline and annual measures of decayed, missing, and filled tooth surfaces (dmfs) of the children, and surveys of their caregivers' dental knowledge, attitudes, and behaviors will be completed. The study will be a 5-year study, with 2 years for intake/accrual, and 3 years of follow-up.

Conditions: Fluoride Varnish and Oral Health Promotion, Usual Care
Being tested: Fluoride varnish, Oral health education, Dental services delivered by the Indian Health Service.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fluoride varnishDevice
Fluoride varnish will be administered by the COHS quarterly for 2 years.
Oral health educationBehavioural
Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
Dental services delivered by the Indian Health Service.Other

Study groups in NCT01116739
Study group	Role	What they receive
COHS administered fluoride varnish and oral health education	Experimental	Paraprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years. Receives: Device: Fluoride varnish; Behavioral: Oral health education
Usual care	Active comparator	Usual care will include regular dental services provided by the Indian Health Service. Receives: Other: Dental services delivered by the Indian Health Service.

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Measured: Baseline
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Measured: 1 Year
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Measured: 2 Years
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Measured: 3 Years

Secondary outcomes (4)

Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing attitudes and behaviors is comprised of 12 items. Scores are calculated as a percentage of appropriate responses. Therefore, possible scores range from 0-100.
Measured: Over 3 years
Evaluation of Caries Patterns
Caries patterns will be studied in terms of the specific teeth and tooth surfaces that are affected. Caries prevalence is defined as the presence of more than 0 dmfs (decayed, missing, or filled surfaces) in the child participant. The percentage of child participants with caries prevalence is reported.
Measured: Over 3 years
Comparison of Utilization and Costs of Dental Care
Utilization and costs of dental care received by the children in the study will be compared, as well as the costs of the intervention program.
Measured: Up to 3 years after randomization
Acquisition of Dental Knowledge of the Caregivers of the Children
An automated computer assisted survey interview (ACASI)will be done of the caregivers of the children. The questions have been standardized across 6 studies from the Collaborating Research Centers to Reduce Oral Health Disparities. The survey assessing knowledge is comprised of 14 items. Scores are calculated as a percentage of correct answers. Therefore, possible scores range from 0-100.
Measured: Over 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2018

First posted5 May 2010 (estimated)
Study startApr 2011
Primary completionDec 2018
Study completionDec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Fluoride Varnish and Oral Health PromotionStudies 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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 2,060 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01116739
Sponsor's protocol ID: 08-0892
Other IDs: 1U54DE019259
Status last verified: May 2021
First submitted: 3 May 2010
Last updated: 10 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Quissell DO, Bryant LL, Braun PA, Cudeii D, Johs N, Smith VL, George C, Henderson WG, Albino J. Preventing caries in preschoolers: successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start. Contemp Clin Trials. 2014 Mar;37(2):242-51. doi: 10.1016/j.cct.2014.01.004. Epub 2014 Jan 25.
PubMed 24469238
Albino J, Tiwari T, Henderson WG, Thomas J, Bryant LL, Batliner TS, Braun PA, Wilson A, Quissell DO. Learning from caries-free children in a high-caries American Indian population. J Public Health Dent. 2014 Fall;74(4):293-300. doi: 10.1111/jphd.12058. Epub 2014 Jun 24.
PubMed 24961881
Batliner T, Wilson AR, Tiwari T, Glueck D, Henderson W, Thomas J, Braun P, Cudeii D, Quissell D, Albino J. Oral health status in Navajo Nation Head Start children. J Public Health Dent. 2014 Fall;74(4):317-25. doi: 10.1111/jphd.12061. Epub 2014 Jun 23.
PubMed 24954053
Braun PA, Lind KE, Henderson WG, Brega AG, Quissell DO, Albino J. Validation of a pediatric oral health-related quality of life scale in Navajo children. Qual Life Res. 2015 Jan;24(1):231-9. doi: 10.1007/s11136-014-0751-3. Epub 2014 Jul 9.
PubMed 25005885
Tiwari T, Casciello A, Gansky SA, Henshaw M, Ramos-Gomez F, Rasmussen M, Garcia RI, Albino J, Batliner TS; Early Childhood Caries Collaborating Centers. Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers. Prev Chronic Dis. 2014 Aug 7;11:E133. doi: 10.5888/pcd11.140140.
PubMed 25101490
Tiwari T, Quissell DO, Henderson WG, Thomas JF, Bryant LL, Braun PA, Albino JE. Factors Associated with Oral Health Status in American Indian Children. J Racial Ethn Health Disparities. 2014 Sep 1;1(3):148-156. doi: 10.1007/s40615-014-0017-3.
PubMed 25232515
Braun PA, Quissell DO, Henderson WG, Bryant LL, Gregorich SE, George C, Toledo N, Cudeii D, Smith V, Johs N, Cheng J, Rasmussen M, Cheng NF, Santo W, Batliner T, Wilson A, Brega A, Roan R, Lind K, Tiwari T, Shain S, Schaffer G, Harper M, Manson SM, Albino J. A Cluster-Randomized, Community-Based, Tribally Delivered Oral Health Promotion Trial in Navajo Head Start Children. J Dent Res. 2016 Oct;95(11):1237-44. doi: 10.1177/0022034516658612. Epub 2016 Jul 20.
PubMed 27439724
Wilson AR, Tiwari T, Thomas JF, Henderson WG, Braun PA, Albino J. Validation of Psychosocial Measures Assessing American Indian Parental Beliefs Related to Control over Their Children's Oral Health. Int J Environ Res Public Health. 2020 Jan 8;17(2):403. doi: 10.3390/ijerph17020403.
PubMed 31936256
Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.
PubMed 28526003

