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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54DE019259 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | Active Comparator | Usual care will include regular dental services provided by the Indian Health Service. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride varnish | Device | Fluoride varnish will be administered by the COHS quarterly for 2 years. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 3 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia A Braun, MD MPH | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24469238 | Background | 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. | |
| 24961881 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 16, 2016 |
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| Oral health education | Behavioral | 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 |
|
| 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. | 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. | 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. | Over 3 years |
| 24954053 | Result | 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. |
| 25005885 | Result | 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. |
| 25101490 | Result | 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. |
| 25232515 | Result | 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. |
| 27439724 | Result | 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. |
| 31936256 | Derived | 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. |
| 28526003 | Derived | 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. |
| FG001 | Usual Care | Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service. |
| COMPLETED |
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| NOT COMPLETED |
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Baseline demographics data was collected for participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| BG001 | Usual Care | Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Child Enrolled in a Head Start program in one of 53 centers on the Navajo Nation | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only children, not parents, were analyzed for this outcome measure. | Posted | Mean | Standard Deviation | dmfs | Baseline |
|
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| ||||||||||||||||||||||||||||
| Primary | 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. | Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint. | Posted | Mean | Standard Deviation | dmfs | 1 Year |
| ||||||||||||||||||||||||||||||
| Primary | 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. | Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint. | Posted | Mean | Standard Deviation | dmfs | 2 Years |
| ||||||||||||||||||||||||||||||
| Primary | 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. | Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at this timepoint. | Posted | Mean | Standard Deviation | dmfs | 3 Years |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point. | Posted | Mean | Standard Deviation | score on a scale | Over 3 years |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Only children, not parents, were analyzed for this outcome measure. Some participants were unavailable for analysis at each timepoint. | Posted | Number | percentage of participants | Over 3 years |
| |||||||||||||||||||||||||||||||
| Secondary | 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. | Cost and utilization outcome measure data was not collected. | Posted | Up to 3 years after randomization |
|
| ||||||||||||||||||||||||||||||||
| Secondary | 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. | Only the caregivers, not the children, were analyzed for this outcome measure. Not all participants were available for analysis at every time point. | Posted | Mean | Standard Deviation | score on a scale | Over 3 years |
|
3 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. | 0 | 926 | 0 | 926 | 0 | 926 |
| EG001 | Usual Care | Usual care will include regular dental services provided by the Indian Health Service. Dental services delivered by the Indian Health Service. | 0 | 868 | 0 | 868 | 0 | 868 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia A. Braun | University of Colorado Denver | 3037241111 | clinicalresearchsupportcenter@ucdenver.edu |
| May 12, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006267 | Health Education, Dental |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011636 | Public Health Dentistry |
| D004778 | Environment and Public Health |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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