Trial Outcomes & Findings for Providers Against Cavities in Children's Teeth (NCT NCT03385629)

Last Updated: 2025-04-17

Results Overview

Receipt of any dental care (preventive and/or restorative) at approximately 24 months from baseline to the exit visit. Any dental care was defined as yes or no visit.

Recruitment status

COMPLETED

Study phase

Target enrollment

2108 participants

Primary outcome timeframe

Data will be abstracted from Clinical Exams and Medicaid Claims data at baseline and the exit visit at the 24 month follow-up visit.

Results posted on

2025-04-17

Participant Flow

This study included 18 primary care practices in northeast Ohio randomized into 1 of 2 arms using a restricted randomization scheme with 9 practices assigned to each arm. Providers and parent-child dyads were participants assigned to groups based on affiliated practice. 63 Providers and 1024 parent-child dyads were recruited between 11/2017 and 8/2019. 1 provider, 1 parent-child dyad were late exclusions, leaving 2108 individuals enrolled (62 providers, 1023 parent/caregivers \& 1023 children).

Unit of analysis: Practices

Participant milestones

Participant milestones
Measure	CSM Theory-based Arm 1. CSM theory-based didactic education and skills training for providers CSM theory-based didactic education and practical skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and how to document the oral health encounter in EMR. 2. Practice EMR changes w/oral health questions Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm AAP-based didactic education (without theory-based training, skills training or EMR changes) AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
Baseline Well Child Visit 1 STARTED	1061 9	1047 9
Baseline Well Child Visit 1 COMPLETED	1061 9	1047 9
Baseline Well Child Visit 1 NOT COMPLETED	0 0	0 0
Follow-up Well Child Visit 2 STARTED	1035 9	1023 9
Follow-up Well Child Visit 2 COMPLETED	815 9	860 9
Follow-up Well Child Visit 2 NOT COMPLETED	220 0	163 0
Follow-up Well Child Visit 3 STARTED	1019 9	1006 9
Follow-up Well Child Visit 3 COMPLETED	753 9	820 9
Follow-up Well Child Visit 3 NOT COMPLETED	266 0	186 0

Reasons for withdrawal

Reasons for withdrawal
Measure	CSM Theory-based Arm 1. CSM theory-based didactic education and skills training for providers CSM theory-based didactic education and practical skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and how to document the oral health encounter in EMR. 2. Practice EMR changes w/oral health questions Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm AAP-based didactic education (without theory-based training, skills training or EMR changes) AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
Follow-up Well Child Visit 2 Lost to Follow-up	214	160
Follow-up Well Child Visit 2 Withdrawal by Subject	6	3
Follow-up Well Child Visit 3 Lost to Follow-up	266	186

Baseline Characteristics

Analysis was completed separately for each group: Parents/Caregivers (1023), Children (1023), and Providers (62)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Data will be abstracted from Clinical Exams and Medicaid Claims data at baseline and the exit visit at the 24 month follow-up visit.

Population: Any child dental visits through WCV3. The number of children with Medicaid claims data was 865. The number of children with clinical examinations was 675.

Receipt of any dental care (preventive and/or restorative) at approximately 24 months from baseline to the exit visit. Any dental care was defined as yes or no visit.

Outcome measures

Outcome measures
Measure	CSM Theory-based Arm n=448 Participants CSM theory-based didactic education and skills training Practice EMR changes CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm n=417 Participants AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
Dental Attendance Medicaid Claims Data	330 Participants	332 Participants
Dental Attendance Clinical Examination Data	170 Participants	150 Participants

SECONDARY outcome

Timeframe: Dental exams will assess change in dft between baseline well-child visit (WCV#1) and 24 month follow-up exit visit (well-child visit: WCV#3)

Population: The number analyzed is lower than the number enrolled at WCV1 (baseline) due to not all children having an exam at WCV3

dft: number of decayed, missing and filled teeth (dft) at WCV#3 minus the number at WCV#1.

Outcome measures

Outcome measures
Measure	CSM Theory-based Arm n=301 Participants CSM theory-based didactic education and skills training Practice EMR changes CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm n=331 Participants AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
Change in Primary Decayed and Filled Teeth	1.14 teeth Standard Deviation 2.45	1.16 teeth Standard Deviation 2.34

SECONDARY outcome

Timeframe: Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3)

Population: The number analyzed is lower than the number enrolled at WCV1 (baseline) due to some missing data or the study visit not being completed for WCV3

Change in mean number of times per day a child in the study brushed.

