- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07377344
CHEER Oral Health in Pregnancy Study (CHEER)
Closing Health Equity Through Empowering Oral Health for Maternal Wellness
Many pregnant people don't get the dental care they need, even though it's safe and important. The CHEER Study offers free dental check-ups, cleanings, and supplies to help participants take care of their teeth and gums during pregnancy. The purpose of this research study is to compare two types of noninvasive oral health interventions to evaluate their effectiveness. We want to learn if one method is more effective in supporting oral health and improving pregnancy outcomes. There are two aims of this study:
Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease.
Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Closing Health Equity through Empowering Oral Health for Maternal Wellness (the CHEER Oral Health in Pregnancy Study) aims to address significant oral health disparities experienced by pregnant individuals, particularly those from low-income and minority communities in California.
Oral health is a critical yet often overlooked component of prenatal care. Existing evidence suggests that periodontal disease is associated with adverse pregnancy outcomes, such as preterm birth and low birth weight. However, many pregnant individuals in California do not receive adequate oral health services, especially those from historically marginalized communities. The CHEER Project aims to address this gap by implementing an intervention that is scalable, community-engaged, and grounded in evidence-based education.
This study will generate novel data on the impact of oral health education and behavior modification, delivered through accessible messaging and product use, on periodontal inflammation and disease status, and microbiome profiles. It will also explore potential downstream effects on perinatal outcomes. The study aligns with public health priorities to improve maternal wellness, health equity, and the integration of dental and medical care.
There are two study aims:
Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease.
Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: CHEER Study Manager
- Phone Number: 415-514-7900
- Email: cheer@ucsf.edu
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- UCSF Dental Center
-
Contact:
- UCSF Dental Center
- Phone Number: 415-514-7900
- Email: cheer@ucsf.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant individuals aged 18 years or older with indications of periodontal diseases (gingivitis or mild periodontitis, moderate to severe periodontitis)
- Less than 20 weeks pregnancy at time of enrollment
- Has dental insurance (Medi-Cal or private coverage)
- Willing and able to provide informed consent
- Planning to receive ongoing prenatal care at study-affiliated clinics
- Access to a mobile phone for receiving text messages
Exclusion Criteria:
- Presence of systemic diseases or medical conditions that require antibiotic prophylaxis for dental procedures
- Current immunosuppressive therapy/use of anti-inflammatory medications
- Receipt of active periodontal treatment within the past 6 months
- Complete edentulism (no natural teeth)
- Unable to read and write English
- Less than 9th grade education
- Enrollment in another oral interventional study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Test
Enhanced Care + receive a home oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys
|
All participants receive standard oral hygiene education at the baseline visit.
Test participants also receive a home oral care kit (toothbrush, toothpaste, and floss), and will start receiving weekly oral health check-ins and reminder surveys following their initial visits at one-week intervals starting the day after their baseline visit
|
|
Other: Control
Participants receive "enhanced care" where they received standard oral hygiene education at the baseline visit.
Do NOT receive oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys
|
All participants receive standard oral hygiene education at the baseline visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in periodontal inflammation
Time Frame: 28 weeks
|
Change in periodontal inflammation by survey and exam from baseline to 28-<36 weeks gestation to postpartum follow-up.
|
28 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in oral health behaviors
Time Frame: 28 weeks
|
Change in patient reported 1) teeth brushing twice a day, 2) teeth brushing for two minutes each time, 3) daily use of floss among test and control participants
|
28 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in birth outcomes between test and control groups
Time Frame: 28 weeks
|
Exploratory outcome: Differences between test and control participants: total weeks gestational age at delivery, preterm birth (<37 gestational weeks), birthweight (in grams), low birth weight delivery (<2500 grams), growth for gestational age percentile, and small for gestational age infant (infant birth weight lower than 10th percentile).
|
28 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Effie Ioannidou, DDS, MDS, University of California, San Francisco
- Principal Investigator: Laura Jelliffe-Pawlowski, PhD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20254330
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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