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

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT01116739
• Collaborator: National Institute of Dental and Craniofacial Research (NIDCR) (NIH)
• Enrollment: 2,060
• Location: 1
• Arms: 2
• Actual Duration (Months): 92
• Patients Per Site Per Month: 22.4

Study Details

Study Description

Brief 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 children in American Indian Head Start Programs.

Condition or Disease	Intervention/Treatment	Phase
Fluoride Varnish and Oral Health Promotion; Usual Care	Device: Fluoride varnish; Behavioral: Oral health education; Other: Dental services delivered by the Indian Health Service.	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2060 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Preventing Caries in Preschoolers: Testing a Unique Service Delivery Model in American Indian Head Start Programs
• Actual Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: COHS administered fluoride varnish and oral health education 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.	Device: Fluoride varnish; Fluoride varnish will be administered by the COHS quarterly for 2 years.; Behavioral: Oral health education; 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.
Active Comparator: Usual care Usual care will include regular dental services provided by the Indian Health Service.	Other: Dental services delivered by the Indian Health Service.

Outcome Measures

Primary Outcome Measures

1. Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline [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.

2. Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1 [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.

3. Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2 [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.

4. Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3 [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.

Secondary Outcome Measures

1. Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children [Over 3 years]

   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.

2. Evaluation of Caries Patterns [Over 3 years]

   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.

3. Comparison of Utilization and Costs of Dental Care [Up to 3 years after randomization]

   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.

4. Acquisition of Dental Knowledge of the Caregivers of the Children [Over 3 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

• Principal Investigator: Patricia A Braun, MD MPH, University of Colorado, Denver

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 16, 2016

More Information

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. Erratum in: Contemp Clin Trials. 2014 May;38(1):155.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01116739
• Other Study ID Numbers: 08-0892; 1U54DE019259
• First Posted: May 5, 2010
• Last Update Posted: Jun 10, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Fluorides; Fluorides, Topical

Study Results

Participant Flow

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Period Title: Overall Study
STARTED	1056	1004
COMPLETED	926	868
NOT COMPLETED	130	136

Baseline Characteristics

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care	Total
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.	Total of all reporting groups
Overall Participants	926	868	1794
Age (Count of Participants)
<=18 years	463 50%	434 50%	897 50%
Between 18 and 65 years	463 50%	434 50%	897 50%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	621 67.1%	582 67.1%	1203 67.1%
Male	305 32.9%	286 32.9%	591 32.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	926 100%	868 100%	1794 100%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	926 100%	868 100%	1794 100%
Child Enrolled in a Head Start program in one of 53 centers on the Navajo Nation (Count of Participants)
Count of Participants [Participants]	926 100%	868 100%	1794 100%

Outcome Measures

1. Primary Outcome

Title	Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Baseline
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	443	424
Mean (Standard Deviation) [dmfs]	19.9 (20.1)	22.8 (20.1)

2. Primary Outcome

Title	Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 1
Description	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.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	217	231
Mean (Standard Deviation) [dmfs]	23.3 (20.4)	27.1 (21.5)

3. Primary Outcome

Title	Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 2
Description	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.
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	238	229
Mean (Standard Deviation) [dmfs]	28.5 (21.1)	31.2 (21.3)

4. Primary Outcome

Title	Evaluation of Decayed, Missing, and Filled Tooth Surfaces (Dmfs) at Year 3
Description	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.
Time Frame	3 Years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	118	111
Mean (Standard Deviation) [dmfs]	32.8 (22.3)	33.6 (18.6)

5. Secondary Outcome

Title	Acquisition of Dental Attitudes and Behaviors of the Caregivers of the Children
Description	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.
Time Frame	Over 3 years

Outcome Measure Data

Analysis Population Description

Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point.

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	463	434
Baseline	54.4 (19.3)	56.1 (18.3)
Year 1	62.7 (18.8)	58.2 (19.6)
Year 2	63.4 (18.7)	61.1 (18.3)
Year 3	65.6 (18.9)	66.4 (17.6)

6. Secondary Outcome

Title	Evaluation of Caries Patterns
Description	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.
Time Frame	Over 3 years

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	443	424
Baseline	86.5 9.3%	90.1 10.4%
Year 1	89.9 9.7%	90.9 10.5%
Year 2	95.4 10.3%	96.1 11.1%
Year 3	96.6 10.4%	98.2 11.3%

7. Secondary Outcome

Title	Comparison of Utilization and Costs of Dental Care
Description	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.
Time Frame	Up to 3 years after randomization

Outcome Measure Data

Analysis Population Description

Cost and utilization outcome measure data was not collected.

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	0	0

8. Secondary Outcome

Title	Acquisition of Dental Knowledge of the Caregivers of the Children
Description	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.
Time Frame	Over 3 years

Outcome Measure Data

Analysis Population Description

Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point.

Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education	Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.	Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
Measure Participants	463	434
Baseline	75.1 (30.7)	73.6 (13.1)
Year 1	80.4 (13.1)	76.8 (13.5)
Year 2	81.4 (14.8)	78.0 (13.2)
Year 3	81.2 (13.4)	79.5 (12.8)

Adverse Events

Time Frame	3 Years
Arm/Group Title	COHS Administered Fluoride Varnish and Oral Health Education		Usual Care
Arm/Group Description	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. Fluoride varnish: Fluoride varnish will be administered by the COHS quarterly for 2 years. Oral health education: 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.		Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service.
All Cause Mortality
	COHS Administered Fluoride Varnish and Oral Health Education		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/926 (0%)		0/868 (0%)
Serious Adverse Events
	COHS Administered Fluoride Varnish and Oral Health Education		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/926 (0%)		0/868 (0%)
Other (Not Including Serious) Adverse Events
	COHS Administered Fluoride Varnish and Oral Health Education		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/926 (0%)		0/868 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.