Study at a glance

From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
ClinicalTrials.gov ID: NCT01116739
Acronym / sponsor ID: 08-0892
Conditions: Fluoride Varnish and Oral Health Promotion, Usual Care
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,060 participants (actual)
Lead sponsor: University of Colorado, DenverUniversity, hospital or other
Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Study start: Apr 2011 (actual)
Primary completion: Dec 2018 (actual)
Study completion: Dec 2018 (actual)
First posted: 5 May 2010 (estimated)
Results: Posted 10 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
COHS administered fluoride varnish and oral health education	Experimental	Device: Fluoride varnish, Behavioral: Oral health educationParaprofessionals, called community oral health specialists (COHS), will be trained to administer fluoride varnish and oral health education to head start children quarterly for 2 years.
Usual care	Active comparator	Other: Dental services delivered by the Indian Health Service.Usual care will include regular dental services provided by the Indian Health Service.

Who may qualify

Ages: 3 to 5 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Children ages 3-5 enrolled in Head Start Centers on a Southwest Indian Reservation and having a primary caregiver (preferably mother, or the child's legal guardian as documented by the HSC)
American Indian, as defined by the tribe, or
Children of other racial/ethnic groups who are in the Head Start classes on the Reservation
Parent/caregiver able to read, understand, and sign the study consent form, and
Willing and able to follow the study procedures and instructions

Key exclusion criteria (5 listed)

Allergy to any of the components of the fluoride varnish
Ulcerative gingivitis
Stomatitis
Other conditions resulting in disrupted or irritated oral mucosa
Any other conditions or findings that, in the opinion of the investigators, would interfere with or preclude participation in 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.

Interventions

Intervention	Type	Arms
Fluoride varnishFluoride varnish will be administered by the COHS quarterly for 2 years.	Device	COHS administered fluoride varnish and oral health education
Oral health educationOral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.	Behavioural	COHS administered fluoride varnish and oral health education
Dental services delivered by the Indian Health Service.	Other	Usual care

Primary outcome

Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
Time frame: Baseline
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
Time frame: 1 Year
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
Time frame: 2 Years
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.
Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
Time frame: 3 Years
The number of decayed, missing, and filled tooth surfaces (dmfs) for each child. The dental examiners will be trained and calibrated, and standardized criteria and instruments will be used for the detection of the dental caries.

4 secondary outcomes

Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
Time frame: Over 3 years
Evaluation of Caries Patterns
Time frame: Over 3 years
Comparison of Utilization and Costs of Dental Care
Time frame: Up to 3 years after randomization
Acquisition of Dental Knowledge of the Caregivers of the Children
Time frame: Over 3 years

Results and safety

Results posted to the registry on 10 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
COHS Administered Fluoride Varnish and Oral Health Education	1,056	926
Usual Care	1,004	868

Primary outcome: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: dmfs

Measure	COHS Administered Fluoride Varnish and Oral Health Education n = 443	Usual Care n = 424
Value	19.9 (20.1)	22.8 (20.1)

Population analysed: Only children, not parents, were analyzed for this outcome measure.

Primary outcome: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1

Time frame: 1 Year. Mean (Standard Deviation). Unit: dmfs

Measure	COHS Administered Fluoride Varnish and Oral Health Education n = 217	Usual Care n = 231
Value	23.3 (20.4)	27.1 (21.5)

Population analysed: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.

Primary outcome: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2

Time frame: 2 Years. Mean (Standard Deviation). Unit: dmfs

Measure	COHS Administered Fluoride Varnish and Oral Health Education n = 238	Usual Care n = 229
Value	28.5 (21.1)	31.2 (21.3)

Population analysed: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.