Outcome measures

Outcome measures
Measure	CSM Theory-based Arm n=359 Participants CSM theory-based didactic education and skills training Practice EMR changes CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm n=375 Participants AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
Change in Oral Hygiene-brushing	-0.01 mean number of times/day child brushes Standard Deviation 0.63	-0.04 mean number of times/day child brushes Standard Deviation 0.62

SECONDARY outcome

Timeframe: Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit:WCV#3)

Population: The number analyzed is lower than the number enrolled at WCV1 (baseline) due to some missing data or the study visit not being completed for WCV3

Number of sugar-sweetened drinks consumed per day

Outcome measures

Outcome measures
Measure	CSM Theory-based Arm n=357 Participants CSM theory-based didactic education and skills training Practice EMR changes CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm n=365 Participants AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
Change in Diet	0.01 Number of Sugar Sweetened Beverages/Day Standard Deviation 0.88	0.04 Number of Sugar Sweetened Beverages/Day Standard Deviation 0.94

SECONDARY outcome

Timeframe: Assessed as change between baseline well-child visit (WCV #1) and 24 month follow-up exit visit (well-child visit: WCV#3)

Population: The number analyzed is lower than the number enrolled at WCV1 (baseline) due to some missing data or the study visit not being completed for WCV3

Overall score on Early Childhood Oral Health Impact (ECOHIS) Scale with 13 items. Each item is on a Likert scale from 0 through 4. The overall score ranges from 0 to 52. An overall score was calculated for each child, and then a mean calculated for each arm of the study. Lower scores indicate a better oral health quality of life.

Outcome measures

Outcome measures
Measure	CSM Theory-based Arm n=357 Participants CSM theory-based didactic education and skills training Practice EMR changes CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm n=380 Participants AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
Change in Oral Health-related Quality of Life for Child	0.56 scores on a scale Standard Deviation 3.38	0.50 scores on a scale Standard Deviation 3.42

Adverse Events

CSM Theory-based Arm Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CSM Theory-based Arm Parents/Caregivers

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

CSM Theory-based Arm Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AAP-based Arm Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AAP-based Arm Parents/Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AAP-based Arm Providers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CSM Theory-based Arm Children n=517 participants at risk Children enrolled in the CSM theory-based didactic education and skills training Practice EMR changes arm CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	CSM Theory-based Arm Parents/Caregivers n=517 participants at risk Parents/Caregivers enrolled in the CSM theory-based didactic education and skills training Practice EMR changes CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	CSM Theory-based Arm Providers n=27 participants at risk Providers enrolled in the CSM theory-based didactic education and skills training Practice EMR changes CSM theory-based didactic education and skills training: Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR. Practice EMR changes: Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.	AAP-based Arm Children n=506 participants at risk Children enrolled in the AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.	AAP-based Arm Parents/Caregivers n=506 participants at risk Parents/Caregivers enrolled in the AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.	AAP-based Arm Providers n=35 participants at risk Providers enrolled in the AAP-based didactic education AAP-based didactic education: American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
General disorders Death	0.00% 0/517 • Adverse event data was collected from baseline (WCV1) through the exit visit (WCV3). Adverse event information was collected for children, parent/caregivers and providers through communication with participants or family members when contact was made during study visits or during follow-up phone calls for data collection or retention purposes. Adverse events reported were unrelated to the study intervention. Adverse events were monitored after informed consent was received through study completion.	0.39% 2/517 • Number of events 2 • Adverse event data was collected from baseline (WCV1) through the exit visit (WCV3). Adverse event information was collected for children, parent/caregivers and providers through communication with participants or family members when contact was made during study visits or during follow-up phone calls for data collection or retention purposes. Adverse events reported were unrelated to the study intervention. Adverse events were monitored after informed consent was received through study completion.	0.00% 0/27 • Adverse event data was collected from baseline (WCV1) through the exit visit (WCV3). Adverse event information was collected for children, parent/caregivers and providers through communication with participants or family members when contact was made during study visits or during follow-up phone calls for data collection or retention purposes. Adverse events reported were unrelated to the study intervention. Adverse events were monitored after informed consent was received through study completion.	0.00% 0/506 • Adverse event data was collected from baseline (WCV1) through the exit visit (WCV3). Adverse event information was collected for children, parent/caregivers and providers through communication with participants or family members when contact was made during study visits or during follow-up phone calls for data collection or retention purposes. Adverse events reported were unrelated to the study intervention. Adverse events were monitored after informed consent was received through study completion.	0.00% 0/506 • Adverse event data was collected from baseline (WCV1) through the exit visit (WCV3). Adverse event information was collected for children, parent/caregivers and providers through communication with participants or family members when contact was made during study visits or during follow-up phone calls for data collection or retention purposes. Adverse events reported were unrelated to the study intervention. Adverse events were monitored after informed consent was received through study completion.	0.00% 0/35 • Adverse event data was collected from baseline (WCV1) through the exit visit (WCV3). Adverse event information was collected for children, parent/caregivers and providers through communication with participants or family members when contact was made during study visits or during follow-up phone calls for data collection or retention purposes. Adverse events reported were unrelated to the study intervention. Adverse events were monitored after informed consent was received through study completion.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Suchitra Nelson

Case Western Reserve University

Phone: 216-368-3469

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place