Primary outcome: Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3

Time frame: 3 Years. Mean (Standard Deviation). Unit: dmfs

Measure	COHS Administered Fluoride Varnish and Oral Health Education n = 118	Usual Care n = 111
Value	32.8 (22.3)	33.6 (18.6)

Population analysed: Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
COHS Administered Fluoride Varnish and Oral Health Education	0 of 926 (0%)	0 of 926 (0%)	0 of 926
Usual Care	0 of 868 (0%)	0 of 868 (0%)	0 of 868

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24469238Quissell DO, Bryant LL, Braun PA, Cudeii D, Johs N, Smith VL, George C, Henderson WG, Albino J. Preventing caries in preschoolers: successful initiation of an innovative community-based clinical trial in Navajo Nation Head Start. Contemp Clin Trials. 2014 Mar;37(2):242-51. doi: 10.1016/j.cct.2014.01.004. Epub 2014 Jan 25.
Results publication: PubMed 24961881Albino J, Tiwari T, Henderson WG, Thomas J, Bryant LL, Batliner TS, Braun PA, Wilson A, Quissell DO. Learning from caries-free children in a high-caries American Indian population. J Public Health Dent. 2014 Fall;74(4):293-300. doi: 10.1111/jphd.12058. Epub 2014 Jun 24.
Results publication: PubMed 24954053Batliner T, Wilson AR, Tiwari T, Glueck D, Henderson W, Thomas J, Braun P, Cudeii D, Quissell D, Albino J. Oral health status in Navajo Nation Head Start children. J Public Health Dent. 2014 Fall;74(4):317-25. doi: 10.1111/jphd.12061. Epub 2014 Jun 23.
Results publication: PubMed 25005885Braun PA, Lind KE, Henderson WG, Brega AG, Quissell DO, Albino J. Validation of a pediatric oral health-related quality of life scale in Navajo children. Qual Life Res. 2015 Jan;24(1):231-9. doi: 10.1007/s11136-014-0751-3. Epub 2014 Jul 9.
Results publication: PubMed 25101490Tiwari T, Casciello A, Gansky SA, Henshaw M, Ramos-Gomez F, Rasmussen M, Garcia RI, Albino J, Batliner TS; Early Childhood Caries Collaborating Centers. Recruitment for health disparities preventive intervention trials: the early childhood caries collaborating centers. Prev Chronic Dis. 2014 Aug 7;11:E133. doi: 10.5888/pcd11.140140.
Results publication: PubMed 25232515Tiwari T, Quissell DO, Henderson WG, Thomas JF, Bryant LL, Braun PA, Albino JE. Factors Associated with Oral Health Status in American Indian Children. J Racial Ethn Health Disparities. 2014 Sep 1;1(3):148-156. doi: 10.1007/s40615-014-0017-3.
Results publication: PubMed 27439724Braun PA, Quissell DO, Henderson WG, Bryant LL, Gregorich SE, George C, Toledo N, Cudeii D, Smith V, Johs N, Cheng J, Rasmussen M, Cheng NF, Santo W, Batliner T, Wilson A, Brega A, Roan R, Lind K, Tiwari T, Shain S, Schaffer G, Harper M, Manson SM, Albino J. A Cluster-Randomized, Community-Based, Tribally Delivered Oral Health Promotion Trial in Navajo Head Start Children. J Dent Res. 2016 Oct;95(11):1237-44. doi: 10.1177/0022034516658612. Epub 2016 Jul 20.
Derived from this study: PubMed 31936256Wilson AR, Tiwari T, Thomas JF, Henderson WG, Braun PA, Albino J. Validation of Psychosocial Measures Assessing American Indian Parental Beliefs Related to Control over Their Children's Oral Health. Int J Environ Res Public Health. 2020 Jan 8;17(2):403. doi: 10.3390/ijerph17020403.
Derived from this study: PubMed 28526003Albino J, Tiwari T, Gansky SA, Henshaw MM, Barker JC, Brega AG, Gregorich SE, Heaton B, Batliner TS, Borrelli B, Geltman P, Kressin NR, Weintraub JA, Finlayson TL, Garcia RI; Early Childhood Caries Collaborating Centers. The basic research factors questionnaire for studying early childhood caries. BMC Oral Health. 2017 May 19;17(1):83. doi: 10.1186/s12903-017-0374-5.

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.

Patricia A Braun, MD MPH principal investigator

University of Colorado, Denver

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 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 10 Jun 2021. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline (time frame: Baseline). 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 NCT01116739, which also lists 9 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 10 Jun 2021.